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

Phase 2

Completed

• Conditions: Adenocarcinoma of Rectum
• Interventions: Drug: FOLFORINOX

• Registration Number: NCT01674309
• Lead Sponsor: Federation Francophone de Cancerologie Digestive

Brief 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).

Detailed 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

Study Timeline

• Study Start: 2012-04
• Study First Submitted: 2012-04-02
• Study First Submitted QC: 2012-08-24
• Study First Posted: 2012-08-28
• Primary Completion: 2016-01
• Study Completion: 2016-10
• Status Verified: 2018-02
• Last Update Submitted: 2020-03-27
• Last Update Posted: 2020-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
single arm study/ non randomized trial	FOLFORINOX	FOLFORINOX

Primary Outcome Measures

Name	Time	Method
Tumor control rate of the primary tumor and metastasis	4 months	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

Secondary Outcome Measures

Name	Time	Method
metastasis response rate	4 months	The metastasis tumor response rate is the Complete response or the Partial response of metastasis using RECIST 1.1 criteria
Toxicity of the treatment	Up to 4 months after Last Patient First Visit	Number of patients presenting the main toxicities during the study
survival without local failure (radiological or clinical progression of the rectal cancer or local complication)	Up to 4 months after Last Patient First Visit	The survival time is defined as the time between the patient's inclusion and the time of the local failure or patient's death
rectal tumor response rate (CT scan, MRI and endocopy)	4 months	The rectal tumor response rate is the Complete response or the Partial response of the rectal tumor using RECIST 1.1 criteria
rate of local failure and local complication (occlusion, important bleedings, resistant pains with morphinic treatment, perforation)	4 months	The rate is defined as the clinical progression or a radiological progression of the rectum cancer or a local complication due to the treatment or due to the progression

Trial Locations

Locations (29)

CHU; 🇫🇷 Rouen, France

CH; 🇫🇷 Perpignan, France

Avicennes; 🇫🇷 Bobigny, France

CHU - Ht Lévêque; 🇫🇷 Bordeaux, France

Institut Bergonie; 🇫🇷 Bordeaux, France

CHU d'Estaing; 🇫🇷 Clermont Ferrand, France

Colmar Ch; 🇫🇷 Colmar, France

Centre G.F. Leclerc; 🇫🇷 Dijon, France

Polyclinique; 🇫🇷 Francheville, France

CHD Vendée; 🇫🇷 La Roche Sur Yon, France

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