Evidence map›Paper›PMID 20837948›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2010

Adjuvant gemcitabine alone versus gemcitabine-based chemoradiotherapy after curative resection for pancreatic cancer: a randomized EORTC-40013-22012/FFCD-9203/GERCOR phase II study.

Jean-Luc Van Laethem, Pascal Hammel, Françoise Mornex, David Azria, Geertjan Van Tienhoven, Philippe Vergauwe, Marc Peeters, Marc Polus, Michel Praet, Murielle Mauer and 5 more

Registry-linked trialAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
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, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00064207 (Randomized Phase II/III Study Comparing Gemcitabine Followed by Gemcitabine Plus Concomitant Radiation), which is not on this map. Cited by 109 papers, 8 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
109citing papers in PubMed, 8 pooled it
–field-weighted citation impact
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.

NCT00064207 phase2 / phase3completednot on this map

Randomized Phase II/III Study Comparing Gemcitabine Followed by Gemcitabine Plus Concomitant Radiation (50.4 Gy) Versus Control After Curative Pancreaticoduodenectomy for Pancreatic Head Cancer

TypeinterventionalSponsorEuropean Organisation for Research and Treatment of Cancer - EORTCRan2003Enrolled97ConditionsPancreatic CancerArmsgemcitabine hydrochloride, adjuvant therapy, radiation therapy
3 · Its place in the literature

Who cites it

109 citing papers in PubMed, 8 syntheses or guidelines pooled it.

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

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

15 authors.

Jean-Luc Van LaethemDepartment of Gastroenterology, Erasme University Hospital, Université Libre de Bruxelles, Brussels, Belgium. JL.Vanlaethem@erasme.ulb.ac.be
Pascal Hammel
Françoise Mornex
David Azria
Geertjan Van Tienhoven
Philippe Vergauwe
Marc Peeters
Marc Polus
Michel Praet
Murielle Mauer
Laurence Collette
Volker Budach
Manfred Lutz
Eric Van Cutsem
Karin Haustermans

Funding

EORTC HEADQUARTERSU10CA011488 · NCI · EUROPEAN ORG/RES/TREATMENT/CANCER · PI LACOMBE, DENIS · 1985 to 2015
$6.6M
NCI NIH HHS 5U10 CA11488-30NCI NIH HHS 5U10 CA11488-31NCI NIH HHS 5U10 CA11488-32NCI NIH HHS 5U10 CA11488-33NCI NIH HHS 5U10 CA11488-34NCI NIH HHS 5U10 CA11488-35NCI NIH HHS 5U10 CA11488-36NCI NIH HHS 5U10 CA11488-37NCI NIH HHS 5U10 CA11488-38NCI NIH HHS 5U10 CA11488-39NCI NIH HHS 5U10 CA11488-40NCI NIH HHS U10 CA011488
6 · The paper itself

Abstract

purposeThe role of adjuvant chemoradiotherapy (CRT) in resectable pancreatic cancer is still debated. This randomized phase II intergroup study explores the feasibility and tolerability of a gemcitabine-based CRT regimen after R0 resection of pancreatic head cancer. PATIENTS AND

methodsWithin 8 weeks after surgery, patients were randomly assigned to receive either four cycles of gemcitabine (control arm) or gemcitabine for two cycles followed by weekly gemcitabine with concurrent radiation (50.4 Gy; CRT arm). The primary objective was to exclude a < 60% treatment completion and a > 40% rate of grade 4 hematologic or GI toxicity in the CRT arm with type I and II errors of 10%. Secondary end points were late toxicity, disease-free survival (DFS), and overall survival (OS).

resultsBetween September 2004 and January 2007, 90 patients were randomly assigned (45:45). Patient characteristics were similar in both arms. Treatment was completed per protocol by 86.7% and 73.3% (80% CI, 63.1% to 81.9%; 95% CI, 58.1% to 85.4%) in the control and CRT arms, respectively, and grade 4 toxicity was 0% and 4.7% (two of 43; 80% CI, 1.2% to 11.9%), respectively. In the CRT arm, three patients experienced grade 3-related late toxicity. Median DFS was 12 months in the CRT arm and 11 months in the control arm. Median OS was 24 months in both arms. First local recurrence was less frequent in the CRT arm (11% v 24%).

conclusionAdjuvant gemcitabine-based CRT is feasible, well-tolerated, and not deleterious; adding this treatment to full-dose adjuvant gemcitabine after resection of pancreatic cancer should be evaluated in a phase III trial.

Indexed as

AdultAgedAntimetabolites, AntineoplasticChemotherapy, AdjuvantCombined Modality TherapyDeoxycytidineDiarrheaDrug Administration ScheduleFatigueFeasibility StudiesFemaleGemcitabineHumansKaplan-Meier EstimateMaleMiddle AgedAntimetabolites, AntineoplasticDeoxycytidineGemcitabine

Identifiers

PMID20837948
PMCPMC2988636

What OpenQuestion holds

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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.