RSHF in Colorectal Cancer (RS CAMPTO)

January 4, 2019 updated by: Institut Cancerologie de l'Ouest

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bordeaux, France, 33075
        • Hopital Saint André
      • Lille, France, 59 000
        • Centre Oscar Lambret
      • Lyon, France, 69 000
        • Centre Leon Berard
      • Lyon, France, 69000
        • Centre Hospitalier Lyon Sud
      • Orléans, France, 45100
        • Hopital La Source
      • Saint Herblain, France, 44805
        • Centre René Gauducheau

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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 Names:
  • RSHF
Drug: Irinotecan
40 mg/m² : Day 1 and day 8
Other Names:
  • Campto

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
tumor response accoording to recist criteria
Time Frame: 5 years
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Cancerologie de l'Ouest

Investigators

  • Study Director: RIO EMMANUEL, MD, Institut de Cancérologie de l'Ouest

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 19, 2007

Primary Completion (Actual)

August 1, 2018

Study Completion (Actual)

August 1, 2018

Study Registration Dates

First Submitted

October 11, 2010

First Submitted That Met QC Criteria

October 12, 2010

First Posted (Estimate)

October 13, 2010

Study Record Updates

Last Update Posted (Actual)

January 7, 2019

Last Update Submitted That Met QC Criteria

January 4, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 06/9-R

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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