At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 211 enrolled
Drug / intervention
Gemcitabine +1 moredrug
Likely dose
Gemcitabine 1000 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase III Randomized Study Evaluating Gemcitabine and Paclitaxel Versus Gemcitabine Alone After FOLFIRINOX Failure or Intolerance in Metastatic Pancreatic Ductal Adenocarcinoma
In Brief
A Phase 3 clinical trial evaluating Gemcitabine and Paclitaxel for Metastatic Pancreatic Adenocarcinoma. Completed, enrolled 211 participants across 26 sites.
Detailed Summary
This study aims to evaluate whether the combination of gemcitabine and paclitaxel allows to improve the overall survival compared to gemcitabine alone, in patients with metastatic Pancreatic Ductal Adenocarcinoma (PDAC) after FOLFIRINOX failure or intolerance.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMetastatic Pancreatic Adenocarcinoma
CountriesFrance
Collaborators--
Timeline
Phase 3CompletedFinished
2020202120222023202420252026
First PostedMay 2019
Enrollment StartMay 2019
Primary CompletionApr 2022
TodayJul 2026
First PostedMay 9, 2019
Enrollment StartMay 23, 2019
Primary CompletionApr 26, 2022
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 7.1 years ago
Interventions
Gemcitabinedrug
1000 mg/m² in IV infusion over 30-40 minutes at Day 1, 8 and 15 followed by one week of rest.
Paclitaxeldrug
80 mg/m² in IV infusion over 60 minutes at Day 1, 8 and 15 followed by 1 week of rest.