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First Line Treatment by FOLFIRINOX for Patients With a Rectum Cancer With Synchronous Non Resectable Metastasis

NCT01674309 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2020-03-30

No results posted yet for this study

Summary

The FOLFIRINOX protocol seems a promising protocol as attack treatment of a rectum cancer, with an objective response rate of about 70 %. This phase II is to investigate if this systematic attack chemotherapy could control at the same time the rectal tumor and the synchronous metastasis without compromising secondarily the tumor or the metastasis resection or a radiochemotherapy administration.

1. The main objective of the trial is to investigate the tumoral control rate at 4 months, according to the RECIST criteria (version 1.1).
2. The secondary objectives are:

* safety of the treament,
* rate of local failure and local complication (occlusion, important bleedings, resistant pains with morphinic treatment, perforation),
* survival without local failure (radiological or clinical progression of the rectal cancer or local complication),
* rectal tumor response rate (CT scan, MRI and endocopy),
* metastasis response rate,
* disease free survival after complete resection (of primitive tumor and metastases),
* progression free survival (local or distal),
* overall survival, quality of life (QLQ-C30 + CR 29).

Conditions

  • Adenocarcinoma of Rectum

Interventions

DRUG

FOLFORINOX

INTRAVENOUS administration

Sponsors & Collaborators

  • Federation Francophone de Cancerologie Digestive

    lead OTHER

Principal Investigators

  • Jean-Baptiste BACHET, Dr · CHU de La Pitié Salpetrière - APHP

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-04-30
Primary Completion
2016-01-31
Completion
2016-10-31

Countries

  • France

Study Locations

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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 NCT01674309 on ClinicalTrials.gov