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RSHF in Colorectal Cancer (RS CAMPTO)

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ClinicalTrials.gov Identifier: NCT01220063
Recruitment Status : Completed
First Posted : October 13, 2010
Last Update Posted : January 7, 2019
Sponsor:
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment Phase
Metastatic Colorectal Cancer Radiation: Radiation Drug: Irinotecan Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
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
Actual Study Start Date : October 19, 2007
Actual Primary Completion Date : August 2018
Actual Study Completion Date : August 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Radiation + 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: Radiation
10 Gy for 4 times (total 40 Gy)
Other Name: RSHF

Drug: Irinotecan
40 mg/m² : Day 1 and day 8
Other Name: Campto




Primary Outcome Measures :
  1. tumor response accoording to recist criteria [ Time Frame: 5 years ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01220063


Locations
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France
Hôpital Saint André
Bordeaux, France, 33075
Centre Oscar Lambret
Lille, France, 59 000
Centre Léon Berard
Lyon, France, 69 000
Centre hospitalier Lyon Sud
Lyon, France, 69000
Hôpital la Source
Orléans, France, 45100
Centre René Gauducheau
Saint Herblain, France, 44805
Sponsors and Collaborators
Institut Cancerologie de l'Ouest
Investigators
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Study Director: RIO EMMANUEL, MD INSTITUT DE CANCEROLOGIE DE L'OUEST

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Responsible Party: Institut Cancerologie de l'Ouest
ClinicalTrials.gov Identifier: NCT01220063     History of Changes
Other Study ID Numbers: 06/9-R
First Posted: October 13, 2010    Key Record Dates
Last Update Posted: January 7, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Institut Cancerologie de l'Ouest:
RSHF
Irinotecan
Colorectal Cancer
metastases
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Irinotecan
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents