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

Overview

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.

Full Title of Study: “Multicenter Randomized Controlled Trial of Combination Antiemetic Therapy With Aprepitant / Fosaprepitant in Patients With Colorectal Cancer Receiving Oxaliplatin-based Chemotherapy”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: November 2013

Interventions

  • 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

Arms, Groups and Cohorts

  • No Intervention: Standard therapy
    • 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
    • The patients are treated with aprepitant / fosaprepitant + 5HT3-receptor antagonist + dexamethasone during first and second courses.

Clinical Trial Outcome Measures

Primary Measures

  • Patient diary recording nausea, emesis, food ingestion, and rescue therapy
    • Time Frame: From initiating administration of anticancer agents to day 6 (120 hours)

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Multicenter Clinical Study Group of Osaka, Colorectal Cancer Treatment Group
  • Provider of Information About this Clinical Study
    • Sponsor

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