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

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.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer
• Intervention / Treatment: Drug: Aprepitant / Fosaprepitant

• Study Type: Interventional
• Enrollment (Actual): 413
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Japan
  • Osaka, Japan, 5300001
    • Kenporen Osaka Central Hospital
  • Osaka, Japan, 5330022
    • Iseikai Hospital
  • Osaka, Japan, 5378511
    • Osaka Medical Center for Cancer and Cardiovascular Diseases
  • Osaka, Japan, 5400006
    • National Hospital Organization Osaka National Hospital
  • Osaka, Japan, 5430042
    • NTT WEST Osaka Hospital
  • Osaka, Japan, 5500012
    • Nissay Hospital
  • Osaka, Japan, 5500024
    • Tane General Hospital
  • Osaka, Japan, 5520021
    • Osaka Seninhoken Hospital
  • Osaka, Japan, 5530003
    • Osaka Koseinenkin Hospital
  • Osaka, Japan, 5588558
    • Osaka General Medical Center
  • Hyogo
    • Amagasaki, Hyogo, Japan, 6600064
      • Kansai Rosai Hospital
    • Itami, Hyogo, Japan, 6640872
      • Kinki Central Hospital
    • Kobe, Hyogo, Japan, 6520042
      • Kawasaki Hospital
  • Nara
    • Ikoma, Nara, Japan, 6300293
      • Nara Hospital Kinki University Faculty of Medicine
  • Osaka
    • Higashi-Osaka, Osaka, Japan, 5788588
      • Higashiosaka City General Hospital
    • Ibaraki, Osaka, Japan, 5670085
      • Saito Yukoukai Hospital
    • Izumisano, Osaka, Japan, 5988577
      • Rinku General Medical Center
    • Kaizuka, Osaka, Japan, 5970015
      • Kaizuka City Hospital
    • Matsubara, Osaka, Japan, 5800023
      • Hannan Chuo Hospital
    • Minoo, Osaka, Japan, 5620014
      • Minoh City Hospital
    • Sakai, Osaka, Japan, 5900064
      • Sakai City Hospital
    • Sakai, Osaka, Japan, 5918025
      • Osaka Rosai Hospital
    • Suita, Osaka, Japan, 5640082
      • Suita Municipal Hospital
    • Suita, Osaka, Japan, 5650862
      • Saiseikai Senri Hospital
    • Suita, Osaka, Japan
      • Graduate School of Medicine / Faculty of Medicine, Osaka University
    • Toyonaka, Osaka, Japan, 5608565
      • Toyonaka Municipal Hospital
    • Yao, Osaka, Japan, 5810069
      • Yao Municipal Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Multicenter Clinical Study Group of Osaka, Colorectal Cancer Treatment Group

Study record dates

Study Major Dates

• Study Start: April 1, 2011
• Primary Completion (Actual): November 1, 2013
• Study Completion (Actual): April 1, 2015

Study Registration Dates

• First Submitted: April 27, 2011
• First Submitted That Met QC Criteria: April 28, 2011
• First Posted (Estimate): April 29, 2011

Study Record Updates

• Last Update Posted (Actual): February 26, 2021
• Last Update Submitted That Met QC Criteria: February 25, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: colorectal cancer; dexamethasone; FOLFOX; SOX; XELOX; aprepitant therapy; fosaprepitant therapy; 5HT3-receptor antagonist
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Antiemetics; Gastrointestinal Agents; Neurokinin-1 Receptor Antagonists; Aprepitant; Fosaprepitant
• Other Study ID Numbers: SENRI