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

Adenocarcinoma of Rectum Clinical Trial

Official title: Phase II: First Line Treatment by FOLFIRINOX for Patients With a Rectum Cancer With Synchronous Non Resectable Metastasis

Status Completed

Clinical Trial 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).

Clinical Trial Description

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).

3. Inclusion and non inclusion criteria

4. Treatment

5. Follow up ;

Related Conditions & MeSH terms

• Adenocarcinoma
• Adenocarcinoma of Rectum
• Rectal Neoplasms

• NCT number: NCT01674309
• Study type: Interventional
• Source: Federation Francophone de Cancerologie Digestive
• Status: Completed
• Phase: Phase 2
• Start date: April 2012
• Completion date: October 2016