Status:
SUSPENDED
IRIS Followed by mFOLFOX6 or the Reverse Sequence in Advanced Colorectal Cancer
Lead Sponsor:
Hokkaido Gastrointestinal Cancer Study Group
Collaborating Sponsors:
Hokkaido University Hospital
Conditions:
Metastatic Colorectal Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
This randomized phase III study compares safety and efficacy of two sequence arms in advanced colorectal cancer: irinotecan and S-1 (IRIS) followed by oxaliplatin containing regimen (arm A), or l-leuc...
Detailed Description
A multicenter randomized open-label controlled phase III study is conducted in patients with inoperable advanced or metastatic colorectal cancer who receive no previous chemotherapy. Usefulness of IRI...
Eligibility Criteria
Inclusion
- 1\. Histological diagnosis of colorectal cancer. 2） Age: 18 - 75 years. 3） No prior chemotherapy 4） ECOG Performance Status 0 to 2 5) A life expectancy of at least 3 months 6) Adequate function of major organs (bone marrow, heart, lungs, liver etc.). WBC ≧3,500/mm3 and Neutrophil ≧2,000/mm3. Hb ≧10.0 g/dl. Platelet count ≧100,000/mm3. AST and ALT ≦2.5 times the upper limit of normal (excluding liver metastasis). T-Bil ≦1.5 mg/dl. Creatinine ≦1.5 mg/ dl. 7).Patients must have the ability to understand and the willingness to sign a written informed contact document.
Exclusion
- Patients receiving blood transfusion, blood derivatives or granulocyte-colony stimulating factor within 7days prior to entering the study.
- Patients can not have oral intake
- Patients receiving Flucytosine treatment
- Patients with severe pleural effusion or ascites.
- Patients who have brown brain metastasis
- Patients with diarrhea 4 or more times per day
- Patients with active gastrointestinal bleeding.
- Patients with intestinal obstruction
- Patients with active infection.
- Patients with serious pulmonary disease (such as interstitial pneumonia, pulmonary fibrosis, pulmonary emphysema)
- Patients with serious complications (such as intestinal paralysis, intestinal obstruction, interstitial pneumonia or pulmonary fibrosis, uncontrolled diabetes mellitus, heart failure, renal failure, or hepatic failure).
- Patients with significant cardiac disease.
- Patients with active multiple cancer.
- Patients with neuropathy ≥ grade 2
- Patients who are pregnant, are of childbearing potential, or breast-feeding.
- Patients with severe mental disorder.
- Patients with a history of serious allergic reaction.
- Judged to be ineligible for this protocol by the investigation.
- \-
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2009
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00316745
Start Date
April 1 2006
End Date
March 1 2009
Last Update
November 1 2007
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Hokkaido University Hospital (Hokkaido University Graduate School of Medicine / School of Medicine)
Sapporo, Hokkaido, Japan, 060-8638