Multicenter Randomized Controlled Trial of Combination Antiemetic Therapy With Aprepitant / Fosaprepitant in Patients With Colorectal Cancer Receiving Oxaliplatin-based Chemotherapy
Inclusion Criteria:
- Age: ≥20 years old
- Sex: Not specified
- Patients with colon/rectal cancer who first underwent FOLFOX, XELOX or SOX regimen
including oxaliplatin at ≥85 mg/m2 (naive patient), or those who had already started
chemotherapy and had nausea of Grade 2 or higher in the last course or an earlier
course (non-naive patient).
- Stage: not specified (neoadjuvant/adjuvant chemotherapy, advanced or recurrent type
are allowed)
- Combination of molecular targeted therapy: allowable
- Written informed consent for participation in the study.
Exclusion Criteria:
- Severe liver or kidney disease
- Nausea/vomiting within 24 hr prior to chemotherapy.
- Treatment with antiemetics within 24 hr prior to chemotherapy.
- Presence of factors causing nausea/vomiting other than chemotherapy (e.g. brain
tumor, gastrointestinal obstruction, active peptic ulcer disease, brain metastasis)
- Presence of a disease precluding 3-day administration of dexamethasone (e.g.
uncontrollable diabetes)
- Pregnant or lactating women, women who plan to become pregnant.
- Current treatment with pimozide.
- Any patient judged to be inappropriate for the study by the investigator.