Clinical trial NCT01344304: Study of Aprepitant / Fosaprepitant for the Prevention of Chemotherapy-induced Nausea and Vomiting (CINV) in Colorectal Cancer Patients - SENRI Trial
Official title: Multicenter Randomized Controlled Trial of Combination Antiemetic Therapy With Aprepitant / Fosaprepitant in Patients With Colorectal Cancer Receiving Oxaliplatin-based Chemotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer
Keywords: aprepitant therapy
fosaprepitant therapy
5HT3-receptor antagonist
dexamethasone
colorectal cancer
FOLFOX
XELOX
SOX
Lead sponsor: Multicenter Clinical Study Group of Osaka, Colorectal Cancer Treatment Group
Sponsor class: OTHER
First posted: 2011-04-29
Enrollment: 413
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Patient diary recording nausea, emesis, food ingestion, and rescue therapy
timeFrame: From initiating administration of anticancer agents to day 6 (120 hours)
Secondary outcomes:
Other outcomes:
Locations:
city: Amagasaki
country: Japan
facility: Kansai Rosai Hospital
state: Hyogo
city: Itami
country: Japan
facility: Kinki Central Hospital
state: Hyogo
city: Kobe
country: Japan
facility: Kawasaki Hospital
state: Hyogo
city: Ikoma
country: Japan
facility: Nara Hospital Kinki University Faculty of Medicine
state: Nara
city: Higashi-Osaka
country: Japan
facility: Higashiosaka City General Hospital
state: Osaka
city: Ibaraki
country: Japan
facility: Saito Yukoukai Hospital
state: Osaka
city: Izumisano
country: Japan
facility: Rinku General Medical Center
state: Osaka
city: Kaizuka
country: Japan
facility: Kaizuka City Hospital
state: Osaka
city: Matsubara
country: Japan
facility: Hannan Chuo Hospital
state: Osaka
city: Minoo
country: Japan
facility: Minoh City Hospital
state: Osaka
city: Sakai
country: Japan
facility: Sakai City Hospital
state: Osaka
city: Sakai
country: Japan
facility: Osaka Rosai Hospital
state: Osaka
city: Suita
country: Japan
facility: Suita Municipal Hospital
state: Osaka
city: Suita
country: Japan
facility: Saiseikai Senri Hospital
state: Osaka
city: Suita
country: Japan
facility: Graduate School of Medicine / Faculty of Medicine, Osaka University
state: Osaka
city: Toyonaka
country: Japan
facility: Toyonaka Municipal Hospital
state: Osaka
city: Yao
country: Japan
facility: Yao Municipal Hospital
state: Osaka
city: Osaka
country: Japan
facility: Kenporen Osaka Central Hospital
city: Osaka
country: Japan
facility: Iseikai Hospital
city: Osaka
country: Japan
facility: Osaka Medical Center for Cancer and Cardiovascular Diseases
city: Osaka
country: Japan
facility: National Hospital Organization Osaka National Hospital
city: Osaka
country: Japan
facility: NTT West Osaka Hospital
city: Osaka
country: Japan
facility: Nissay Hospital
city: Osaka
country: Japan
facility: Tane General Hospital
city: Osaka
country: Japan
facility: Osaka Seninhoken Hospital
city: Osaka
country: Japan
facility: Osaka Koseinenkin Hospital
city: Osaka
country: Japan
facility: Osaka General Medical Center
Study officials:
References: