Metastatic Colorectal Cancer
Conditions
Keywords
RSHF, Irinotecan, Colorectal Cancer, metastases
Brief 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).
Interventions
RADIATIONRadiation
10 Gy for 4 times (total 40 Gy)
DRUGIrinotecan
40 mg/m² : Day 1 and day 8
Sponsors
Institut Cancerologie de l'Ouest
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| tumor response accoording to recist criteria | 5 years |
Countries
France
Outcome results
None listed