Trial reportGut2010
Combination 5-fluorouracil, folinic acid and cisplatin (LV5FU2-CDDP) followed by gemcitabine or the reverse sequence in metastatic pancreatic cancer: final results of a randomised strategic phase III trial (FFCD 0301).
Trial report in Gut, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00303758 (Essai Randomise Comparant Deux Stategies De Chimiotherapie Dans Les Cancers Pancreatiques Avances), which is not on this map. Cited by 36 papers, 6 of them syntheses that pooled 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.
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.
Essai Randomise Comparant Deux Stategies De Chimiotherapie Dans Les Cancers Pancreatiques Avances: LV5FU2 Simplifie + Cisplatine Suivi de Gemcitabine, Versus Gemcitabine Suivi de LV5FU2 Simplifie + Cisplatine en Can de Progression
Who cites it
36 citing papers in PubMed, 6 syntheses or guidelines pooled it, 81 citations in OpenAlex.
- Chemotherapy and radiotherapy for advanced pancreatic cancer.The Cochrane database of systematic reviews · 2024Pooled it
- Variability of quality-of-life measurements and reporting in randomised controlled trials of pancreatic cancer: a systematic review.BMJ open · 2024Pooled it
- Efficacy of Cisplatin-Containing Chemotherapy Regimens in Patients of Pancreatic Ductal Adenocarcinoma: A Systematic Review and Meta-analysis.Journal of gastrointestinal cancer · 2024Pooled it
- Chemotherapy and radiotherapy for advanced pancreatic cancer.The Cochrane database of systematic reviews · 2018Pooled it
- Consensus statement on mandatory measurements in pancreatic cancer trials (COMM-PACT) for systemic treatment of unresectable disease.The Lancet. Oncology · 2018Pooled it
- Metastatic Pancreatic Cancer: American Society of Clinical Oncology Clinical Practice Guideline.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2016Guideline
- High Dose Parenteral Ascorbate Inhibited Pancreatic Cancer Growth and Metastasis: Mechanisms and a Phase I/IIa study.Scientific reports · 2017Trial
- Effect of FOLFIRINOX as second-line chemotherapy for metastatic pancreatic cancer after gemcitabine-based chemotherapy failure.Medicine · 2017Trial
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- Predictive and prognostic factors of efficacy of third-line chemotherapy in patients with unresectable pancreatic cancer: a cohort-based study.The oncologist · 2025Article
- IntratumoralPathogens (Basel, Switzerland) · 2024Review
- The Microbiome in Pancreatic Cancer-Implications for Diagnosis and Precision Bacteriophage Therapy for This Low Survival Disease.Frontiers in cellular and infection microbiology · 2022Review
- 5-Molecules (Basel, Switzerland) · 2021Article
- Systemic Therapy for Metastatic Pancreatic Cancer.Current treatment options in oncology · 2021Review
- Current Clinical Strategies of Pancreatic Cancer Treatment and Open Molecular Questions.International journal of molecular sciences · 2019Review
- Pancreatic cancer: challenges and opportunities.BMC medicine · 2018Article
- Current status and dilemma of second-line treatment in advanced pancreatic cancer: is there a silver lining?OncoTargets and therapy · 2018Review
- Evaluation of gemcitabine efficacy after the FOLFIRINOX regimen in patients with advanced pancreatic adenocarcinoma.Medicine · 2017Observational
Corrections and comments
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Authors and funding
16 authors at 13 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeGemcitabine is the standard chemotherapy for patients with metastatic pancreatic adenocarcinoma. Although the 5-fluorouracil (5FU), folinic acid and cisplatin combination (LV5FU2-CDDP) is an option, the optimal order of the regimens must be determined. The first strategic phase III trial comparing LV5FU2-CDDP followed by gemcitabine versus gemcitabine followed by LV5FU2-CDDP was conducted.
methodsPatients with metastatic pancreatic adenocarcinoma, performance status (PS) 0-2, without prior chemotherapy were randomly assigned (1:1) to receive either LV5FU2-CDDP followed by gemcitabine at disease progression or toxicity (Arm A), or the opposite sequence (Arm B). 202 patients had to be included and 170 deaths had to be observed to detect an expected improvement in median overall survival (OS) from 6.5 to 10 months in Arm A (two-sided α = 5% and β = 20%).
results202 patients were included (Arm A, 102; Arm B, 100). Median age, male/female ratio, PS 0-1 and previous surgery were similar in the two arms. After a median follow-up of 44 months, median OS in Arm A was 6.6 months versus 8.0 months in Arm B (p = 0.85). Median progression-free survival was similar between Arms A and B. More grade 3/4 toxicities were observed when LV5FU2-CDDP was administered as a first-line treatment compared with gemcitabine: 79% versus 64% (p = 0.018).
conclusionThis trial did not show any strategic advantage to using LV5FU2-CDDP as a first-line treatment and suggests that gemcitabine remains the standard first-line treatment. Sixty-one per cent of patients were able to receive a second line of chemotherapy.
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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.