Chemotherapy with Camptothecin-11 (CPT-11), Fluorouracil (5FU), folinic acid and oxaliplatin in patients with metastatic colorectal cancer
- Conditions
- Metastatic Colorectal CancerCancer - Bowel - Back passage (rectum) or large bowel (colon)
- Registration Number
- ACTRN12609000585224
- Lead Sponsor
- Hellenic Cooperative Oncology Group (HeCOG)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 314
INCUSION CRITERIA
Histologically confirmed metastatic adeno-carcinoma of the colon or rectum.
Measurable metastatic disease (at least one) bidimensionally measurable lesion [according to WHO (World Health Organization) criteria].
No potentailly resectable metastasis.
Patients should be over 18 years old.
WHO/ECOG (Eastern Cooperative Oncology Group) performance status 0-2.
No prior chemotherapy or only adjuvant chemotherapy ended more than 6 months before randomisation.
Adequate renal and liver function creatinine <= 1.5 x upper normal limits, Serum glutamic oxaloacetic transaminase (SGOT)/Serum glutamic pyruvic transaminase (SGPT) <=5 x upper normal limits).
Baseline neutrophil count > 1,500/iL and platelet count > 100,000/iL.
EXCLUSION CRITERIA
Pregnant or lactating patients.
Patients with reproductive potential who are not using adequate contraceptive measures.
Any prior chemotherapy for advanced disease. Adjuvant treatment ended within 6 months preceding study entry.
Central Nervous System (CNS) metastases, bone metastases or serosal effusions as the sole indicate of tumour.
Current history of chronic diarrhea.
Past or concurrent history of neoplasm other than colorectal adenocarcinoma, except for curatively treated non melanoma skin cancer or in situ carcinoma of the cervix.
Other serious illness (recent history of myocardial infarction, < 6 months).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Objective Response Rate (ORR). <br>The ORR will be assessed by imaging methods including computed tomography (CT) scan, bone scan, X-ray etc.[At 32 months from study initiation]
- Secondary Outcome Measures
Name Time Method Overall survival.[5 years from study initiation];Toxicity profile of both arms[1 month since the last administration of the drug. <br>Toxicity is assessed by laboratory evaluation of hematology and biochemistry, physical examination etc.];Progression free survival[5 years from study initiation]