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FOLFOX vs Gemcitabine in Patients With Metastatic Pancreatic Cancer Non-fit to FOLFIRINOX

NCT04167007 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2020-08-18

No results posted yet for this study

Summary

Pancreatic adenocarcinoma (PAC) incidence increases regularly in Western countries and it is expected to become the second leading cause of cancer-related mortality in 2020. The prognosis of this disease remains very poor with an overall 5-year survival rate less than 5%.

The FOLFIRINOX regimen (5-fluorouracil \[5-FU\], folinic acid, irinotecan, and oxaliplatin) and the combination of nab-paclitaxel with gemcitabine demonstrated to be more effective than gemcitabine alone, and are both validated as standard first-line treatment options for metastatic PAC. However, the use of FOLFIRINOX is limited to patients with ECOG performance status (PS) 0-1 and aged less than 75 years. Nab-paclitaxel is currently not reimbursed in France.

Conditions

  • Pancreatic Adenocarcinoma

Interventions

DRUG

Gemcitabine

Gemcitabine at 1000 mg/m² as intravenous (IV) infusion over 30-40 minutes on days 1, 8, and 15, followed by 1 week of rest, every 28 days

DRUG

FOLFOX

Oxaliplatin at 85 mg/m² given as a 2 hours IV infusion on days 1 and 15; Folinic acid 400 mg/m² (racemic form) or 200 mg/m² (L-form) in 250 ml glucose 5% solution given as a 2 hours IV infusion on days 1 and 15; and 5-FU 2400 mg/m² administered as continuous 46-hour IV infusion on days 1-3 and 15-17, every 28 days.

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Jean-Baptiste BACHET, MD, PhD · Assistance Publique - Hôpitaux de Paris

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-20
Primary Completion
2025-07-31
Completion
2025-07-31

Countries

  • France

Study Locations

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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 NCT04167007 on ClinicalTrials.gov