Feasibility study of adjuvant chemotherapy with FOLFOX(or XELOX) for 3 months followed by oral anticancer drug for 3 months in patients with completely resected colorectal cancer
Phase 1
- Conditions
- Colorectal Cancer
- Registration Number
- JPRN-UMIN000004934
- Lead Sponsor
- PO Japan Southwest Oncology Research Support Organization(JSWOG)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 80
Inclusion Criteria
Not provided
Exclusion Criteria
1)a history of serious drug hypersensitivity or serious drug allergy. 2)active double cancer 3) women who are pregnant, lactating, or wish to become pregnant 4)a history of colorectal cancer 5)more than grade 1 (CTCAE v4.0) peripheral neuropathy 6)clinically significant heart disease 7) judged to be unsuitable for this trial due to clinically significant mental / psychological disease etc 8)clinically important infection or suspected infection in febrile patients. 9)diarrhea(watery) or diarrhea that interferes with daily activities for patients with a stoma. 10) dementia 11)diabetes with uncontrolled or accompanied neuropathy 12)judged to be ineligible by principal investigator for any other reason.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Frequency and Grade of peripheral neuropathy(CTCAE v4 and PNQ)
- Secondary Outcome Measures
Name Time Method 1)Proportion of completion in oxaliplatin base therapy 2)Proportion of completion in adjuvant chemotherapy 3)Disease free survival 4)Proportion of treatment selection 5)Adverse event 6)Compare FOLFOX to XELOX in efficacy or adverse event