CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 127 enrolled
Drug / intervention
FOLFIRI.3 +1 moredrug
Likely dose
FOLFIRI.3 90 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.

Search/NCT02827201
NCT02827201Phase 2Completed
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Phase II Randomised Multicenter Trial Evaluating a Sequential Treatment With Nab-paclitaxel+Gemcitabine /FOLFIRI.3 vs Nab-paclitaxel + Gemcitabine in First Line Metastatic Pancreatic Cancer

Federation Francophone de Cancerologie Digestive·interventional·Posted Jul 11, 2016·Updated Jul 9, 2024

In Brief

A Phase 2 clinical trial evaluating FOLFIRI.3 and nab-paclitaxel+ gemcitabine for Metastatic Pancreatic Cancer. Completed, enrolled 127 participants across 37 sites.

Detailed Summary

The main objective of this trial is to evaluate every 2 months alternating nab-paclitaxel/gemcitabine and FOLFIRI.3 versus nab-paclitaxel + gemcitabine, regarding the progression of disease at 6 months.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMetastatic Pancreatic Cancer
CountriesFrance
CollaboratorsUNICANCER, GERCOR - Multidisciplinary Oncology Cooperative Group

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedJul 11, 2016
Enrollment StartNov 1, 2015
Primary CompletionDec 1, 2017
Study CompletionMar 1, 2021
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 10.0 years ago

Interventions

FOLFIRI.3drug

For each cycle : 1 week out of 2 - injection at Day1, J15 Irinotécan 90 mg/m² at day1 in perfusion over 60 min in Y of folinic acid Folinic Acid 400 mg/m² (or 200 mg/m² Elvorine) at Day 1 in perfusion over 2 hours 5FU continu 2000 mg/m² during 46 hours Irinotécan at 90 mg/m² in perfusion over 60 mn at Day 3 (when 5FU perfusion is over)

nab-paclitaxel+ gemcitabinedrug

For each cycle : 3 weeks out of 4 - injection at Day 1, 8 and 15 Nab-paclitaxel : 125 mg/m² of nab-paclitaxel in perfusion over 30 mn. Gemcitabine 1000 mg/m² in perfusion over 30 mn immediately after Nab paclitaxel administration is over.