RSHF in Colorectal Cancer

Phase 2

Completed

• Conditions: Metastatic Colorectal Cancer
• Interventions: Radiation: Radiation; Drug: Irinotecan

• Registration Number: NCT01220063
• Lead Sponsor: Institut Cancerologie de l'Ouest

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).

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2007-10-19
• Study First Submitted: 2010-10-11
• Study First Submitted QC: 2010-10-12
• Study First Posted: 2010-10-13
• Primary Completion: 2018-08
• Study Completion: 2018-08
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-04
• Last Update Posted: 2019-01-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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.

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Radiation + Irinotecan	Irinotecan	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
Radiation + Irinotecan	Radiation	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

Primary Outcome Measures

Name	Time	Method
tumor response accoording to recist criteria	5 years

Trial Locations

Locations (6)

Centre Oscar Lambret; 🇫🇷 Lille, France

Centre hospitalier Lyon Sud; 🇫🇷 Lyon, France

Hôpital la Source; 🇫🇷 Orléans, France

Hôpital Saint André; 🇫🇷 Bordeaux, France

Centre René Gauducheau; 🇫🇷 Saint Herblain, France

Centre Léon Berard; 🇫🇷 Lyon, France