Evidence map›Paper›PMID 31985516›Full record

Trial reportAmerican journal of clinical oncology2020

Results of the NRG Oncology/RTOG 0848 Adjuvant Chemotherapy Question-Erlotinib+Gemcitabine for Resected Cancer of the Pancreatic Head: A Phase II Randomized Clinical Trial.

Ross A Abrams, Kathryn A Winter, Howard Safran, Karyn A Goodman, William F Regine, Adam C Berger, Michael T Gillin, Philip A Philip, Andrew M Lowy, Abraham Wu and 11 more

Open access · greenAbstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in American journal of clinical oncology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 25 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
25citing papers in PubMed, 1 pooled it
3.6field-weighted citation impact, top 5% 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

25 citing papers in PubMed, 1 synthesis or guideline pooled it, 62 citations in OpenAlex.

  1. Guideline
  2. Article
  3. Article
  4. Article
  5. Review
  6. Review
  7. Review
  8. Review
  9. Article
  10. Article
  11. Analysis of Radiation Therapy Quality Assurance in NRG Oncology RTOG 0848.International journal of radiation oncology, biology, physics · 2024
    Article
  12. Review
  13. Neoadjuvant therapy for pancreatic cancer.Nature reviews. Clinical oncology · 2023
    Review
  14. Article
  15. Article
  16. Adjuvant Chemoradiotherapy in Resected Pancreatic Ductal Adenocarcinoma: Where Does the Benefit Lie? A Nomogram for Risk Stratification and Patient Selection.Journal of gastrointestinal surgery : official journal of the Society for Surgery of the Alimentary Tract · 2022
    Article
  17. Recurrence patterns of pancreatic cancer treated with adjuvant intensity modulated radiotherapy.Reports of practical oncology and radiotherapy : journal of Greatpoland Cancer Center in Poznan and Polish Society of Radiation Oncology · 2022
    Article
  18. Review
  19. Review
  20. 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

21 authors at 14 institutions in 3 countries.

Ross A AbramsRush University Medical Center, Chicago, IL.
Kathryn A WinterNRG Oncology Statistics and Data Management Center.
Howard SafranRhode Island Hospital.
Karyn A GoodmanUniversity of Colorado Cancer Center, Denver, CO.
William F RegineUniversity of Maryland/Greenebaum Cancer Center, Baltimore, MD.
Adam C BergerThomas Jefferson University Hospital, Philadelphia, PA.
Michael T GillinMD Anderson Cancer Center, Houston, TX.
Philip A PhilipWayne State University/Karmanos Cancer Institute, Detroit, MI.
Andrew M LowyUC San Diego Moores Cancer Center, San Diego.
Abraham WuMemorial Sloan Kettering Cancer, New York.
Thomas A DiPetrilloRush University Medical Center, Chicago, IL.
Benjamin W CornTel Aviv Sourasky Medical Center, Tel Aviv, Israel.
Samantha A SeawardDepartment of Radiation Oncology; Kaiser Permanente East Bay Cancer Center, Oakland, CA.
Michael G HaddockMayo Clinic, Rochester, MN.
Suisui SongUSC/Norris Comprehensive Cancer Center, Los Angeles, CA.
Yixing JiangUniversity of Maryland/Greenebaum Cancer Center, Baltimore, MD.
Barbara J FisherLondon Regional Cancer Program, London, ON, Canada.
Alan W KatzUniversity of Rochester, Rochester, NY.
Sharmila MehtaSpartanburg Regional Medical Center, Spartanburg, SC.
Christopher G WillettDuke University Medical Center, Durham, NC.
Christopher H CraneMemorial Sloan Kettering Cancer, New York.
Rhode Island Hospital · USUniversity of Colorado Denver · USNRG Oncology · USRush University Medical Center · USThomas Jefferson University Hospital · USCancer Care Ontario · CAKaiser Permanente · USSpartanburg Regional Medical Center · USThe Barbara Ann Karmanos Cancer Institute · USThe University of Texas MD Anderson Cancer Center · USU-M Rogel Cancer CenterUniversity of Maryland, Baltimore · USUniversity of Rochester · USUSC Norris Comprehensive Cancer Center · US

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Nicholas D Socci · 1985 to 2026
$347.4M
NRG Oncology Network Group Operations Center - GY9 BIQSFP Reports/BudgetsU10CA180868 · NCI · NRG ONCOLOGY FOUNDATION, INC. · PI NORMAN WOLMARK · 2014 to 2026
$206.8M
SWOG Network Group Operations Center of the NCTNU10CA180888 · NCI · UNIVERSITY OF CALIFORNIA AT DAVIS · PI PRIMO N. LARA · 2014 to 2026
$152.1M
RTOG Foreign AccrualU10CA021661 · NCI · AMERICAN COLLEGE OF RADIOLOGY · PI CURRAN, WALTER J. · 1985 to 2013
$150.3M
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
IROC: Enhancing local enrolling site radiological data capture capabilities for NCTN trialsU24CA180803 · NCI · AMERICAN COLLEGE OF RADIOLOGY · PI Thomas J. FitzGerald, MICHAEL V KNOPP · 2014 to 2026
$116.2M
Network Lead Academic Participating Site: Memorial Sloan Kettering Cancer CenterUG1CA233290 · NCI · SLOAN-KETTERING INST CAN RESEARCH · PI CAROL AGHAJANIAN, Darren Feldman · 2019 to 2026
$10.2M
NCI National Clinical Trials Network - Lead Academic Participating SiteUG1CA233324 · NCI · UNIVERSITY OF COLORADO DENVER · PI ANTHONY D ELIAS · 2019 to 2026
$5.2M
NCI National Clinical Trials Network – Network Lead Academic Participating SiteUG1CA233163 · NCI · WAYNE STATE UNIVERSITY · PI FLAHERTY, LAWRENCE E, SHIELDS, ANTHONY FRANK · 2019 to 2025
$3.5M
NCI NIH HHS P30 CA008748NCI NIH HHS U10 CA021661NCI NIH HHS U10 CA180822NCI NIH HHS U10 CA180868NCI NIH HHS U10 CA180888NCI NIH HHS U24 CA180803NCI NIH HHS UG1 CA189867NCI NIH HHS UG1 CA233163NCI NIH HHS UG1 CA233290NCI NIH HHS UG1 CA233324
6 · The paper itself

Abstract

purposeNRG/RTOG 0848 was designed to determine whether adjuvant radiation with fluoropyrimidine sensitization improved survival following gemcitabine-based adjuvant chemotherapy for patients with resected pancreatic head adenocarcinoma. In step 1 of this protocol, patients were randomized to adjuvant gemcitabine versus the combination of gemcitabine and erlotinib. This manuscript reports the final analysis of these step 1 data.

methodsEligibility-within 10 weeks of curative intent pancreaticoduodenectomy with postoperative CA19-9<180. Gemcitabine arm-6 cycles of gemcitabine. Gemcitabine+erlotinib arm-gemcitabine and erlotinib 100 mg/d. Two hundred deaths provided 90% power (1-sided α=0.15) to detect the hypothesized OS signal (hazard ratio=0.72) in favor of the arm 2.

resultsFrom November 17, 2009 to February 28, 2014, 163 patients were randomized and evaluable for arm 1 and 159 for arm 2. Median age was 63 (39 to 86) years. CA19-9 ≤90 in 93%. Arm 1: 32 patients (20%) grade 4 and 2 (1%) grade 5 adverse events; arm 2, 27 (17%) grade 4 and 3 (2%) grade 5. GI adverse events, arm 1: 22% grade ≥3 and arm 2: 28%, (P=0.22). The median follow-up (surviving patients) was 42.5 months (min-max: <1 to 75). With 203 deaths, the median and 3-year OS (95% confidence interval) are 29.9 months (21.7, 33.4) and 39% (30, 45) for arm 1 and 28.1 months (20.7, 30.9) and 39% (31, 47) for arm 2 (log-rank P=0.62). Hazard ratio (95% confidence interval) comparing OS of arm 2 to arm 1 is 1.04 (0.79, 1.38).

conclusionsThe addition of adjuvant erlotinib to gemcitabine did not provide a signal for increased OS in this trial.

Indexed as

AdenocarcinomaAdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsChemotherapy, AdjuvantDeoxycytidineErlotinib HydrochlorideFemaleGemcitabineHumansMaleMiddle AgedPancreatic NeoplasmsDeoxycytidineErlotinib HydrochlorideGemcitabine

Identifiers

PMID31985516
PMCPMC7280743
OpenAlexW3003778095

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.