Evidence map›Paper›PMID 29233486›Full record

Trial reportClinical colorectal cancer2018

Cetuximab Combined With Induction Oxaliplatin and Capecitabine, Followed by Neoadjuvant Chemoradiation for Locally Advanced Rectal Cancer: SWOG 0713.

Cynthia Gail Leichman, Shannon L McDonough, Stephen R Smalley, Kevin G Billingsley, Heinz-Josef Lenz, Matthew A Beldner, Aram F Hezel, Mario R Velasco, Katherine A Guthrie, Charles D Blanke and 1 more

Abstract readClinical Trial, Phase II
In one paragraph

Trial report in Clinical colorectal cancer, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed, 3 pooled it
0.9field-weighted citation impact, top 23% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

12 citing papers in PubMed, 3 syntheses or guidelines pooled it, 25 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Cell-free DNA and preoperative chemoradiotherapy for rectal cancer: a systematic review.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2019
    Pooled it
  4. Trial
  5. Trial
  6. Review
  7. Review
  8. Review
  9. Article
  10. Review
  11. Coelomic Fluid ofEvidence-based complementary and alternative medicine : eCAM · 2020
    Article
  12. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors at 8 institutions in 1 country.

Cynthia Gail LeichmanDivision of Medical Oncology, New York University, New York, NY. Electronic address: leichman1@cox.net.
Shannon L McDonoughSWOG Statistics and Data Management Center, Seattle, WA.
Stephen R SmalleyRadiation Oncology Center of Olathe, Olathe, KS.
Kevin G BillingsleyDivision of Surgical Oncology, Oregon Health & Science University, Portland, OR.
Heinz-Josef LenzDivision of Medical Oncology, Keck School of Medicine, University of Southern California, Los Angeles, CA.
Matthew A BeldnerSoutheast Cancer Control Consortium-Upstate NCORP/Lowcountry Hematology Oncology, Mt Pleasant, SC.
Aram F HezelDepartment of Medicine, Wilmot Cancer Center, University of Rochester Medical Center, Rochester, NY.
Mario R VelascoHeartland NCORP/Cancer Care Specialists of Central Illinois, Decatur, IL.
Katherine A GuthrieSWOG Statistics and Data Management Center, Seattle, WA.
Charles D BlankeSWOG Group Chair's Office/Oregon Health & Science University, Portland, OR.
Howard S HochsterDepartment of Oncology, Yale University, New Haven, CT.
Oregon Health & Science University · USCancer Care Specialists of Illinois · USColumbia University Irving Medical Center · USOlathe Medical Center · USSoutheast Clinical Oncology Research Consortium · USUniversity of Rochester Medical Center · USUniversity of Southern California · USYale University · US

Funding

SWOG Network Group Operations Center of the NCTNU10CA180888 · NCI · UNIVERSITY OF CALIFORNIA AT DAVIS · PI PRIMO N. LARA · 2014 to 2026
$152.1M
SWOG Statistics & Data Management Center complex - extension supplement for GY06U10CA180819 · NCI · FRED HUTCHINSON CANCER RESEARCH CENTER · PI Michael L. LeBlanc · 2014 to 2026
$115.2M
Heartland Cancer Research NCORPUG1CA189830 · NCI · DECATUR MEMORIAL HOSPITAL · PI Bryan A. Faller · 2014 to 2026
$40.9M
Southeast Clinical Oncology Research Consortium, Inc. (SCOR)UG1CA189858 · NCI · SOUTHEAST CLINICAL ONCOL RES CONSORTIUM · PI Judith O Hopkins, William J Irvin · 2014 to 2026
$38.8M
Cancer Research Consortium of West Michigan (CRCWM)UG1CA189860 · NCI · COREWELL HEALTH · PI KATHLEEN YOST BUTLER · 2014 to 2026
$29.1M
The Pacific Cancer Research Consortium (PCRC), an NCORP Community SiteUG1CA189953 · NCI · SWEDISH MEDICAL CENTER, FIRST HILL · PI Alison Katherine Conlin, Charles Drescher · 2014 to 2026
$27.4M
UPSTATE CAROLINA COMMUNITY CLINICAL ONCOLOGY PROGRAMU10CA035119 · NCI · SPARTANBURG REGIONAL MEDICAL CENTER · PI BEARDEN, JAMES D · 1985 to 2013
$21.5M
Dayton Clinical Oncology ProgramUG1CA189957 · NCI · DAYTON CLINICAL ONCOLOGY PROGRAM · PI Howard M Gross · 2014 to 2026
$10.7M
National Community Oncology Research ProjectUG1CA189808 · NCI · VIA CHRISTI REGIONAL MEDICAL CENTER · PI DAKHIL, SHAKER R · 2014 to 2018
$8.6M
SOUTHWEST ONCOLOGY GROUPU10CA011083 · NCI · UNIVERSITY OF ROCHESTER · PI FRIEDBERG, JONATHAN W · 1985 to 2013
$5.5M
SOUTHWEST ONCOLOGY GROUP CA13612U10CA013612 · NCI · UNIVERSITY OF ARIZONA · PI CRANMER, LEE D · 1985 to 2013
$4.5M
UM LAPs- U10 GrantU10CA180801 · NCI · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI ZALUPSKI, MARK M · 2014 to 2018
$3.7M
NCI NIH HHS N01 CA013612NCI NIH HHS N01 CA035119NCI NIH HHS U10 CA011083NCI NIH HHS U10 CA012644NCI NIH HHS U10 CA013612NCI NIH HHS U10 CA016385NCI NIH HHS U10 CA035119NCI NIH HHS U10 CA052654NCI NIH HHS U10 CA058416NCI NIH HHS U10 CA068183NCI NIH HHS U10 CA180801NCI NIH HHS U10 CA180819NCI NIH HHS U10 CA180830NCI NIH HHS U10 CA180888NCI NIH HHS UG1 CA180830NCI NIH HHS UG1 CA189808NCI NIH HHS UG1 CA189830NCI NIH HHS UG1 CA189858NCI NIH HHS UG1 CA189860NCI NIH HHS UG1 CA189953NCI NIH HHS UG1 CA189957
6 · The paper itself

Abstract

backgroundNeoadjuvant chemoradiation (NCRT) is standard treatment for locally advanced rectal cancer. Pathologic complete response (pCR) has associated with improved survival. In modern phase III trials of NCRT, pCR ranges from 10% to 20%. Cetuximab improves response in KRAS (KRAS proto-oncogene) wild type (wt) metastatic colorectal cancer. S0713 was designed to assess improvement in pCR with additional use of cetuximab with induction chemotherapy and NCRT for locally advanced, KRAS-wt rectal cancer. PATIENTS AND

methodsPatient eligibility: stage II to III biopsy-proven, KRAS-wt rectal adenocarcinoma; no bowel obstruction; adequate hematologic, hepatic and renal function; performance status of 0 to 2. Target enrollment: 80 patients. TREATMENT: induction chemotherapy with wCAPOX (weekly capecitabine and oxaliplatin) and cetuximab followed by the same regimen concurrent with radiation (omitting day 15 oxaliplatin). If fewer than 7 pCRs were observed at planned interim analysis after 40 patients received all therapy, the study would close. Eighty eligible patients would provide 90% power given a true pCR rate > 35% at a significance of 0.04. The regimen would lack future interest if pCR probability was ≤ 20%.

resultsBetween February 2009 and April 2013, 83 patients registered. Four were ineligible and 4 not treated, leaving 75 evaluable for clinical outcomes and toxicity, of whom 65 had surgery. Of 75 patients, 20 had pCR (27%; 95% confidence interval [CI], 17%-38%); 19 (25%) had microscopic cancer; 36 (48%) had minor/no response (including 10 without surgery). Three-year disease-free survival was 73% (95% CI, 63%-83%).

conclusionOur trial did not meet the pCR target of 35%. Toxicity was generally acceptable. This regimen cannot be recommended outside the clinical trial setting.

Indexed as

AdenocarcinomaAdultAgedAntineoplastic Combined Chemotherapy ProtocolsCapecitabineCetuximabChemoradiotherapy, AdjuvantDisease-Free SurvivalFemaleHumansInduction ChemotherapyKaplan-Meier EstimateMaleMiddle AgedNeoadjuvant TherapyOxaliplatinCapecitabineCetuximabMAS1 protein, humanOxaliplatinProto-Oncogene MasChemotherapyCooperative group trialKRASpCRPhase II

Identifiers

PMID29233486
PMCPMC6598683
OpenAlexW2765975486

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.