MedTrace Logo

Trial Evaluating Modified FOLFIRINOX and Modified FOLFOX in the Treatment of Locally Advanced or Metastatic Small Bowel Adenocarcinoma

NCT06278545 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2024-02-26

No results posted yet for this study

Summary

Randomized, non-comparative, open-label, multi-centre Phase II study to evaluate modified FOLFIRINOX and modified FOLFOX in the locally advenced or metastatic small bowel adenocarcinoma.

The primary objective is to assess the percentage of patients alive without prograssion at 8 months.

Conditions

  • Locally Advanced or Metastatic Small Bowel Adenocarcinoma

Interventions

DRUG

modified FOLFORINOX

One treatment every 14 days : * Irinotecan 180mg/m² as a 2-hour IV infusion * Oxaliplatin 85 mg/m² as a 2-hour IV infusion * Folinic acid 400 mg/m² as 2-hour IV infusion, in Y with oxaliplatin * 5-FU 2400 mg/m² as a continuous IV infusion over 46 hours

DRUG

Modified FOLFOX

One treatment every 14 days: * Oxaliplatin 85 mg/m by IV infusion over 2 hours * Folinic acid: 400 mg/m² or 200 mg/m² if laevorotatory form by IV infusion over 2 hours, in Y with oxaliplatin * 5FU bolus: 400 mg/m² per 10-minute IV infusion * 5 FU continuous 2400 mg/m² by IV infusion over 46 hours

Sponsors & Collaborators

  • Centre Hospitalier Universitaire Dijon

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-16
Primary Completion
2027-02-28
Completion
2029-02-28

Countries

  • France

Study Locations

More Related Trials

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 NCT06278545 on ClinicalTrials.gov