Multicenter Randomized Controlled Trial of Combination Antiemetic Therapy with Aprepitant/Fosaprepitant in Patients with Colorectal Cancer Receiving Oxaliplatin-based chemotherapy
- Conditions
- colorectal cancer
- Registration Number
- JPRN-UMIN000005431
- Lead Sponsor
- Multicenter Clinical Study Group of Osaka, Colorectal Cancer Treatment Group
- Brief Summary
Combination antiemetic therapy with aprepitant/fosaprepitant in patients with colorectal cancer receiving oxaliplatin-based chemotherapy (SENRI trial): a multicentre, randomised, controlled phase 3 trial. Eur J Cancer. 2015 Jul;51(10):1274-82. Combination antiemetic therapy with aprepitant/fosaprepitant in patients with colorectal cancer receiving oxaliplatin-based chemotherapy in the SENRI trial: analysis of risk factors for vomiting and nausea. Int J Clin Oncol 2017;22(1):88-95.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 413
Not provided
1) Patient has a serious hepatic insufficiency or renal failure 2) Patient has nausea or vomiting within 24 hours prior to chemotherapy 3) Patient has been treated with antiemetic agents within 48 hours prior to chemotherapy 4) Patient has any illness (e.g. central nervous system tumors, gastrointestinal obstruction, active peptic ulcer, brain metastasis) caused nausea or vomiting except for chemotherapy-induced nausea and vomiting 5) Patient is unable to be administered dexamethasone for 3 days due to associated illnesses such as out-of-control diabetes mellitus 6) Patient is pregnant or lactating woman, and woman who plans to become pregnant 7) Patient is receiving treatment with pimozide 8) Patient is judged inappropriate by the investigator as subject for this study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of patients with "No emesis"
- Secondary Outcome Measures
Name Time Method