Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2009
Phase III randomized comparison of gemcitabine versus gemcitabine plus capecitabine in patients with advanced pancreatic cancer.
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. It is linked to trial NCT00032175 (A Phase III Multicenter Randomized Clinical Trial Comparing Gemcitabine Alone Or In Combination With Capecitabine For The Treatment Of Patients With Advanced Pancreatic Cancer), which is not on this map. Cited by 335 papers, 19 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.
A Phase III Multicenter Randomized Clinical Trial Comparing Gemcitabine Alone Or In Combination With Capecitabine For The Treatment Of Patients With Advanced Pancreatic Cancer
Who cites it
335 citing papers in PubMed, 19 syntheses or guidelines pooled it, 816 citations in OpenAlex.
- Necroptosis in pancreatic cancer: Molecular mechanisms and therapeutic implications.Apoptosis : an international journal on programmed cell death · 2026Pooled it
- Pan-Asian adapted ESMO Clinical Practice Guidelines for the diagnosis, treatment and follow-up of patients with pancreatic cancer.ESMO open · 2025Guideline
- 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
- Comparative Outcomes of First-Line Chemotherapy for Metastatic Pancreatic Cancer Among the Regimens Used in Japan: A Systematic Review and Network Meta-analysis.JAMA network open · 2022Pooled it
- Pooled it
- Modulation of pancreatic cancer cell sensitivity to FOLFIRINOX through microRNA-mediated regulation of DNA damage.Nature communications · 2021Pooled it
- The benefits of modified FOLFIRINOX for advanced pancreatic cancer and its induced adverse events: a systematic review and meta-analysis.Scientific reports · 2018Pooled it
- Chemotherapy and radiotherapy for advanced pancreatic cancer.The Cochrane database of systematic reviews · 2018Pooled it
- Clinical Factors as a Component of the Personalized Treatment Approach to Advanced Pancreatic Cancer: a Systematic Literature Review.Journal of gastrointestinal cancer · 2018Pooled it
- Consensus statement on mandatory measurements in pancreatic cancer trials (COMM-PACT) for systemic treatment of unresectable disease.The Lancet. Oncology · 2018Pooled it
- Combination therapy versus gemcitabine monotherapy in the treatment of elderly pancreatic cancer: a meta-analysis of randomized controlled trials.Drug design, development and therapy · 2018Pooled it
- Gemcitabine in Combination with a Second Cytotoxic Agent in the First-Line Treatment of Locally Advanced or Metastatic Pancreatic Cancer: a Systematic Review and Meta-Analysis.Targeted oncology · 2017Pooled it
- Pooled it
- Survival of patients with advanced pancreatic cancer after iodine125 seeds implantation brachytherapy: A meta-analysis.Medicine · 2017Pooled 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
- Gemcitabine plus cisplatin versus gemcitabine alone in the treatment of pancreatic cancer: a meta-analysis.World journal of surgical oncology · 2016Pooled it
- Efficacy and safety of gemcitabine plus erlotinib for locally advanced or metastatic pancreatic cancer: a systematic review and meta-analysis.Drug design, development and therapy · 2016Pooled it
- Saudi Oncology Society clinical management guideline series. Pancreatic cancer 2014.Saudi medical journal · 2014Guideline
- Phase I/II Study of Refametinib (BAY 86-9766) in Combination with Gemcitabine in Advanced Pancreatic cancer.Targeted oncology · 2017Trial
275 more citing papers are in PubMed but not listed here.
Corrections and comments
- Commented on by
Authors and funding
20 authors at 1 institution in 1 country.
Funding
Abstract
purposeBoth gemcitabine (GEM) and fluoropyrimidines are valuable treatment for advanced pancreatic cancer. This open-label study was designed to compare the overall survival (OS) of patients randomly assigned to GEM alone or GEM plus capecitabine (GEM-CAP). PATIENTS AND
methodsPatients with previously untreated histologically or cytologically proven locally advanced or metastatic carcinoma of the pancreas with a performance status <or= 2 were recruited. Patients were randomly assigned to GEM or GEM-CAP. The primary outcome measure was survival. Meta-analysis of published studies was also conducted.
resultsBetween May 2002 and January 2005, 533 patients were randomly assigned to GEM (n = 266) and GEM-CAP (n = 267) arms. GEM-CAP significantly improved objective response rate (19.1% v 12.4%; P = .034) and progression-free survival (hazard ratio [HR], 0.78; 95% CI, 0.66 to 0.93; P = .004) and was associated with a trend toward improved OS (HR, 0.86; 95% CI, 0.72 to 1.02; P = .08) compared with GEM alone. This trend for OS benefit for GEM-CAP was consistent across different prognostic subgroups according to baseline stratification factors (stage and performance status) and remained after adjusting for these stratification factors (P = .077). Moreover, the meta-analysis of two additional studies involving 935 patients showed a significant survival benefit in favor of GEM-CAP (HR, 0.86; 95% CI, 0.75 to 0.98; P = .02) with no intertrial heterogeneity.
conclusionOn the basis of our trial and the meta-analysis, GEM-CAP should be considered as one of the standard first-line options in locally advanced and metastatic pancreatic cancer.
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What OpenQuestion holds
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.