Status:
COMPLETED
Sequential Versus Combination Chemotherapy in Advanced Colorectal Carcinoma
Lead Sponsor:
Dutch Colorectal Cancer Group
Collaborating Sponsors:
Koningin Wilhelmina Fonds
Sanofi
Conditions:
Advanced Colorectal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Primary objective:To assess the efficacy, defined as overall survival, of sequential versus combination chemotherapy for advanced colorectal cancer (CRC). Methodology Open, randomised multicenter pha...
Detailed Description
Objectives: Primary objective: To assess the efficacy, defined as overall survival, of sequential versus combination chemotherapy for advanced CRC. Secondary objectives are to assess: To assess Tum...
Eligibility Criteria
Inclusion
- Histology and staging disease
- Histologically proven CRC; advanced disease, not amenable to curative surgery;
- Of Note: In case of a single metastasis, histological or cytological proof of colorectal carcinoma should be obtained prior to randomisation.
- Measurable or evaluable disease; Serum CEA as the only parameter for disease activity is not allowed.
- General conditions
- Written informed consent;
- Age 18 years and above;
- WHO performance status 0-2;
- Adequate bone marrow function(WBC \> 3.0 x 109/L, platelets \> 100 x 109/L, Hb \> 6 mmol/L);
- Adequate hepatic function: total bilirubin \< 1. 5 x upper normal limit, ASAT and ALAT \< 3 x upper normal limits; in case of liver metastases \< 5 x upper normal limits
- Adequate renal function: creatinin \< 1. 5 x upper normal limits.
- Other - Expected adequacy of follow-up.
Exclusion
- General conditions
- Pregnancy or lactation;
- Patients (M/F) with reproductive potential not implementing adequate contraceptives measures.
- Prior or current history
- Prior chemotherapy for advanced disease; prior adjuvant chemotherapy is allowed provided that the last administration was given \> 6 months prior to randomisation.
- Serious concomitant diseases preventing the safe administration of chemotherapy or likely to interfere with the study assessments;
- Serious active infections;
- Inflammatory bowel disease or other diseases associated with chronic diarrhoea;
- Previous extensive irradiation of the pelvis or abdomen;
- Other malignancies in the past 5 years with the exception of adequately treated carcinoma in situ of the cervix or squamous or basal cell carcinoma of the skin.
- Concomitant treatments
- Concomitant (or within 4 weeks before randomisation) administration of any other experimental drug under investigation;
- Concurrent treatment with any other anti-cancer therapy.
Key Trial Info
Start Date :
January 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2006
Estimated Enrollment :
820 Patients enrolled
Trial Details
Trial ID
NCT00312000
Start Date
January 1 2003
End Date
December 1 2006
Last Update
September 8 2008
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