Study of Aprepitant / Fosaprepitant for the Prevention of Chemotherapy-induced Nausea and Vomiting (CINV) in Colorectal Cancer Patients - SENRI Trial

Study Overview
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Brief Summary
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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.

Official Title
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Multicenter Randomized Controlled Trial of Combination Antiemetic Therapy With Aprepitant / Fosaprepitant in Patients With Colorectal Cancer Receiving Oxaliplatin-based Chemotherapy

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Drug: Aprepitant / Fosaprepitant


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard therapy<br>The patients are treated with 5HT3-receptor antagonist + dexamethasone during the first course, then treated with aprepitant / fosaprepitant + 5HT3-receptor antagonist + dexamethasone | |
| Experimental: Aprepitant / Fosaprepitant therapy<br>The patients are treated with aprepitant / fosaprepitant + 5HT3-receptor antagonist + dexamethasone during first and second courses. | Drug: Aprepitant / Fosaprepitant<br>* Aprepitant: 125 mg PO on day 1 80 mg PO on days 2 to 3 Fosaprepitant: 150 mg IV on day 1<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient diary recording nausea, emesis, food ingestion, and rescue therapy |  | From initiating administration of anticancer agents to day 6 (120 hours) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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aprepitant therapy, fosaprepitant therapy, 5HT3-receptor antagonist, dexamethasone, colorectal cancer, FOLFOX, XELOX, SOX