Evidence map›Paper›PMID 21277694›Full record

Trial reportInternational journal of radiation oncology, biology, physics2012

Failure to adhere to protocol specified radiation therapy guidelines was associated with decreased survival in RTOG 9704--a phase III trial of adjuvant chemotherapy and chemoradiotherapy for patients with resected adenocarcinoma of the pancreas.

Ross A Abrams, Kathryn A Winter, William F Regine, Howard Safran, John P Hoffman, Robert Lustig, Andre A Konski, Al B Benson, John S Macdonald, Tyvin A Rich and 1 more

Registry-linked trialOpen access · greenAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in International journal of radiation oncology, biology, physics, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00003216 (A Phase III Study of Pre and Post Chemoradiation 5-FU vs. Pre and Post Chemoradiation Gemcitabine for Postoperative Adjuvant Treatment of Resected Pancreatic Adenocarcinoma), which is not on this map. Cited by 122 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
122citing papers in PubMed, 5 pooled it
8.6field-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.

NCT00003216 phase3completednot on this map

A Phase III Study of Pre and Post Chemoradiation 5-FU vs. Pre and Post Chemoradiation Gemcitabine for Postoperative Adjuvant Treatment of Resected Pancreatic Adenocarcinoma

TypeinterventionalSponsorRadiation Therapy Oncology GroupRan1998Enrolled518ConditionsPancreatic CancerArmsfluorouracil, gemcitabine hydrochloride, radiation therapy
3 · Its place in the literature

Who cites it

122 citing papers in PubMed, 5 syntheses or guidelines pooled it, 269 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Guideline
  6. Trial
  7. Trial
  8. The radiotherapy quality assurance gap among phase III cancer clinical trials.Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology · 2022
    Trial
  9. Trial
  10. Trial
  11. Trial
  12. Trial
  13. Trial
  14. Comparison of investigator-delineated gross tumour volumes and quality assurance in pancreatic cancer: Analysis of the on-trial cases for the SCALOP trial.Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology · 2016
    Trial
  15. Trial
  16. Trial
  17. Trial
  18. Trial
  19. Trial
  20. Beyond theJCO precision oncology · 2026
    Review

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

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

11 authors at 10 institutions in 1 country.

Ross A AbramsDepartment of Radiation Oncology, Rush University Medical Center, Chicago, IL 60612, USA.
Kathryn A Winter
William F Regine
Howard Safran
John P Hoffman
Robert Lustig
Andre A Konski
Al B Benson
John S Macdonald
Tyvin A Rich
Christopher G Willett
RTOG Foundation · USBrown University · USDuke University · USFox Chase Cancer Center · USNorthwestern University · USRush University Medical Center · USSaint Vincent Health System · USUniversity of Maryland, Baltimore · USUniversity of Virginia · USWayne State University · US

Funding

RTOG Foreign AccrualU10CA021661 · NCI · AMERICAN COLLEGE OF RADIOLOGY · PI CURRAN, WALTER J. · 1985 to 2013
$150.3M
RTOG Foreign AccrualsU10CA037422 · NCI · AMERICAN COLLEGE OF RADIOLOGY · PI BRUNER, DEBORAH WATKINS · 1985 to 2013
$30.4M
MULTIDISCIPLINARY CLINICAL AND TRANSLATIONAL SCIENCE (MCTS) PROGRAM (UL1)UL1RR025741 · NCRR · NORTHWESTERN UNIVERSITY AT CHICAGO · PI GREENLAND, PHILIP · 2008 to 2011
$24.7M
NCI NIH HHS CA21661NCI NIH HHS CA37422NCI NIH HHS U10 CA021661NCI NIH HHS U10 CA037422NCRR NIH HHS UL1 RR025741
6 · The paper itself

Abstract

purposeIn Radiation Therapy Oncology Group 9704, as previously published, patients with resected pancreatic adenocarcinoma received continuous infusion 5-FU and concurrent radiotherapy (5FU-RT). 5FU-RT treatment was preceded and followed by randomly assigned chemotherapy, either 5-FU or gemcitabine. This analysis explored whether failure to adhere to specified RT guidelines influenced survival and/or toxicity. METHODS AND MATERIALS: RT requirements were protocol specified. Adherence was scored as per protocol (PP) or less than per protocol (<PP). Scoring occurred after therapy but before trial analysis and without knowledge of individual patient treatment outcomes. Scoring was done for all tumor locations and for the subset of pancreatic head location.

resultsRT was scored for 416 patients: 216 PP and 200 <PP. For all pancreatic sites (head, body/tail) median survival (MS) for PP vs. <PP was 1.74 vs. 1.46 years (log-rank p = 0.0077). In multivariate analysis, PP vs. <PP score correlated more strongly with MS than assigned treatment arm (p = 0.014, p = NS, respectively); for patients with pancreatic head tumors, both PP score and gemcitabine treatment correlated with improved MS (p = 0.016, p = 0.043, respectively). For all tumor locations, PP score was associated with decreased risk of failure (p = 0.016) and, for gemcitabine patients, a trend toward reduced Grade 4/5 nonhematologic toxicity (p = 0.065).

conclusionsThis is the first Phase III, multicenter, adjuvant protocol for pancreatic adenocarcinoma to evaluate the impact of adherence to specified RT protocol guidelines on protocol outcomes. Failure to adhere to specified RT guidelines was associated with reduced survival and, for patients receiving gemcitabine, trend toward increased nonhematologic toxicity.

Indexed as

Guideline AdherenceAdenocarcinomaAdultAgedAged, 80 and overAntimetabolites, AntineoplasticChemoradiotherapyChemotherapy, AdjuvantDeoxycytidineFemaleFluorouracilGemcitabineHumansMaleMiddle AgedMultivariate AnalysisAntimetabolites, AntineoplasticDeoxycytidineFluorouracilGemcitabine

Identifiers

PMID21277694
PMCPMC3133855
OpenAlexW2032111846

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

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.