Clinical trial NCT01220063: RSHF in Colorectal Cancer
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Metastatic Colorectal Cancer
Keywords: RSHF
Irinotecan
Colorectal Cancer
metastases
Lead sponsor: Institut Cancerologie de l'Ouest
Sponsor class: OTHER
First posted: 2010-10-13
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.

Primary outcomes:
measure: tumor response accoording to recist criteria
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Hôpital Saint André
city: Lille
country: France
facility: Centre Oscar Lambret
city: Lyon
country: France
facility: Centre Léon Berard
city: Lyon
country: France
facility: Centre hospitalier Lyon Sud
city: Orléans
country: France
facility: Hôpital la Source
city: Saint Herblain
country: France
facility: Centre René Gauducheau
Study officials:
affiliation: INSTITUT DE CANCEROLOGIE DE L'OUEST
name: RIO EMMANUEL, MD
role: STUDY_DIRECTOR
References: