RSHF in Colorectal Cancer

Metastatic Colorectal Cancer Clinical Trial

— RS CAMPTO  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01220063
• Other study ID #: 06/9-R
• Status: Completed
• Phase: Phase 2
• Start date: October 19, 2007
• Est. completion date: August 2018

Study information

• Verified date: January 2019
• Source: Institut Cancerologie de l'Ouest
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: August 2018
• Est. primary completion date: August 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Metastatic Colorectal Cancer

Intervention

Radiation:
• Radiation
10 Gy for 4 times (total 40 Gy)

Drug:
• Irinotecan
40 mg/m² : Day 1 and day 8

Locations

Country	Name	City	State
France	Hôpital Saint André	Bordeaux
France	Centre Oscar Lambret	Lille
France	Centre hospitalier Lyon Sud	Lyon
France	Centre Léon Berard	Lyon
France	Hôpital la Source	Orléans
France	Centre René Gauducheau	Saint Herblain

Sponsors (1)

Lead Sponsor	Collaborator
Institut Cancerologie de l'Ouest

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	tumor response accoording to recist criteria		5 years