Status:
COMPLETED
RSHF in Colorectal Cancer
Lead Sponsor:
Institut Cancerologie de l'Ouest
Conditions:
Metastatic Colorectal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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).
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 19 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2018
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT01220063
Start Date
October 19 2007
End Date
August 1 2018
Last Update
January 7 2019
Active Locations (6)
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1
Hôpital Saint André
Bordeaux, France, 33075
2
Centre Oscar Lambret
Lille, France, 59 000
3
Centre Léon Berard
Lyon, France, 69 000
4
Centre hospitalier Lyon Sud
Lyon, France, 69000