Evidence map›Paper›PMID 26374429›Full record

Trial reportJournal of the National Cancer Institute2015

Neoadjuvant 5-FU or Capecitabine Plus Radiation With or Without Oxaliplatin in Rectal Cancer Patients: A Phase III Randomized Clinical Trial.

Carmen J Allegra, Greg Yothers, Michael J O'Connell, Robert W Beart, Timothy F Wozniak, Henry C Pitot, Anthony F Shields, Jerome C Landry, David P Ryan, Amit Arora and 12 more

Erratum issued 2 registry-linked trialsOpen access · bronzeAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in Journal of the National Cancer Institute, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to 2 registered trials, which are not on this map. Cited by 148 papers, 14 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
148citing papers in PubMed, 14 pooled it
13.4field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04304209 phase2active not recruitingnot on this mapstarted 2019, after this paper: background citation

Pd1 Antibody Sintilimab ± Chemoradiotherapy for Locally Advanced Rectal Cancer

TypeinterventionalSponsorSun Yat-sen UniversityRan2019 to 2026Enrolled195ConditionsColorectal Cancer Stage II, Colorectal Cancer Stage IIIArmsOxaliplatin, Capecitabine, Sintilimab, radiotherapy, total mesorectal excision
NCT05136326 phase2recruitingnot on this mapstarted 2021, after this paper: background citation

Multicenter Phase II Study of Preoperative Chemoradiotherapy With CApecitabine Plus Temozolomide in Patients With MGMT Silenced and Microsatellite Stable Locally Advanced RecTal Cancer: the CATARTIC Trial

TypeinterventionalSponsorFondazione IRCCS Istituto Nazionale dei Tumori, MilanoRan2021 to 2026Enrolled21ConditionsRectal CancerArmsExternal-beam radiation, Capecitabine, Temozolomide
3 · Its place in the literature

Who cites it

148 citing papers in PubMed, 14 syntheses or guidelines pooled it, 327 citations in OpenAlex.

  1. Pooled it
  2. Guideline
  3. Pooled it
  4. Pooled it
  5. Pooled it
  6. Guideline
  7. Executive Summary of the American Radium Society Appropriate Use Criteria for Treatment of Anal Cancer.International journal of radiation oncology, biology, physics · 2019
    Pooled it
  8. Pooled it
  9. Pooled it
  10. Rectal Cancer, Version 2.2018, NCCN Clinical Practice Guidelines in Oncology.Journal of the National Comprehensive Cancer Network : JNCCN · 2018
    Guideline
  11. Oral versus intravenous fluoropyrimidines for colorectal cancer.The Cochrane database of systematic reviews · 2017
    Pooled it
  12. Pooled it
  13. Pooled it
  14. Pooled it
  15. Trial
  16. Overall side effect assessment of oxaliplatin toxicity in rectal cancer patients in NRG oncology/NSABP R04.Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2024
    Trial
  17. Preoperative Treatment of Locally Advanced Rectal Cancer.The New England journal of medicine · 2023
    Trial
  18. Trial
  19. Trial
  20. Organ Preservation in Patients With Rectal Adenocarcinoma Treated With Total Neoadjuvant Therapy.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2022
    Trial

88 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

22 authors at 11 institutions in 1 country.

Carmen J AllegraNRG Oncology/National Surgical Adjuvant Breast and Bowel Project, Pittsburgh, PA (CJA, GY, MJO, RWB, TFW, HCP, AFS, JCL, DPR, AA, LSE, NB, GS, JFE, JMR, DFMJr, MRM, BTM, PJW, SS, MSR, NW); Department of Medicine, University of Florida Health, Gainesville, FL (CJA); NRG Oncology and the University of Pittsburgh Graduate School of Public Health, Department of Biostatistics, Pittsburgh, PA (GY); Glendale Memorial Hospital, Glendale, CA (RWB); CCOP Christiana Care Health Systems, Newark, DE (TFW); Mayo Clinic, Rochester, MN and the ALLIANCE, Boston, MA (HCP); Wayne State University, Karmanos Cancer Institute, Detroit, MI and SWOG, San Antonio, TX (AFS); Emory University, Department of Radiation Oncology, Atlanta, GA and ECOG/ACRIN, Rochester, MN (JCL); Massachusetts General Hospital Cancer Center and the ALLIANCE, Boston, MA (DPR); Kaiser Permanente, Fremont, CA (AA); Novant Health Forsyth Medical Center, Winston-Salem, NC (LSE); University of Pittsburgh, Pittsburgh, PA (NB); Missouri Valley Cancer Consortium CCOP, Omaha, NE (GS); Florida Cancer Specialists, Fort Myers, FL (JFE); Beaumont Hospital System, Royal Oak, MI (JMR); Cancer Center of Kansas, Wichita, KS (DFMJr); Stroger Hospital Chicago MU-NCORP, Chicago, IL (MRM); Montana Cancer Consortium, Billings, MT (BTM); Oncology and Hematology Care, Cincinnati, OH (PJW); UF Health Cancer Center, Orlando FL (MSR); Allegheny Cancer Center at Allegheny General Hospital, Pittsburgh, PA (NW). carmen.allegra@medicine.ufl.edu.
Greg YothersNRG Oncology/National Surgical Adjuvant Breast and Bowel Project, Pittsburgh, PA (CJA, GY, MJO, RWB, TFW, HCP, AFS, JCL, DPR, AA, LSE, NB, GS, JFE, JMR, DFMJr, MRM, BTM, PJW, SS, MSR, NW); Department of Medicine, University of Florida Health, Gainesville, FL (CJA); NRG Oncology and the University of Pittsburgh Graduate School of Public Health, Department of Biostatistics, Pittsburgh, PA (GY); Glendale Memorial Hospital, Glendale, CA (RWB); CCOP Christiana Care Health Systems, Newark, DE (TFW); Mayo Clinic, Rochester, MN and the ALLIANCE, Boston, MA (HCP); Wayne State University, Karmanos Cancer Institute, Detroit, MI and SWOG, San Antonio, TX (AFS); Emory University, Department of Radiation Oncology, Atlanta, GA and ECOG/ACRIN, Rochester, MN (JCL); Massachusetts General Hospital Cancer Center and the ALLIANCE, Boston, MA (DPR); Kaiser Permanente, Fremont, CA (AA); Novant Health Forsyth Medical Center, Winston-Salem, NC (LSE); University of Pittsburgh, Pittsburgh, PA (NB); Missouri Valley Cancer Consortium CCOP, Omaha, NE (GS); Florida Cancer Specialists, Fort Myers, FL (JFE); Beaumont Hospital System, Royal Oak, MI (JMR); Cancer Center of Kansas, Wichita, KS (DFMJr); Stroger Hospital Chicago MU-NCORP, Chicago, IL (MRM); Montana Cancer Consortium, Billings, MT (BTM); Oncology and Hematology Care, Cincinnati, OH (PJW); UF Health Cancer Center, Orlando FL (MSR); Allegheny Cancer Center at Allegheny General Hospital, Pittsburgh, PA (NW).
Michael J O'ConnellNRG Oncology/National Surgical Adjuvant Breast and Bowel Project, Pittsburgh, PA (CJA, GY, MJO, RWB, TFW, HCP, AFS, JCL, DPR, AA, LSE, NB, GS, JFE, JMR, DFMJr, MRM, BTM, PJW, SS, MSR, NW); Department of Medicine, University of Florida Health, Gainesville, FL (CJA); NRG Oncology and the University of Pittsburgh Graduate School of Public Health, Department of Biostatistics, Pittsburgh, PA (GY); Glendale Memorial Hospital, Glendale, CA (RWB); CCOP Christiana Care Health Systems, Newark, DE (TFW); Mayo Clinic, Rochester, MN and the ALLIANCE, Boston, MA (HCP); Wayne State University, Karmanos Cancer Institute, Detroit, MI and SWOG, San Antonio, TX (AFS); Emory University, Department of Radiation Oncology, Atlanta, GA and ECOG/ACRIN, Rochester, MN (JCL); Massachusetts General Hospital Cancer Center and the ALLIANCE, Boston, MA (DPR); Kaiser Permanente, Fremont, CA (AA); Novant Health Forsyth Medical Center, Winston-Salem, NC (LSE); University of Pittsburgh, Pittsburgh, PA (NB); Missouri Valley Cancer Consortium CCOP, Omaha, NE (GS); Florida Cancer Specialists, Fort Myers, FL (JFE); Beaumont Hospital System, Royal Oak, MI (JMR); Cancer Center of Kansas, Wichita, KS (DFMJr); Stroger Hospital Chicago MU-NCORP, Chicago, IL (MRM); Montana Cancer Consortium, Billings, MT (BTM); Oncology and Hematology Care, Cincinnati, OH (PJW); UF Health Cancer Center, Orlando FL (MSR); Allegheny Cancer Center at Allegheny General Hospital, Pittsburgh, PA (NW).
Robert W BeartNRG Oncology/National Surgical Adjuvant Breast and Bowel Project, Pittsburgh, PA (CJA, GY, MJO, RWB, TFW, HCP, AFS, JCL, DPR, AA, LSE, NB, GS, JFE, JMR, DFMJr, MRM, BTM, PJW, SS, MSR, NW); Department of Medicine, University of Florida Health, Gainesville, FL (CJA); NRG Oncology and the University of Pittsburgh Graduate School of Public Health, Department of Biostatistics, Pittsburgh, PA (GY); Glendale Memorial Hospital, Glendale, CA (RWB); CCOP Christiana Care Health Systems, Newark, DE (TFW); Mayo Clinic, Rochester, MN and the ALLIANCE, Boston, MA (HCP); Wayne State University, Karmanos Cancer Institute, Detroit, MI and SWOG, San Antonio, TX (AFS); Emory University, Department of Radiation Oncology, Atlanta, GA and ECOG/ACRIN, Rochester, MN (JCL); Massachusetts General Hospital Cancer Center and the ALLIANCE, Boston, MA (DPR); Kaiser Permanente, Fremont, CA (AA); Novant Health Forsyth Medical Center, Winston-Salem, NC (LSE); University of Pittsburgh, Pittsburgh, PA (NB); Missouri Valley Cancer Consortium CCOP, Omaha, NE (GS); Florida Cancer Specialists, Fort Myers, FL (JFE); Beaumont Hospital System, Royal Oak, MI (JMR); Cancer Center of Kansas, Wichita, KS (DFMJr); Stroger Hospital Chicago MU-NCORP, Chicago, IL (MRM); Montana Cancer Consortium, Billings, MT (BTM); Oncology and Hematology Care, Cincinnati, OH (PJW); UF Health Cancer Center, Orlando FL (MSR); Allegheny Cancer Center at Allegheny General Hospital, Pittsburgh, PA (NW).
Timothy F WozniakNRG Oncology/National Surgical Adjuvant Breast and Bowel Project, Pittsburgh, PA (CJA, GY, MJO, RWB, TFW, HCP, AFS, JCL, DPR, AA, LSE, NB, GS, JFE, JMR, DFMJr, MRM, BTM, PJW, SS, MSR, NW); Department of Medicine, University of Florida Health, Gainesville, FL (CJA); NRG Oncology and the University of Pittsburgh Graduate School of Public Health, Department of Biostatistics, Pittsburgh, PA (GY); Glendale Memorial Hospital, Glendale, CA (RWB); CCOP Christiana Care Health Systems, Newark, DE (TFW); Mayo Clinic, Rochester, MN and the ALLIANCE, Boston, MA (HCP); Wayne State University, Karmanos Cancer Institute, Detroit, MI and SWOG, San Antonio, TX (AFS); Emory University, Department of Radiation Oncology, Atlanta, GA and ECOG/ACRIN, Rochester, MN (JCL); Massachusetts General Hospital Cancer Center and the ALLIANCE, Boston, MA (DPR); Kaiser Permanente, Fremont, CA (AA); Novant Health Forsyth Medical Center, Winston-Salem, NC (LSE); University of Pittsburgh, Pittsburgh, PA (NB); Missouri Valley Cancer Consortium CCOP, Omaha, NE (GS); Florida Cancer Specialists, Fort Myers, FL (JFE); Beaumont Hospital System, Royal Oak, MI (JMR); Cancer Center of Kansas, Wichita, KS (DFMJr); Stroger Hospital Chicago MU-NCORP, Chicago, IL (MRM); Montana Cancer Consortium, Billings, MT (BTM); Oncology and Hematology Care, Cincinnati, OH (PJW); UF Health Cancer Center, Orlando FL (MSR); Allegheny Cancer Center at Allegheny General Hospital, Pittsburgh, PA (NW).
Henry C PitotNRG Oncology/National Surgical Adjuvant Breast and Bowel Project, Pittsburgh, PA (CJA, GY, MJO, RWB, TFW, HCP, AFS, JCL, DPR, AA, LSE, NB, GS, JFE, JMR, DFMJr, MRM, BTM, PJW, SS, MSR, NW); Department of Medicine, University of Florida Health, Gainesville, FL (CJA); NRG Oncology and the University of Pittsburgh Graduate School of Public Health, Department of Biostatistics, Pittsburgh, PA (GY); Glendale Memorial Hospital, Glendale, CA (RWB); CCOP Christiana Care Health Systems, Newark, DE (TFW); Mayo Clinic, Rochester, MN and the ALLIANCE, Boston, MA (HCP); Wayne State University, Karmanos Cancer Institute, Detroit, MI and SWOG, San Antonio, TX (AFS); Emory University, Department of Radiation Oncology, Atlanta, GA and ECOG/ACRIN, Rochester, MN (JCL); Massachusetts General Hospital Cancer Center and the ALLIANCE, Boston, MA (DPR); Kaiser Permanente, Fremont, CA (AA); Novant Health Forsyth Medical Center, Winston-Salem, NC (LSE); University of Pittsburgh, Pittsburgh, PA (NB); Missouri Valley Cancer Consortium CCOP, Omaha, NE (GS); Florida Cancer Specialists, Fort Myers, FL (JFE); Beaumont Hospital System, Royal Oak, MI (JMR); Cancer Center of Kansas, Wichita, KS (DFMJr); Stroger Hospital Chicago MU-NCORP, Chicago, IL (MRM); Montana Cancer Consortium, Billings, MT (BTM); Oncology and Hematology Care, Cincinnati, OH (PJW); UF Health Cancer Center, Orlando FL (MSR); Allegheny Cancer Center at Allegheny General Hospital, Pittsburgh, PA (NW).
Anthony F ShieldsNRG Oncology/National Surgical Adjuvant Breast and Bowel Project, Pittsburgh, PA (CJA, GY, MJO, RWB, TFW, HCP, AFS, JCL, DPR, AA, LSE, NB, GS, JFE, JMR, DFMJr, MRM, BTM, PJW, SS, MSR, NW); Department of Medicine, University of Florida Health, Gainesville, FL (CJA); NRG Oncology and the University of Pittsburgh Graduate School of Public Health, Department of Biostatistics, Pittsburgh, PA (GY); Glendale Memorial Hospital, Glendale, CA (RWB); CCOP Christiana Care Health Systems, Newark, DE (TFW); Mayo Clinic, Rochester, MN and the ALLIANCE, Boston, MA (HCP); Wayne State University, Karmanos Cancer Institute, Detroit, MI and SWOG, San Antonio, TX (AFS); Emory University, Department of Radiation Oncology, Atlanta, GA and ECOG/ACRIN, Rochester, MN (JCL); Massachusetts General Hospital Cancer Center and the ALLIANCE, Boston, MA (DPR); Kaiser Permanente, Fremont, CA (AA); Novant Health Forsyth Medical Center, Winston-Salem, NC (LSE); University of Pittsburgh, Pittsburgh, PA (NB); Missouri Valley Cancer Consortium CCOP, Omaha, NE (GS); Florida Cancer Specialists, Fort Myers, FL (JFE); Beaumont Hospital System, Royal Oak, MI (JMR); Cancer Center of Kansas, Wichita, KS (DFMJr); Stroger Hospital Chicago MU-NCORP, Chicago, IL (MRM); Montana Cancer Consortium, Billings, MT (BTM); Oncology and Hematology Care, Cincinnati, OH (PJW); UF Health Cancer Center, Orlando FL (MSR); Allegheny Cancer Center at Allegheny General Hospital, Pittsburgh, PA (NW).
Jerome C LandryNRG Oncology/National Surgical Adjuvant Breast and Bowel Project, Pittsburgh, PA (CJA, GY, MJO, RWB, TFW, HCP, AFS, JCL, DPR, AA, LSE, NB, GS, JFE, JMR, DFMJr, MRM, BTM, PJW, SS, MSR, NW); Department of Medicine, University of Florida Health, Gainesville, FL (CJA); NRG Oncology and the University of Pittsburgh Graduate School of Public Health, Department of Biostatistics, Pittsburgh, PA (GY); Glendale Memorial Hospital, Glendale, CA (RWB); CCOP Christiana Care Health Systems, Newark, DE (TFW); Mayo Clinic, Rochester, MN and the ALLIANCE, Boston, MA (HCP); Wayne State University, Karmanos Cancer Institute, Detroit, MI and SWOG, San Antonio, TX (AFS); Emory University, Department of Radiation Oncology, Atlanta, GA and ECOG/ACRIN, Rochester, MN (JCL); Massachusetts General Hospital Cancer Center and the ALLIANCE, Boston, MA (DPR); Kaiser Permanente, Fremont, CA (AA); Novant Health Forsyth Medical Center, Winston-Salem, NC (LSE); University of Pittsburgh, Pittsburgh, PA (NB); Missouri Valley Cancer Consortium CCOP, Omaha, NE (GS); Florida Cancer Specialists, Fort Myers, FL (JFE); Beaumont Hospital System, Royal Oak, MI (JMR); Cancer Center of Kansas, Wichita, KS (DFMJr); Stroger Hospital Chicago MU-NCORP, Chicago, IL (MRM); Montana Cancer Consortium, Billings, MT (BTM); Oncology and Hematology Care, Cincinnati, OH (PJW); UF Health Cancer Center, Orlando FL (MSR); Allegheny Cancer Center at Allegheny General Hospital, Pittsburgh, PA (NW).
David P RyanNRG Oncology/National Surgical Adjuvant Breast and Bowel Project, Pittsburgh, PA (CJA, GY, MJO, RWB, TFW, HCP, AFS, JCL, DPR, AA, LSE, NB, GS, JFE, JMR, DFMJr, MRM, BTM, PJW, SS, MSR, NW); Department of Medicine, University of Florida Health, Gainesville, FL (CJA); NRG Oncology and the University of Pittsburgh Graduate School of Public Health, Department of Biostatistics, Pittsburgh, PA (GY); Glendale Memorial Hospital, Glendale, CA (RWB); CCOP Christiana Care Health Systems, Newark, DE (TFW); Mayo Clinic, Rochester, MN and the ALLIANCE, Boston, MA (HCP); Wayne State University, Karmanos Cancer Institute, Detroit, MI and SWOG, San Antonio, TX (AFS); Emory University, Department of Radiation Oncology, Atlanta, GA and ECOG/ACRIN, Rochester, MN (JCL); Massachusetts General Hospital Cancer Center and the ALLIANCE, Boston, MA (DPR); Kaiser Permanente, Fremont, CA (AA); Novant Health Forsyth Medical Center, Winston-Salem, NC (LSE); University of Pittsburgh, Pittsburgh, PA (NB); Missouri Valley Cancer Consortium CCOP, Omaha, NE (GS); Florida Cancer Specialists, Fort Myers, FL (JFE); Beaumont Hospital System, Royal Oak, MI (JMR); Cancer Center of Kansas, Wichita, KS (DFMJr); Stroger Hospital Chicago MU-NCORP, Chicago, IL (MRM); Montana Cancer Consortium, Billings, MT (BTM); Oncology and Hematology Care, Cincinnati, OH (PJW); UF Health Cancer Center, Orlando FL (MSR); Allegheny Cancer Center at Allegheny General Hospital, Pittsburgh, PA (NW).
Amit AroraNRG Oncology/National Surgical Adjuvant Breast and Bowel Project, Pittsburgh, PA (CJA, GY, MJO, RWB, TFW, HCP, AFS, JCL, DPR, AA, LSE, NB, GS, JFE, JMR, DFMJr, MRM, BTM, PJW, SS, MSR, NW); Department of Medicine, University of Florida Health, Gainesville, FL (CJA); NRG Oncology and the University of Pittsburgh Graduate School of Public Health, Department of Biostatistics, Pittsburgh, PA (GY); Glendale Memorial Hospital, Glendale, CA (RWB); CCOP Christiana Care Health Systems, Newark, DE (TFW); Mayo Clinic, Rochester, MN and the ALLIANCE, Boston, MA (HCP); Wayne State University, Karmanos Cancer Institute, Detroit, MI and SWOG, San Antonio, TX (AFS); Emory University, Department of Radiation Oncology, Atlanta, GA and ECOG/ACRIN, Rochester, MN (JCL); Massachusetts General Hospital Cancer Center and the ALLIANCE, Boston, MA (DPR); Kaiser Permanente, Fremont, CA (AA); Novant Health Forsyth Medical Center, Winston-Salem, NC (LSE); University of Pittsburgh, Pittsburgh, PA (NB); Missouri Valley Cancer Consortium CCOP, Omaha, NE (GS); Florida Cancer Specialists, Fort Myers, FL (JFE); Beaumont Hospital System, Royal Oak, MI (JMR); Cancer Center of Kansas, Wichita, KS (DFMJr); Stroger Hospital Chicago MU-NCORP, Chicago, IL (MRM); Montana Cancer Consortium, Billings, MT (BTM); Oncology and Hematology Care, Cincinnati, OH (PJW); UF Health Cancer Center, Orlando FL (MSR); Allegheny Cancer Center at Allegheny General Hospital, Pittsburgh, PA (NW).
Lisa S EvansNRG Oncology/National Surgical Adjuvant Breast and Bowel Project, Pittsburgh, PA (CJA, GY, MJO, RWB, TFW, HCP, AFS, JCL, DPR, AA, LSE, NB, GS, JFE, JMR, DFMJr, MRM, BTM, PJW, SS, MSR, NW); Department of Medicine, University of Florida Health, Gainesville, FL (CJA); NRG Oncology and the University of Pittsburgh Graduate School of Public Health, Department of Biostatistics, Pittsburgh, PA (GY); Glendale Memorial Hospital, Glendale, CA (RWB); CCOP Christiana Care Health Systems, Newark, DE (TFW); Mayo Clinic, Rochester, MN and the ALLIANCE, Boston, MA (HCP); Wayne State University, Karmanos Cancer Institute, Detroit, MI and SWOG, San Antonio, TX (AFS); Emory University, Department of Radiation Oncology, Atlanta, GA and ECOG/ACRIN, Rochester, MN (JCL); Massachusetts General Hospital Cancer Center and the ALLIANCE, Boston, MA (DPR); Kaiser Permanente, Fremont, CA (AA); Novant Health Forsyth Medical Center, Winston-Salem, NC (LSE); University of Pittsburgh, Pittsburgh, PA (NB); Missouri Valley Cancer Consortium CCOP, Omaha, NE (GS); Florida Cancer Specialists, Fort Myers, FL (JFE); Beaumont Hospital System, Royal Oak, MI (JMR); Cancer Center of Kansas, Wichita, KS (DFMJr); Stroger Hospital Chicago MU-NCORP, Chicago, IL (MRM); Montana Cancer Consortium, Billings, MT (BTM); Oncology and Hematology Care, Cincinnati, OH (PJW); UF Health Cancer Center, Orlando FL (MSR); Allegheny Cancer Center at Allegheny General Hospital, Pittsburgh, PA (NW).
Nathan BaharyNRG Oncology/National Surgical Adjuvant Breast and Bowel Project, Pittsburgh, PA (CJA, GY, MJO, RWB, TFW, HCP, AFS, JCL, DPR, AA, LSE, NB, GS, JFE, JMR, DFMJr, MRM, BTM, PJW, SS, MSR, NW); Department of Medicine, University of Florida Health, Gainesville, FL (CJA); NRG Oncology and the University of Pittsburgh Graduate School of Public Health, Department of Biostatistics, Pittsburgh, PA (GY); Glendale Memorial Hospital, Glendale, CA (RWB); CCOP Christiana Care Health Systems, Newark, DE (TFW); Mayo Clinic, Rochester, MN and the ALLIANCE, Boston, MA (HCP); Wayne State University, Karmanos Cancer Institute, Detroit, MI and SWOG, San Antonio, TX (AFS); Emory University, Department of Radiation Oncology, Atlanta, GA and ECOG/ACRIN, Rochester, MN (JCL); Massachusetts General Hospital Cancer Center and the ALLIANCE, Boston, MA (DPR); Kaiser Permanente, Fremont, CA (AA); Novant Health Forsyth Medical Center, Winston-Salem, NC (LSE); University of Pittsburgh, Pittsburgh, PA (NB); Missouri Valley Cancer Consortium CCOP, Omaha, NE (GS); Florida Cancer Specialists, Fort Myers, FL (JFE); Beaumont Hospital System, Royal Oak, MI (JMR); Cancer Center of Kansas, Wichita, KS (DFMJr); Stroger Hospital Chicago MU-NCORP, Chicago, IL (MRM); Montana Cancer Consortium, Billings, MT (BTM); Oncology and Hematology Care, Cincinnati, OH (PJW); UF Health Cancer Center, Orlando FL (MSR); Allegheny Cancer Center at Allegheny General Hospital, Pittsburgh, PA (NW).
Gamini SooriNRG Oncology/National Surgical Adjuvant Breast and Bowel Project, Pittsburgh, PA (CJA, GY, MJO, RWB, TFW, HCP, AFS, JCL, DPR, AA, LSE, NB, GS, JFE, JMR, DFMJr, MRM, BTM, PJW, SS, MSR, NW); Department of Medicine, University of Florida Health, Gainesville, FL (CJA); NRG Oncology and the University of Pittsburgh Graduate School of Public Health, Department of Biostatistics, Pittsburgh, PA (GY); Glendale Memorial Hospital, Glendale, CA (RWB); CCOP Christiana Care Health Systems, Newark, DE (TFW); Mayo Clinic, Rochester, MN and the ALLIANCE, Boston, MA (HCP); Wayne State University, Karmanos Cancer Institute, Detroit, MI and SWOG, San Antonio, TX (AFS); Emory University, Department of Radiation Oncology, Atlanta, GA and ECOG/ACRIN, Rochester, MN (JCL); Massachusetts General Hospital Cancer Center and the ALLIANCE, Boston, MA (DPR); Kaiser Permanente, Fremont, CA (AA); Novant Health Forsyth Medical Center, Winston-Salem, NC (LSE); University of Pittsburgh, Pittsburgh, PA (NB); Missouri Valley Cancer Consortium CCOP, Omaha, NE (GS); Florida Cancer Specialists, Fort Myers, FL (JFE); Beaumont Hospital System, Royal Oak, MI (JMR); Cancer Center of Kansas, Wichita, KS (DFMJr); Stroger Hospital Chicago MU-NCORP, Chicago, IL (MRM); Montana Cancer Consortium, Billings, MT (BTM); Oncology and Hematology Care, Cincinnati, OH (PJW); UF Health Cancer Center, Orlando FL (MSR); Allegheny Cancer Center at Allegheny General Hospital, Pittsburgh, PA (NW).
Janice F EakleNRG Oncology/National Surgical Adjuvant Breast and Bowel Project, Pittsburgh, PA (CJA, GY, MJO, RWB, TFW, HCP, AFS, JCL, DPR, AA, LSE, NB, GS, JFE, JMR, DFMJr, MRM, BTM, PJW, SS, MSR, NW); Department of Medicine, University of Florida Health, Gainesville, FL (CJA); NRG Oncology and the University of Pittsburgh Graduate School of Public Health, Department of Biostatistics, Pittsburgh, PA (GY); Glendale Memorial Hospital, Glendale, CA (RWB); CCOP Christiana Care Health Systems, Newark, DE (TFW); Mayo Clinic, Rochester, MN and the ALLIANCE, Boston, MA (HCP); Wayne State University, Karmanos Cancer Institute, Detroit, MI and SWOG, San Antonio, TX (AFS); Emory University, Department of Radiation Oncology, Atlanta, GA and ECOG/ACRIN, Rochester, MN (JCL); Massachusetts General Hospital Cancer Center and the ALLIANCE, Boston, MA (DPR); Kaiser Permanente, Fremont, CA (AA); Novant Health Forsyth Medical Center, Winston-Salem, NC (LSE); University of Pittsburgh, Pittsburgh, PA (NB); Missouri Valley Cancer Consortium CCOP, Omaha, NE (GS); Florida Cancer Specialists, Fort Myers, FL (JFE); Beaumont Hospital System, Royal Oak, MI (JMR); Cancer Center of Kansas, Wichita, KS (DFMJr); Stroger Hospital Chicago MU-NCORP, Chicago, IL (MRM); Montana Cancer Consortium, Billings, MT (BTM); Oncology and Hematology Care, Cincinnati, OH (PJW); UF Health Cancer Center, Orlando FL (MSR); Allegheny Cancer Center at Allegheny General Hospital, Pittsburgh, PA (NW).
John M RobertsonNRG Oncology/National Surgical Adjuvant Breast and Bowel Project, Pittsburgh, PA (CJA, GY, MJO, RWB, TFW, HCP, AFS, JCL, DPR, AA, LSE, NB, GS, JFE, JMR, DFMJr, MRM, BTM, PJW, SS, MSR, NW); Department of Medicine, University of Florida Health, Gainesville, FL (CJA); NRG Oncology and the University of Pittsburgh Graduate School of Public Health, Department of Biostatistics, Pittsburgh, PA (GY); Glendale Memorial Hospital, Glendale, CA (RWB); CCOP Christiana Care Health Systems, Newark, DE (TFW); Mayo Clinic, Rochester, MN and the ALLIANCE, Boston, MA (HCP); Wayne State University, Karmanos Cancer Institute, Detroit, MI and SWOG, San Antonio, TX (AFS); Emory University, Department of Radiation Oncology, Atlanta, GA and ECOG/ACRIN, Rochester, MN (JCL); Massachusetts General Hospital Cancer Center and the ALLIANCE, Boston, MA (DPR); Kaiser Permanente, Fremont, CA (AA); Novant Health Forsyth Medical Center, Winston-Salem, NC (LSE); University of Pittsburgh, Pittsburgh, PA (NB); Missouri Valley Cancer Consortium CCOP, Omaha, NE (GS); Florida Cancer Specialists, Fort Myers, FL (JFE); Beaumont Hospital System, Royal Oak, MI (JMR); Cancer Center of Kansas, Wichita, KS (DFMJr); Stroger Hospital Chicago MU-NCORP, Chicago, IL (MRM); Montana Cancer Consortium, Billings, MT (BTM); Oncology and Hematology Care, Cincinnati, OH (PJW); UF Health Cancer Center, Orlando FL (MSR); Allegheny Cancer Center at Allegheny General Hospital, Pittsburgh, PA (NW).
Dennis F MooreNRG Oncology/National Surgical Adjuvant Breast and Bowel Project, Pittsburgh, PA (CJA, GY, MJO, RWB, TFW, HCP, AFS, JCL, DPR, AA, LSE, NB, GS, JFE, JMR, DFMJr, MRM, BTM, PJW, SS, MSR, NW); Department of Medicine, University of Florida Health, Gainesville, FL (CJA); NRG Oncology and the University of Pittsburgh Graduate School of Public Health, Department of Biostatistics, Pittsburgh, PA (GY); Glendale Memorial Hospital, Glendale, CA (RWB); CCOP Christiana Care Health Systems, Newark, DE (TFW); Mayo Clinic, Rochester, MN and the ALLIANCE, Boston, MA (HCP); Wayne State University, Karmanos Cancer Institute, Detroit, MI and SWOG, San Antonio, TX (AFS); Emory University, Department of Radiation Oncology, Atlanta, GA and ECOG/ACRIN, Rochester, MN (JCL); Massachusetts General Hospital Cancer Center and the ALLIANCE, Boston, MA (DPR); Kaiser Permanente, Fremont, CA (AA); Novant Health Forsyth Medical Center, Winston-Salem, NC (LSE); University of Pittsburgh, Pittsburgh, PA (NB); Missouri Valley Cancer Consortium CCOP, Omaha, NE (GS); Florida Cancer Specialists, Fort Myers, FL (JFE); Beaumont Hospital System, Royal Oak, MI (JMR); Cancer Center of Kansas, Wichita, KS (DFMJr); Stroger Hospital Chicago MU-NCORP, Chicago, IL (MRM); Montana Cancer Consortium, Billings, MT (BTM); Oncology and Hematology Care, Cincinnati, OH (PJW); UF Health Cancer Center, Orlando FL (MSR); Allegheny Cancer Center at Allegheny General Hospital, Pittsburgh, PA (NW).
Michael R MullaneNRG Oncology/National Surgical Adjuvant Breast and Bowel Project, Pittsburgh, PA (CJA, GY, MJO, RWB, TFW, HCP, AFS, JCL, DPR, AA, LSE, NB, GS, JFE, JMR, DFMJr, MRM, BTM, PJW, SS, MSR, NW); Department of Medicine, University of Florida Health, Gainesville, FL (CJA); NRG Oncology and the University of Pittsburgh Graduate School of Public Health, Department of Biostatistics, Pittsburgh, PA (GY); Glendale Memorial Hospital, Glendale, CA (RWB); CCOP Christiana Care Health Systems, Newark, DE (TFW); Mayo Clinic, Rochester, MN and the ALLIANCE, Boston, MA (HCP); Wayne State University, Karmanos Cancer Institute, Detroit, MI and SWOG, San Antonio, TX (AFS); Emory University, Department of Radiation Oncology, Atlanta, GA and ECOG/ACRIN, Rochester, MN (JCL); Massachusetts General Hospital Cancer Center and the ALLIANCE, Boston, MA (DPR); Kaiser Permanente, Fremont, CA (AA); Novant Health Forsyth Medical Center, Winston-Salem, NC (LSE); University of Pittsburgh, Pittsburgh, PA (NB); Missouri Valley Cancer Consortium CCOP, Omaha, NE (GS); Florida Cancer Specialists, Fort Myers, FL (JFE); Beaumont Hospital System, Royal Oak, MI (JMR); Cancer Center of Kansas, Wichita, KS (DFMJr); Stroger Hospital Chicago MU-NCORP, Chicago, IL (MRM); Montana Cancer Consortium, Billings, MT (BTM); Oncology and Hematology Care, Cincinnati, OH (PJW); UF Health Cancer Center, Orlando FL (MSR); Allegheny Cancer Center at Allegheny General Hospital, Pittsburgh, PA (NW).
Benjamin T MarchelloNRG Oncology/National Surgical Adjuvant Breast and Bowel Project, Pittsburgh, PA (CJA, GY, MJO, RWB, TFW, HCP, AFS, JCL, DPR, AA, LSE, NB, GS, JFE, JMR, DFMJr, MRM, BTM, PJW, SS, MSR, NW); Department of Medicine, University of Florida Health, Gainesville, FL (CJA); NRG Oncology and the University of Pittsburgh Graduate School of Public Health, Department of Biostatistics, Pittsburgh, PA (GY); Glendale Memorial Hospital, Glendale, CA (RWB); CCOP Christiana Care Health Systems, Newark, DE (TFW); Mayo Clinic, Rochester, MN and the ALLIANCE, Boston, MA (HCP); Wayne State University, Karmanos Cancer Institute, Detroit, MI and SWOG, San Antonio, TX (AFS); Emory University, Department of Radiation Oncology, Atlanta, GA and ECOG/ACRIN, Rochester, MN (JCL); Massachusetts General Hospital Cancer Center and the ALLIANCE, Boston, MA (DPR); Kaiser Permanente, Fremont, CA (AA); Novant Health Forsyth Medical Center, Winston-Salem, NC (LSE); University of Pittsburgh, Pittsburgh, PA (NB); Missouri Valley Cancer Consortium CCOP, Omaha, NE (GS); Florida Cancer Specialists, Fort Myers, FL (JFE); Beaumont Hospital System, Royal Oak, MI (JMR); Cancer Center of Kansas, Wichita, KS (DFMJr); Stroger Hospital Chicago MU-NCORP, Chicago, IL (MRM); Montana Cancer Consortium, Billings, MT (BTM); Oncology and Hematology Care, Cincinnati, OH (PJW); UF Health Cancer Center, Orlando FL (MSR); Allegheny Cancer Center at Allegheny General Hospital, Pittsburgh, PA (NW).
Patrick J WardNRG Oncology/National Surgical Adjuvant Breast and Bowel Project, Pittsburgh, PA (CJA, GY, MJO, RWB, TFW, HCP, AFS, JCL, DPR, AA, LSE, NB, GS, JFE, JMR, DFMJr, MRM, BTM, PJW, SS, MSR, NW); Department of Medicine, University of Florida Health, Gainesville, FL (CJA); NRG Oncology and the University of Pittsburgh Graduate School of Public Health, Department of Biostatistics, Pittsburgh, PA (GY); Glendale Memorial Hospital, Glendale, CA (RWB); CCOP Christiana Care Health Systems, Newark, DE (TFW); Mayo Clinic, Rochester, MN and the ALLIANCE, Boston, MA (HCP); Wayne State University, Karmanos Cancer Institute, Detroit, MI and SWOG, San Antonio, TX (AFS); Emory University, Department of Radiation Oncology, Atlanta, GA and ECOG/ACRIN, Rochester, MN (JCL); Massachusetts General Hospital Cancer Center and the ALLIANCE, Boston, MA (DPR); Kaiser Permanente, Fremont, CA (AA); Novant Health Forsyth Medical Center, Winston-Salem, NC (LSE); University of Pittsburgh, Pittsburgh, PA (NB); Missouri Valley Cancer Consortium CCOP, Omaha, NE (GS); Florida Cancer Specialists, Fort Myers, FL (JFE); Beaumont Hospital System, Royal Oak, MI (JMR); Cancer Center of Kansas, Wichita, KS (DFMJr); Stroger Hospital Chicago MU-NCORP, Chicago, IL (MRM); Montana Cancer Consortium, Billings, MT (BTM); Oncology and Hematology Care, Cincinnati, OH (PJW); UF Health Cancer Center, Orlando FL (MSR); Allegheny Cancer Center at Allegheny General Hospital, Pittsburgh, PA (NW).
Saima SharifNRG Oncology/National Surgical Adjuvant Breast and Bowel Project, Pittsburgh, PA (CJA, GY, MJO, RWB, TFW, HCP, AFS, JCL, DPR, AA, LSE, NB, GS, JFE, JMR, DFMJr, MRM, BTM, PJW, SS, MSR, NW); Department of Medicine, University of Florida Health, Gainesville, FL (CJA); NRG Oncology and the University of Pittsburgh Graduate School of Public Health, Department of Biostatistics, Pittsburgh, PA (GY); Glendale Memorial Hospital, Glendale, CA (RWB); CCOP Christiana Care Health Systems, Newark, DE (TFW); Mayo Clinic, Rochester, MN and the ALLIANCE, Boston, MA (HCP); Wayne State University, Karmanos Cancer Institute, Detroit, MI and SWOG, San Antonio, TX (AFS); Emory University, Department of Radiation Oncology, Atlanta, GA and ECOG/ACRIN, Rochester, MN (JCL); Massachusetts General Hospital Cancer Center and the ALLIANCE, Boston, MA (DPR); Kaiser Permanente, Fremont, CA (AA); Novant Health Forsyth Medical Center, Winston-Salem, NC (LSE); University of Pittsburgh, Pittsburgh, PA (NB); Missouri Valley Cancer Consortium CCOP, Omaha, NE (GS); Florida Cancer Specialists, Fort Myers, FL (JFE); Beaumont Hospital System, Royal Oak, MI (JMR); Cancer Center of Kansas, Wichita, KS (DFMJr); Stroger Hospital Chicago MU-NCORP, Chicago, IL (MRM); Montana Cancer Consortium, Billings, MT (BTM); Oncology and Hematology Care, Cincinnati, OH (PJW); UF Health Cancer Center, Orlando FL (MSR); Allegheny Cancer Center at Allegheny General Hospital, Pittsburgh, PA (NW).
Mark S RohNRG Oncology/National Surgical Adjuvant Breast and Bowel Project, Pittsburgh, PA (CJA, GY, MJO, RWB, TFW, HCP, AFS, JCL, DPR, AA, LSE, NB, GS, JFE, JMR, DFMJr, MRM, BTM, PJW, SS, MSR, NW); Department of Medicine, University of Florida Health, Gainesville, FL (CJA); NRG Oncology and the University of Pittsburgh Graduate School of Public Health, Department of Biostatistics, Pittsburgh, PA (GY); Glendale Memorial Hospital, Glendale, CA (RWB); CCOP Christiana Care Health Systems, Newark, DE (TFW); Mayo Clinic, Rochester, MN and the ALLIANCE, Boston, MA (HCP); Wayne State University, Karmanos Cancer Institute, Detroit, MI and SWOG, San Antonio, TX (AFS); Emory University, Department of Radiation Oncology, Atlanta, GA and ECOG/ACRIN, Rochester, MN (JCL); Massachusetts General Hospital Cancer Center and the ALLIANCE, Boston, MA (DPR); Kaiser Permanente, Fremont, CA (AA); Novant Health Forsyth Medical Center, Winston-Salem, NC (LSE); University of Pittsburgh, Pittsburgh, PA (NB); Missouri Valley Cancer Consortium CCOP, Omaha, NE (GS); Florida Cancer Specialists, Fort Myers, FL (JFE); Beaumont Hospital System, Royal Oak, MI (JMR); Cancer Center of Kansas, Wichita, KS (DFMJr); Stroger Hospital Chicago MU-NCORP, Chicago, IL (MRM); Montana Cancer Consortium, Billings, MT (BTM); Oncology and Hematology Care, Cincinnati, OH (PJW); UF Health Cancer Center, Orlando FL (MSR); Allegheny Cancer Center at Allegheny General Hospital, Pittsburgh, PA (NW).
Norman WolmarkNRG Oncology/National Surgical Adjuvant Breast and Bowel Project, Pittsburgh, PA (CJA, GY, MJO, RWB, TFW, HCP, AFS, JCL, DPR, AA, LSE, NB, GS, JFE, JMR, DFMJr, MRM, BTM, PJW, SS, MSR, NW); Department of Medicine, University of Florida Health, Gainesville, FL (CJA); NRG Oncology and the University of Pittsburgh Graduate School of Public Health, Department of Biostatistics, Pittsburgh, PA (GY); Glendale Memorial Hospital, Glendale, CA (RWB); CCOP Christiana Care Health Systems, Newark, DE (TFW); Mayo Clinic, Rochester, MN and the ALLIANCE, Boston, MA (HCP); Wayne State University, Karmanos Cancer Institute, Detroit, MI and SWOG, San Antonio, TX (AFS); Emory University, Department of Radiation Oncology, Atlanta, GA and ECOG/ACRIN, Rochester, MN (JCL); Massachusetts General Hospital Cancer Center and the ALLIANCE, Boston, MA (DPR); Kaiser Permanente, Fremont, CA (AA); Novant Health Forsyth Medical Center, Winston-Salem, NC (LSE); University of Pittsburgh, Pittsburgh, PA (NB); Missouri Valley Cancer Consortium CCOP, Omaha, NE (GS); Florida Cancer Specialists, Fort Myers, FL (JFE); Beaumont Hospital System, Royal Oak, MI (JMR); Cancer Center of Kansas, Wichita, KS (DFMJr); Stroger Hospital Chicago MU-NCORP, Chicago, IL (MRM); Montana Cancer Consortium, Billings, MT (BTM); Oncology and Hematology Care, Cincinnati, OH (PJW); UF Health Cancer Center, Orlando FL (MSR); Allegheny Cancer Center at Allegheny General Hospital, Pittsburgh, PA (NW).
NSABP Foundation · USNRG Oncology · USUniversity of Florida Health · USAllegheny General Hospital · USCancer Center of Kansas · USEmory University · USFlorida Cancer Specialists & Research Institute · USMassachusetts General Hospital · USNovant Health Forsyth Medical Center · USUniversity of Pittsburgh · USWayne State University · US

Funding

NRG Oncology Network Group Operations Center - GY9 BIQSFP Reports/BudgetsU10CA180868 · NCI · NRG ONCOLOGY FOUNDATION, INC. · PI NORMAN WOLMARK · 2014 to 2026
$206.8M
Member Site CoreU10CA180821 · NCI · BRIGHAM AND WOMEN'S HOSPITAL · PI Evanthia Galanis · 2014 to 2026
$177.3M
Project-006U10CA180820 · NCI · ECOG-ACRIN MEDICAL RESEARCH FOUNDATION · PI Peter J ODwyer, MITCHELL D. SCHNALL · 2014 to 2026
$167.6M
SWOG Network Group Operations Center of the NCTNU10CA180888 · NCI · UNIVERSITY OF CALIFORNIA AT DAVIS · PI PRIMO N. LARA · 2014 to 2026
$152.1M
Statistics CoreU10CA180822 · NCI · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI Mei-Yin C Polley · 2014 to 2026
$146.4M
NRG Oncology NCORP Research Base-BIQSFPUG1CA189867 · NCI · NRG ONCOLOGY FOUNDATION, INC. · PI Deborah Watkins Bruner, Lisa A. Kachnic · 2014 to 2026
$140.5M
NCTN Lead Academic Participating Site at Dana-Farber/Partners Cancer CareU10CA180867 · NCI · DANA-FARBER CANCER INST · PI BURSTEIN, HAROLD JOHN, KIBEL, ADAM S · 2014 to 2018
$6.2M
NCI NIH HHS U10 CA180820NCI NIH HHS U10-CA180820NCI NIH HHS U10 CA180821NCI NIH HHS U10-CA180821NCI NIH HHS U10 CA180822NCI NIH HHS U10-CA180822NCI NIH HHS U10 CA180867NCI NIH HHS U10 CA180868NCI NIH HHS U10-CA180868NCI NIH HHS U10 CA180888NCI NIH HHS U10-CA180888NCI NIH HHS UG1 CA189867NCI NIH HHS UG1-CA189867
6 · The paper itself

Abstract

backgroundNational Surgical Adjuvant Breast and Bowel Project R-04 was designed to determine whether the oral fluoropyrimidine capecitabine could be substituted for continuous infusion 5-FU in the curative setting of stage II/III rectal cancer during neoadjuvant radiation therapy and whether the addition of oxaliplatin could further enhance the activity of fluoropyrimidine-sensitized radiation.

methodsPatients with clinical stage II or III rectal cancer undergoing preoperative radiation were randomly assigned to one of four chemotherapy regimens in a 2x2 design: CVI 5-FU or oral capecitabine with or without oxaliplatin. The primary endpoint was local-regional tumor control. Time-to-event endpoint distributions were estimated using the Kaplan-Meier method. Hazard ratios were estimated from Cox proportional hazard models. All statistical tests were two-sided.

resultsAmong 1608 randomized patients there were no statistically significant differences between regimens using 5-FU vs capecitabine in three-year local-regional tumor event rates (11.2% vs 11.8%), 5-year DFS (66.4% vs 67.7%), or 5-year OS (79.9% vs 80.8%); or for oxaliplatin vs no oxaliplatin for the three endpoints of local-regional events, DFS, and OS (11.2% vs 12.1%, 69.2% vs 64.2%, and 81.3% vs 79.0%). The addition of oxaliplatin was associated with statistically significantly more overall and grade 3-4 diarrhea (P < .0001). Three-year rates of local-regional recurrence among patients who underwent R0 resection ranged from 3.1 to 5.1% depending on the study arm.

conclusionsContinuous infusion 5-FU produced outcomes for local-regional control, DFS, and OS similar to those obtained with oral capecitabine combined with radiation. This study establishes capecitabine as a standard of care in the pre-operative rectal setting. Oxaliplatin did not improve the local-regional failure rate, DFS, or OS for any patient risk group but did add considerable toxicity.

Indexed as

AdultAgedAntimetabolites, AntineoplasticAntineoplastic Combined Chemotherapy ProtocolsCapecitabineChemotherapy, AdjuvantDeoxycytidineDrug Administration ScheduleFemaleFluorouracilHumansMaleMiddle AgedNeoadjuvant TherapyOrganoplatinum CompoundsOxaliplatinAntimetabolites, AntineoplasticCapecitabineDeoxycytidineFluorouracilOrganoplatinum CompoundsOxaliplatin

Identifiers

PMID26374429
PMCPMC4849360
OpenAlexW2212807488

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