colorectal cancer
Conditions
Interventions
For aprepitant therapy Aprepitant
125 mg PO on day 1, 80 mg PO on days 2 to 3 5HT3-receptor antagonist
IV administration on day 1 Dexamethasone
6.6 mg IV on day 1, 4 mg PO on days 2 to 3 For fosaprepitant therapy Fosaprepitant
150 mg IV on day 1 5HT3-receptor antagonist
IV administration on day 1 Dexamethasone
6.6 mg IV on day 1, 4 mg PO on day 2 and 8mg PO on day 3
5HT3-receptor antagonist
9.9 mg IV on day 1, 8 mg PO on days 2 to 3
Sponsors
Multicenter Clinical Study Group of Osaka, Colorectal Cancer Treatment Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patient is 20 years and over 2) Patients with colon/rectal cancer who first underwent FOLFOX, XELOX or SOX regimen including oxaliplatin at 85 mg/m2 or more, or those who had already started chemotherapy and had nausea of Grade 2 or higher in the last course or an earlier course 3) Stage: not specified 4) Combination of molecular targeted therapy: allowable
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients with "No emesis" | — |
Countries
Japan
Contacts
Public ContactJunichi Nishimura
Osaka University (postgraduate course) Department of Gastroenterological Surgery
Outcome results
None listed