Trials / Completed
CompletedNCT01344304
Study of Aprepitant / Fosaprepitant for the Prevention of Chemotherapy-induced Nausea and Vomiting (CINV) in Colorectal Cancer Patients - SENRI Trial
Multicenter Randomized Controlled Trial of Combination Antiemetic Therapy With Aprepitant / Fosaprepitant in Patients With Colorectal Cancer Receiving Oxaliplatin-based Chemotherapy
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 413 (actual)
- Sponsor
- Multicenter Clinical Study Group of Osaka, Colorectal Cancer Treatment Group · Academic / Other
- Sex
- All
- Age
- 20 Years
- Healthy volunteers
- Not accepted
Summary
The object of this study is to evaluate the superiority of aprepitant therapy with a 5HT3-receptor antagonist, dexamethasone and aprepitant compared to standard therapy with a 5HT3-receptor antagonist and dexamethasone for prevention of nausea and vomiting in first course chemotherapy.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Aprepitant / Fosaprepitant | Aprepitant: 125 mg PO on day 1 80 mg PO on days 2 to 3 Fosaprepitant: 150 mg IV on day 1 |
Timeline
- Start date
- 2011-04-01
- Primary completion
- 2013-11-01
- Completion
- 2015-04-01
- First posted
- 2011-04-29
- Last updated
- 2021-02-26
Locations
27 sites across 1 country: Japan
Source: ClinicalTrials.gov record NCT01344304. Inclusion in this directory is not an endorsement.