Phase II: First Line Treatment by FOLFIRINOX for Patients With a Rectum Cancer With Synchronous Non Resectable Metastasis
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
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Tumor control rate of the primary tumor and metastasis
The tumor control rate of the primary site and metastasis is defined as Complete response or Partial response or stability according to RECIST 1.1 criteria
4 months
No
Jean-Baptiste BACHET, Doctor
Principal Investigator
CHU de La Pitié Salpetrière - APHP
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
FFCD 1102
NCT01674309
April 2012
April 2016
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