RSHF in Colorectal Cancer

Study Overview
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Brief Summary
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The purpose of this study is to study stereotactic radiotherapy with a dose of 40 Gy in 4 fractions over 2 weeks with concomitant 40 mg/m2 of irinotecan (1st and 3rd irradiation session).

Official Title
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CLINICAL MULTICENTER STUDY OF PHASE II AND RADIOBIOLOGY ASSESSING Hypofractionated Stereotactic Radiotherapy With Irinotecan (Campto) IN THE TREATMENT OF LIVER METASTASIS AND / OR PULMONARY, Unoperated or Recurrent After Surgery of a Colorectal Cancer

Conditions
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Metastatic Colorectal Cancer

Intervention / Treatment
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* Radiation: Radiation
* Drug: Irinotecan


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > or = 18 years Social Insurance Performance Index <2 Life expectancy> 6 months adenocarcinoma colorectal (histologically proven) Metastases (inoperable or recurrent after surgery), hepatic localization and / or lung (up to 3 if one organ metastasis or 3 in total if the two bodies are metastatic). The largest diameter of the metastasis will < ou = 6cm for the liver, < or = 6 cm for the lung. If multiple metastases, the sum of their maximum diameter is 6cm < ou = the liver, < ou = 6 cm for the lung. Lesion (s) measurable (s) and evaluable (s) CT less than 3 weeks Patients must have received at least one prior chemotherapy regimen containing 5FU • Patients may have received one or more lines of chemotherapy including irinotecan. bilirubin <1.5 x ULN AST and ALT <5x ULN neutrophils> 1.5x109 / L, platelets> 100x109 / L, hemoglobin> 9 g / dL TP, TCA Normal (only for patients treated with a permanent implant) Informed consent signed. Exclusion Criteria: contraindication to the administration of irinotecan. History of radiotherapy in the thoraco-abdominal-cons indicating further irradiation. History of other invasive cancer treated in a period of less than 5 years (basal cell carcinoma and non-invasive cervical excepted) Metastatic disease diffuse or more than three metastases in the liver and / or lung during the natural history of disease (excluding any patient is having a complete radiological response on several metastases although 1-3 residual after treatment ( s) medical (at)). Location (s) tumor (s) = CTV to less than 12 mm laterally or less than 15 mm in the cranio-caudal, stomach, small intestine, esophagus, trachea, bronchi of right and left pulmonary arteries and right and left. Pregnancy or breastfeeding. - Lack of means or refusal to use effective contraception for men or women of childbearing age. Any other concomitant experimental treatment. Any other concurrent anticancer therapy, immunotherapy or hormonal therapy. Monitoring impossible because of psychological, sociological or because of geographical distance.

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: Radiation + Irinotecan<br>Irinotecan will be administered : - 40 mg/m² in serum physiologique during 30 to 90 min at D1 and D8 of radiotherapy Radiotherapy (RSHF) will be administered : at D1, D3, D8 and D10 48 Gy, 12 Gy by fractions twice a week | Radiation: Radiation<br>* 10 Gy for 4 times (total 40 Gy)<br>* Other names: RSHF;Drug: Irinotecan<br>* 40 mg/m² : Day 1 and day 8<br>* Other names: Campto;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| tumor response accoording to recist criteria |  | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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RSHF, Irinotecan, Colorectal Cancer, metastases