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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01344304

Enrollment

413

Registered

2011-04-29

Start date

2011-04-30

Completion date

2015-04-30

Last updated

2021-02-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer

Keywords

aprepitant therapy, fosaprepitant therapy, 5HT3-receptor antagonist, dexamethasone, colorectal cancer, FOLFOX, XELOX, SOX

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.

Interventions

DRUGAprepitant / Fosaprepitant

Aprepitant: 125 mg PO on day 1 80 mg PO on days 2 to 3 Fosaprepitant: 150 mg IV on day 1

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

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.

Design outcomes

Primary

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

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 27, 2026