RSHF in Colorectal Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2010 by Centre René Gauducheau.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Centre René Gauducheau
ClinicalTrials.gov Identifier:
NCT01220063
First received: October 11, 2010
Last updated: October 12, 2010
Last verified: October 2010
  Purpose

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).


Condition Intervention Phase
Metastatic Colorectal Cancer
Radiation: RSHF
Drug: irinotécan
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Centre René Gauducheau:

Primary Outcome Measures:
  • tumor response accoording to recist criteria [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 48
Study Start Date: October 2007
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Radiation: RSHF
    10 Gy for 4 times (total 40 Gy)
    Drug: irinotécan
    40 mg/m² : Day 1 and day 8
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01220063

Locations
France
Hôpital Saint André Recruiting
Bordeaux, France, 33075
Contact: Véronique Vendrely, MD    + 33 5 56 79 56 79      
Principal Investigator: Véronique Vendrely, MD         
Centre Oscar Lambret Recruiting
Lille, France, 59 000
Contact: Xavier Mirabel, MD    +33 3 20 29 59 59      
Principal Investigator: Xavier Mirabel, MD         
Centre hospitalier Lyon Sud Not yet recruiting
Lyon, France, 69000
Contact: Françoise Mornex, MD         
Principal Investigator: Françoise Mornex, MD         
Centre Léon Berard Recruiting
Lyon, France, 69 000
Contact: Christian Carrie, MD    +33 4 78 78 28 28      
Sub-Investigator: Chirtian Carrie, MD         
Sub-Investigator: Claude Line, MD         
Principal Investigator: Isabelle Martel Lafay, MD         
Hôpital la Source Active, not recruiting
Orléans, France, 45100
Centre René Gauducheau Recruiting
Saint Herblain, France, 44805
Contact: Emmanuel Rio, MD    +33240679900      
Sponsors and Collaborators
Centre René Gauducheau
  More Information

No publications provided

Responsible Party: Mme Scotet-Cérato, Centre René Gauducheau
ClinicalTrials.gov Identifier: NCT01220063     History of Changes
Other Study ID Numbers: 06/9-R
Study First Received: October 11, 2010
Last Updated: October 12, 2010
Health Authority: France : Afssaps

Keywords provided by Centre René Gauducheau:
RSHF
Irinotecan
Colorectal Cancer
metastases

Additional relevant MeSH terms:
Colorectal Neoplasms
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms
Neoplasms by Site
Rectal Diseases
Irinotecan
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Radiation-Sensitizing Agents
Therapeutic Uses
Topoisomerase I Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on October 23, 2014