Phase II study of using Carbamazepine for neurosensory toxicity related FOLFOX regimens in patients with advanced/recurrent colorectal cancer (OGSG 0603)
Not Applicable
- Conditions
- advanced/recurrent colon cancer or rectal cancer
- Registration Number
- JPRN-UMIN000000718
- Lead Sponsor
- OGSG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 35
Inclusion Criteria
Not provided
Exclusion Criteria
(1) Patients who received transfusion, blood components or GCSF within seven days Before registration (2) with brain metastasis (3) with much cavity fluid to be removed (4) with active double cancer (5) allergy against medicines (6) uncontrolled Hypertension (7) receiving digitalis (8) uncontrolled DM (9) active infectious disease (10) watery diarrhea (11) disorder on EKG (12) severe respiratory diseases (interstitial pneumonitis, pulmonary fibrosis, Severe pulmonary emphysema) (13) psychiatric disorder (14) fresh bleeding on the digestive tract (15) sensory nerve disorder (16) pregnant and/or nursing women (17) driving a complicated mechanism or vehicle (18) Doctors' stop not to be registered
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To test the feasibility of Carmazepin therapy and to evaluate whether Carmazepin has the protective and/or prophylactic effects against peripheral nerve syndrome due to FOLFOX therapy
- Secondary Outcome Measures
Name Time Method Median dose of L-OHP, nerve disorder at the end of FOLFOX, Course, PFS and TTF, Response Rate