Overview

This trial is active, not recruiting.

Condition adenocarcinoma of rectum
Treatment folforinox
Phase phase 2
Sponsor Federation Francophone de Cancerologie Digestive
Start date April 2012
End date January 2016
Trial size 65 participants
Trial identifier NCT01674309, FFCD 1102

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Other)
FOLFORINOX
folforinox
INTRAVENOUS administration

Primary Outcomes

Measure
Tumor control rate of the primary tumor and metastasis
time frame: 4 months

Secondary Outcomes

Measure
Toxicity of the treatment
time frame: Up to 4 months after Last Patient First Visit
rate of local failure and local complication (occlusion, important bleedings, resistant pains with morphinic treatment, perforation)
time frame: 4 months
survival without local failure (radiological or clinical progression of the rectal cancer or local complication)
time frame: Up to 4 months after Last Patient First Visit
rectal tumor response rate (CT scan, MRI and endocopy)
time frame: 4 months
metastasis response rate
time frame: 4 months

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Histologically proven adenocarcinoma of the rectum, the lower pole less than 15 cm from the anal verge - Patient should not have receive any treatment for cancer - Synchronous metastases with unresectable hepatic and/or lung localization or uncertain resectability (potentially resectable) - Measurable lesions by RECIST 1.1 (metastasis and primary cancer of the rectum) - Age ≥ 18 years - WHO ≤ 2 - ANC ≥ 1.5 x 10 9/L, platelets ≥ 100 x 10 9/L, creatinine clearance ≥ 60 mL/min - Hemoglobin ≥ 10 g /dL - Signed informed consent Exclusion Criteria: - Rectal Cancer in occlusion requiring surgery or a prosthesis in emergency - Rectal bleeding severe and active - Prior pelvic irradiation - History of cancer, except non-melanoma skin cancer, carcinoma in situ of the cervix treated curatively and other cancers treated curatively if they do not relapse over 3 years, - Hepatic impairment (total bilirubin> 1.5 x upper limit of normal (ULN) and serum albumin <25g / L); known Gilbert's disease - Uncontrolled severe infection, - Severe pain (VAS> 5/10) uncontrollable by opioid therapy - Symptomatic sensorimotor peripheral neuropathy - Pregnant or lactating patients or patient of both sexes with childbearing potential and not using adequate contraception method - Patient receiving or having received an experimental therapy within 4 weeks prior to enter into the study or participating in another clinical study of other experimental drugs - Known hypersensitivity to any component of the treatment

Additional Information

Official title Phase II: First Line Treatment by FOLFIRINOX for Patients With a Rectum Cancer With Synchronous Non Resectable Metastasis
Principal investigator Jean-Baptiste BACHET, Dr
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
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Federation Francophone de Cancerologie Digestive.