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

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01344304
• Other study ID #: SENRI
• Status: Completed
• Phase: N/A
• Start date: April 2011
• Est. completion date: April 2015

Study information

• Verified date: February 2021
• Source: Multicenter Clinical Study Group of Osaka, Colorectal Cancer Treatment Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 413
• Est. completion date: April 2015
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

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

Locations

Country	Name	City	State
Japan	Kansai Rosai Hospital	Amagasaki	Hyogo
Japan	Higashiosaka City General Hospital	Higashi-Osaka	Osaka
Japan	Saito Yukoukai Hospital	Ibaraki	Osaka
Japan	Nara Hospital Kinki University Faculty of Medicine	Ikoma	Nara
Japan	Kinki Central Hospital	Itami	Hyogo
Japan	Rinku General Medical Center	Izumisano	Osaka
Japan	Kaizuka City Hospital	Kaizuka	Osaka
Japan	Kawasaki Hospital	Kobe	Hyogo
Japan	Hannan Chuo Hospital	Matsubara	Osaka
Japan	Minoh City Hospital	Minoo	Osaka
Japan	Iseikai Hospital	Osaka
Japan	Kenporen Osaka Central Hospital	Osaka
Japan	National Hospital Organization Osaka National Hospital	Osaka
Japan	Nissay Hospital	Osaka
Japan	NTT West Osaka Hospital	Osaka
Japan	Osaka General Medical Center	Osaka
Japan	Osaka Koseinenkin Hospital	Osaka
Japan	Osaka Medical Center for Cancer and Cardiovascular Diseases	Osaka
Japan	Osaka Seninhoken Hospital	Osaka
Japan	Tane General Hospital	Osaka
Japan	Osaka Rosai Hospital	Sakai	Osaka
Japan	Sakai City Hospital	Sakai	Osaka
Japan	Graduate School of Medicine / Faculty of Medicine, Osaka University	Suita	Osaka
Japan	Saiseikai Senri Hospital	Suita	Osaka
Japan	Suita Municipal Hospital	Suita	Osaka
Japan	Toyonaka Municipal Hospital	Toyonaka	Osaka
Japan	Yao Municipal Hospital	Yao	Osaka

Sponsors (1)

Lead Sponsor	Collaborator
Multicenter Clinical Study Group of Osaka, Colorectal Cancer Treatment Group

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient diary recording nausea, emesis, food ingestion, and rescue therapy		From initiating administration of anticancer agents to day 6 (120 hours)