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Gemcitabine and Paclitaxel vs Gemcitabine Alone After FOLFIRINOX Failure in Metastatic Pancreatic Ductal Adenocarcinoma

NCT03943667 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 211

Last updated 2026-01-15

Study results available
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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.

Conditions

  • Metastatic Pancreatic Adenocarcinoma

Interventions

DRUG

Gemcitabine

1000 mg/m² in IV infusion over 30-40 minutes at Day 1, 8 and 15 followed by one week of rest.

DRUG

Paclitaxel

80 mg/m² in IV infusion over 60 minutes at Day 1, 8 and 15 followed by 1 week of rest.

Sponsors & Collaborators

  • UNICANCER

    lead OTHER

Principal Investigators

  • Christelle de la FOUCHARDIERE, Dr · UNICANCER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-23
Primary Completion
2022-04-26
Completion
2022-04-26

Countries

  • France

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03943667 on ClinicalTrials.gov