This trial is active, not recruiting.

Condition metastatic colorectal cancer
Treatments rshf, irinotécan
Phase phase 2
Sponsor Institut Cancerologie de l'Ouest
Start date October 2007
End date June 2018
Trial size 48 participants
Trial identifier NCT01220063, 06/9-R


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).

United States No locations recruiting
Other countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment

Primary Outcomes

tumor response accoording to recist criteria
time frame: 5 years

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title 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
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Institut Cancerologie de l'Ouest.