RSHF in Colorectal Cancer
This trial is active, not recruiting.
|Condition||metastatic colorectal cancer|
|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|
|Bordeaux, France||Hôpital Saint André||no longer recruiting|
|Lille, France||Centre Oscar Lambret||no longer recruiting|
|Lyon, France||Centre Léon Berard||no longer recruiting|
|Lyon, France||Centre hospitalier Lyon Sud||no longer recruiting|
|Orléans, France||Hôpital la Source||no longer recruiting|
|Saint Herblain, France||Centre René Gauducheau||no longer recruiting|
|Endpoint classification||efficacy study|
|Intervention model||single group assignment|
tumor response accoording to recist criteria
time frame: 5 years
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.
|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|
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