Evidence map›Paper›PMID 19581537›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2009

Phase III, randomized study of gemcitabine and oxaliplatin versus gemcitabine (fixed-dose rate infusion) compared with gemcitabine (30-minute infusion) in patients with pancreatic carcinoma E6201: a trial of the Eastern Cooperative Oncology Group.

Elizabeth Poplin, Yang Feng, Jordan Berlin, Mace L Rothenberg, Howard Hochster, Edith Mitchell, Steven Alberts, Peter O'Dwyer, Daniel Haller, Paul Catalano and 2 more

Erratum issued Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase IIIComparative StudyMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2009. 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 trial NCT00058149 (A Phase III, Randomized Study of Gemcitabine), which is not on this map. Cited by 182 papers, 19 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
182citing papers in PubMed, 19 pooled it
21.0field-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.

NCT00058149 phase3completednot on this map

A Phase III, Randomized Study of Gemcitabine (Fixed-Dose Rate Infusion) and Oxaliplatin (NSC 266046) Versus Gemcitabine (Fixed-Dose Rate Infusion) Versus Gemcitabine (30-Minute Infusion) in Pancreatic Carcinoma

TypeinterventionalSponsorEastern Cooperative Oncology GroupRan2003ConditionsPancreatic CancerArmsgemcitabine hydrochloride, oxaliplatin
3 · Its place in the literature

Who cites it

182 citing papers in PubMed, 19 syntheses or guidelines pooled it, 431 citations in OpenAlex.

  1. Chemotherapy and radiotherapy for advanced pancreatic cancer.The Cochrane database of systematic reviews · 2024
    Pooled it
  2. Pooled it
  3. Pooled it
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  5. Chemotherapy and radiotherapy for advanced pancreatic cancer.The Cochrane database of systematic reviews · 2018
    Pooled it
  6. Pooled it
  7. Pooled it
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  9. Metastatic Pancreatic Cancer: American Society of Clinical Oncology Clinical Practice Guideline.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2016
    Guideline
  10. Pooled it
  11. Pooled it
  12. Pooled it
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  15. Pooled it
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  17. Pancreatic adenocarcinoma.Journal of the National Comprehensive Cancer Network : JNCCN · 2010
    Guideline
  18. Pooled it
  19. Pooled it
  20. Trial

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

4 · The record

Corrections and comments

  • Erratum issued
5 · Who and what money

Authors and funding

12 authors at 7 institutions in 2 countries.

Elizabeth PoplinCancer Institute of New Jersey,195 Little Albany St, New Brunswick, NJ 08903, USA. poplinea@umdnj.edu
Yang Feng
Jordan Berlin
Mace L Rothenberg
Howard Hochster
Edith Mitchell
Steven Alberts
Peter O'Dwyer
Daniel Haller
Paul Catalano
David Cella
Al Bowen Benson
New York University · USUniversity Hospital and Clinics · USNorthwestern Medicine · USPalmetto Hematology Oncology · USRutgers Cancer Institute of New JerseyThomas Jefferson University · USUniversity Medical Center · US

Funding

ECOG OPERATIONS OFFICE (IBCSG)U10CA021115 · NCI · UNIVERSITY OF WISCONSIN MADISON · PI COMIS, ROBERT L · 1985 to 2013
$132.6M
TRANSLATIONAL RESEARCHU10CA025224 · NCI · MAYO CLINIC ROCHESTER · PI BUCKNER, JAN C · 1985 to 2013
$85.0M
ECOG Statistical Office Data Management GrantU10CA066636 · NCI · FRONTIER SCI &TECHNOLOGY RSCH FDN, INC · PI GRAY, ROBERT J · 1994 to 2013
$39.5M
PROVIDE STATISTICAL SERVICESU10CA023318 · NCI · DANA-FARBER CANCER INSTITUTE · PI GRAY, ROBERT J · 1985 to 2013
$33.4M
MULTIDISCIPLINARY CLINICAL AND TRANSLATIONAL SCIENCE (MCTS) PROGRAM (UL1)UL1RR025741 · NCRR · NORTHWESTERN UNIVERSITY AT CHICAGO · PI GREENLAND, PHILIP · 2008 to 2011
$24.7M
ECOG Specimen BankingU24CA114737 · NCI · FRONTIER SCI &TECHNOLOGY RSCH FDN, INC · PI COMIS, ROBERT L · 2005 to 2014
$9.3M
ECOG Clinical TrialsU10CA017145 · NCI · NORTHWESTERN UNIVERSITY AT CHICAGO · PI BENSON, AL B · 1985 to 2013
$6.1M
NCI NIH HHS CA17145NCI NIH HHS CA21115NCI NIH HHS CA23318NCI NIH HHS CA25224NCI NIH HHS CA66636NCI NIH HHS U10 CA017145NCI NIH HHS U10 CA021115NCI NIH HHS U10 CA023318NCI NIH HHS U10 CA025224NCI NIH HHS U10 CA066636NCI NIH HHS U24 CA114737NCRR NIH HHS UL1 RR025741
6 · The paper itself

Abstract

purposeSingle-agent gemcitabine (GEM) is standard treatment of metastatic pancreatic cancer. Fixed-dose rate (FDR) GEM and GEM plus oxaliplatin have shown promise in early clinical trials. E6201 was designed to compare overall survival (OS) of standard weekly GEM 1,000 mg/m(2)/30 minutes versus GEM FDR 1,500 mg/m(2)/150 minutes or GEM 1,000 mg/m(2)/100 minutes/day 1 plus oxaliplatin 100 mg/m(2)/day 2 every 14 days (GEMOX).

methodsThis trial included patients with metastatic or locally advanced pancreatic cancer, normal organ function, and performance status of 0 to 2. The study was designed to detect a 33% difference in median survival (hazard ratio [HR] < or = 0.75 for either of the experimental arms) with 81% power while maintaining a significance level of 2.5% in a two-sided test for each of the two primary comparisons.

resultsEight hundred thirty-two patients were enrolled. The median survival and 1-year survival were 4.9 months (95% CI, 4.5 to 5.6) and 16% for GEM, 6.2 months (95% CI, 5.4 to 6.9), and 21% for GEM FDR (HR, 0.83; stratified log-rank P = .04), and 5.7 months (95% CI, 4.9 to 6.5) and 21% for GEMOX (HR, 0.88; stratified log-rank P = .22). Neither of these differences met the prespecified criteria for significance. Survival was 9.2 months for patients with locally advanced disease, and 5.4 months for those with metastatic disease. Grade 3/4 neutropenia and thrombocytopenia were greatest with GEM FDR. GEMOX caused higher rates of nausea, vomiting, and neuropathy.

conclusionNeither GEM FDR nor GEMOX resulted in substantially improved survival or symptom benefit over standard GEM in patients with advanced pancreatic cancer.

Indexed as

AdultAgedAntimetabolites, AntineoplasticAntineoplastic Combined Chemotherapy ProtocolsDeoxycytidineDisease-Free SurvivalDrug Administration ScheduleFemaleGemcitabineHumansInfusions, IntravenousKaplan-Meier EstimateMaleMiddle AgedOrganoplatinum CompoundsOxaliplatinAntimetabolites, AntineoplasticDeoxycytidineGemcitabineOrganoplatinum CompoundsOxaliplatin

Identifiers

PMID19581537
PMCPMC2727286
OpenAlexW2014366767

What OpenQuestion holds

Textmetadata
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.