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

Multicenter Clinical Study Group of Osaka, Colorectal Cancer Treatment Group

Status: Completed

Conditions: Colorectal Cancer

Treatments: Drug: Aprepitant / Fosaprepitant

Study type: Interventional

Funder types: Other

Identifiers

NCT01344304

SENRI

Details and patient eligibility

About

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.

Enrollment: 413 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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413 participants in 2 patient groups

Standard therapy

No Intervention group

Description:

The patients are treated with 5HT3-receptor antagonist + dexamethasone during the first course, then treated with aprepitant / fosaprepitant + 5HT3-receptor antagonist + dexamethasone

Aprepitant / Fosaprepitant therapy

Experimental group

Description:

The patients are treated with aprepitant / fosaprepitant + 5HT3-receptor antagonist + dexamethasone during first and second courses.

Treatment:

Drug: Aprepitant / Fosaprepitant