|
Main
|
|
Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
17 October 2012 |
|
Main ID: |
NCT00126256 |
|
Date of registration:
|
02/08/2005 |
|
Primary sponsor: |
|
|
Public title:
|
Trial Comparing Two Strategies of Chemotherapy for Metastatic Colorectal Cancer
|
|
Scientific title:
|
Randomized Trial of Treatment Strategy for Chemotherapy in Colorectal Cancer, FFCD 2000-05 |
|
Date of first enrolment:
|
February 2002 |
|
Target sample size:
|
570 |
|
Recruitment status: |
Recruiting |
|
URL:
|
http://clinicaltrials.gov/show/NCT00126256 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
|
|
|
Countries of recruitment
|
|
France
| | | | | | | |
|
Contacts
|
|
Name:
|
Michel Ducreux, Pr |
|
Address:
|
|
|
Telephone:
|
00 33 014-211-4308 |
|
Email:
|
ducreux@igr.fr |
|
Affiliation:
|
|
|
|
Name:
|
Michel Ducreux, Pr |
|
Address:
|
|
|
Telephone:
|
00 33 014-211-4308 |
|
Email:
|
ducreux@igr.fr |
|
Affiliation:
|
|
|
|
Name:
|
Jean-Pierre F Pignon, MD, PhD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Institut Gustave Roussy |
|
|
Name:
|
Michel Ducreux, Pr |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Institut Gustave Roussy |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Histologically confirmed metastatic colorectal adenocarcinoma
- Unresectable metastasis
- Bidimensionally measurable disease (World Health Organization [WHO] criteria)
- WHO performance status of 2 or less
- Adequate hematologic functions (neutrophil count, at least 1500 per cubic millimeter;
and platelet count, at least 100,000 per cubic millimetre)
- Adequate renal function (serum creatinine, less than 125 micromol per liter)
- Adequate liver function (bilirubin, not more than 5 times the upper limit of normal)
- No previous chemotherapy other than previous adjuvant chemotherapy or concomitant
chemoradiotherapy with 5-fluorouracil and leucovorin for the treatment of the primary
tumor completed at least 6 months before inclusion
- Signed written inform consent
- Quality of life questionnaire (QLQ C-30) filled out
Exclusion Criteria:
- Pregnant or breast – feeding women
- Impossibility of regular follow-up for psychological, social or geographical reason
- Severe cardiac, respiratory, renal or hepatic failure
- Active coronary heart disease
- Patients with a history of a psychological illness or condition such as to interfere
with the patient’s ability to understand the requirements of the study
- Central nervous system metastases
- Past history of second malignancies
- Another investigational drug
- Chronic inflammatory bowel disease
- Previous chemotherapy with irinotecan or oxaliplatin based regimens
Age minimum:
N/A
Age maximum:
75 Years
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Colorectal Cancer
|
|
Metastasis
|
|
Intervention(s)
|
|
Drug: 5-fluorouracil
|
|
Drug: irinotecan
|
|
Drug: leucovorin
|
|
Drug: oxaliplatin
|
|
Primary Outcome(s)
|
|
Progression-free survival after two lines of chemotherapy, defined as the time duration from randomization until progression after two lines of chemotherapy or death whatever the cause in the absence of progression or last-follow-up
|
|
Secondary Outcome(s)
|
|
Costs
|
|
Overall survival
|
|
Progression-free survival after the first and the third line of chemotherapy
|
|
Quality of life
|
|
Response rate
|
|
Safety
|
|
Secondary surgery
|
|
Secondary ID(s)
|
|
CET 815
|
|
FFCD 2000 – 05
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|