Sequential Versus Combination Chemotherapy in Advanced Colorectal Carcinoma
Advanced Colorectal Cancer
About this trial
This is an interventional treatment trial for Advanced Colorectal Cancer focused on measuring colorectal, cancer, capecitabine, irinotecan, oxaliplatin
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
1Capecitabine-irinotecan
2capecitabine plus irinotecan
1st line- 2nd line (3rd line oxaliplatin plus capecitabine)
1st line (2nd line oxaliplatin plus capecitabine)