Randomized Phase II trial of Palonosetron/Dexamethasone concurrent therapy with prevention of CINV according to chemotherapy including Oxaliplatin or Irinotecan in patients with advanced colorectal cancer.
Phase 2
- Conditions
- advanced colorectal cancer
- Registration Number
- JPRN-UMIN000005534
- Lead Sponsor
- ara Hospital Kinki University Faculty of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 80
Inclusion Criteria
Not provided
Exclusion Criteria
(1) Severe complications (2) Obstraction of the gastric outlet or bowel (3) Symptomatic brain metastases (4) Massive pleural or abdominal effusion (5) Nervous tic (6) Hypersensitivity or severe drug allergy for 5-HT3RA (7) Hypersensitivity or severe drug allergy for dexamethasone. (8) Serious drug hypersensitivity (9) Emetic episodes or CTCAE grade 2< or = nausea (10) Women who are unwilling to avoid pregnancy. Women who are pregnant or breastfeeding. (11) Any other cases who are regarded as inadequate for study enrollmet by investigators
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method