RSHF in Colorectal Cancer

• Status: Completed
• Trial end date: 2018-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Institut Cancerologie de l'Ouest
• Treatments: Irinotecan

Criteria

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.