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
About this trial
This is an interventional treatment trial for Metastatic Colorectal Cancer focused on measuring RSHF, Irinotecan, Colorectal Cancer, metastases
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.
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
NCT ID
NCT01220063
First Posted
October 11, 2010
Last Updated
January 4, 2019
Sponsor
Institut Cancerologie de l'Ouest
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
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