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

Not Applicable

Completed

• Conditions: Colorectal Cancer
• Interventions: Drug: Aprepitant / Fosaprepitant

• Registration Number: NCT01344304
• Lead Sponsor: Multicenter Clinical Study Group of Osaka, Colorectal Cancer Treatment Group

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-04
• Study First Submitted: 2011-04-27
• Study First Submitted QC: 2011-04-28
• Study First Posted: 2011-04-29
• Primary Completion: 2013-11
• Study Completion: 2015-04
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-25
• Last Update Posted: 2021-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 413

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Aprepitant / Fosaprepitant therapy	Aprepitant / Fosaprepitant	The patients are treated with aprepitant / fosaprepitant + 5HT3-receptor antagonist + dexamethasone during first and second courses.

Primary Outcome Measures

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

Trial Locations

Locations (27)

Kansai Rosai Hospital; 🇯🇵 Amagasaki, Hyogo, Japan

Kinki Central Hospital; 🇯🇵 Itami, Hyogo, Japan

Kawasaki Hospital; 🇯🇵 Kobe, Hyogo, Japan

Nara Hospital Kinki University Faculty of Medicine; 🇯🇵 Ikoma, Nara, Japan

Higashiosaka City General Hospital; 🇯🇵 Higashi-Osaka, Osaka, Japan

Saito Yukoukai Hospital; 🇯🇵 Ibaraki, Osaka, Japan

Rinku General Medical Center; 🇯🇵 Izumisano, Osaka, Japan

Kaizuka City Hospital; 🇯🇵 Kaizuka, Osaka, Japan

Hannan Chuo Hospital; 🇯🇵 Matsubara, Osaka, Japan

Minoh City Hospital; 🇯🇵 Minoo, Osaka, Japan

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