search
Back to results

RSHF in Colorectal Cancer (RS CAMPTO)

Primary Purpose

Metastatic Colorectal Cancer

Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Radiation
Irinotecan
Sponsored by
Institut Cancerologie de l'Ouest
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Colorectal Cancer focused on measuring RSHF, Irinotecan, Colorectal Cancer, metastases

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hôpital Saint André
  • Centre Oscar Lambret
  • Centre Léon Berard
  • Centre hospitalier Lyon Sud
  • Hôpital la Source
  • Centre René Gauducheau

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Radiation + Irinotecan

Arm Description

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

Outcomes

Primary Outcome Measures

tumor response accoording to recist criteria

Secondary Outcome Measures

Full Information

First Posted
October 11, 2010
Last Updated
January 4, 2019
Sponsor
Institut Cancerologie de l'Ouest
search

1. Study Identification

Unique Protocol Identification Number
NCT01220063
Brief Title
RSHF in Colorectal Cancer
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
October 19, 2007 (Actual)
Primary Completion Date
August 2018 (Actual)
Study Completion Date
August 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Cancerologie de l'Ouest

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Colorectal Cancer
Keywords
RSHF, Irinotecan, Colorectal Cancer, metastases

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Radiation + Irinotecan
Arm Type
Other
Arm Description
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
Intervention Type
Radiation
Intervention Name(s)
Radiation
Other Intervention Name(s)
RSHF
Intervention Description
10 Gy for 4 times (total 40 Gy)
Intervention Type
Drug
Intervention Name(s)
Irinotecan
Other Intervention Name(s)
Campto
Intervention Description
40 mg/m² : Day 1 and day 8
Primary Outcome Measure Information:
Title
tumor response accoording to recist criteria
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
RIO EMMANUEL, MD
Organizational Affiliation
INSTITUT DE CANCEROLOGIE DE L'OUEST
Official's Role
Study Director
Facility Information:
Facility Name
Hôpital Saint André
City
Bordeaux
ZIP/Postal Code
33075
Country
France
Facility Name
Centre Oscar Lambret
City
Lille
ZIP/Postal Code
59 000
Country
France
Facility Name
Centre Léon Berard
City
Lyon
ZIP/Postal Code
69 000
Country
France
Facility Name
Centre hospitalier Lyon Sud
City
Lyon
ZIP/Postal Code
69000
Country
France
Facility Name
Hôpital la Source
City
Orléans
ZIP/Postal Code
45100
Country
France
Facility Name
Centre René Gauducheau
City
Saint Herblain
ZIP/Postal Code
44805
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

RSHF in Colorectal Cancer

We'll reach out to this number within 24 hrs