RSHF in Colorectal Cancer (RS CAMPTO)

Institut Cancerologie de l'Ouest

Status and phase: Completed; Phase 2

Conditions: Metastatic Colorectal Cancer

Treatments: Radiation: Radiation; Drug: Irinotecan

Study type: Interventional

Funder types: Other

Identifiers

NCT01220063

06/9-R

Details and patient eligibility

About

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).

Enrollment: 48 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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48 participants in 1 patient group

Radiation + Irinotecan

Other group

Description:

Irinotecan will be administered : - 40 mg/m² in serum physiologique during 30 to 90 min at D1 and D8 of radiotherapy Radiotherapy (RSHF) will be administered : * at D1, D3, D8 and D10 * 48 Gy, 12 Gy by fractions twice a week

Treatment:

Drug: Irinotecan

Radiation: Radiation