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

Study Overview
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Brief Summary
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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. The main objective of the trial is to investigate the tumoral control rate at 4 months, according to the RECIST criteria (version 1.1). 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
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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. The main objective of the trial is to investigate the tumoral control rate at 4 months, according to the RECIST criteria (version 1.1). 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). Inclusion and non inclusion criteria Treatment Follow up

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

Conditions
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Adenocarcinoma of Rectum

Intervention / Treatment
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* Drug: FOLFORINOX


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: single arm study/ non randomized trial<br>FOLFORINOX | Drug: FOLFORINOX<br>* INTRAVENOUS administration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Toxicity of the treatment | Number of patients presenting the main toxicities during the study | 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) | 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 | 4 months | 
| survival without local failure (radiological or clinical progression of the rectal cancer or local complication) | The survival time is defined as the time between the patient's inclusion and the time of the local failure or patient's death | Up to 4 months after Last Patient First Visit | 
| rectal tumor response rate (CT scan, MRI and endocopy) | The rectal tumor response rate is the Complete response or the Partial response of the rectal tumor using RECIST 1.1 criteria | 4 months | 
| metastasis response rate | The metastasis tumor response rate is the Complete response or the Partial response of metastasis using RECIST 1.1 criteria | 4 months |