Study of Aprepitant / Fosaprepitant for the Prevention of Chemotherapy-induced Nausea and Vomiting (CINV) in Colorectal Cancer Patients - SENRI Trial
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 413
- 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.
- 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)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (27)
Saito Yukoukai Hospital
🇯🇵Ibaraki, Osaka, Japan
Hannan Chuo Hospital
🇯🇵Matsubara, Osaka, Japan
Suita Municipal Hospital
🇯🇵Suita, Osaka, Japan
Toyonaka Municipal Hospital
🇯🇵Toyonaka, Osaka, Japan
Osaka Seninhoken Hospital
🇯🇵Osaka, Japan
Higashiosaka City General Hospital
🇯🇵Higashi-Osaka, Osaka, Japan
Kaizuka City Hospital
🇯🇵Kaizuka, Osaka, Japan
Yao Municipal Hospital
🇯🇵Yao, Osaka, Japan
Iseikai Hospital
🇯🇵Osaka, Japan
Rinku General Medical Center
🇯🇵Izumisano, Osaka, Japan
Saiseikai Senri Hospital
🇯🇵Suita, Osaka, Japan
Kenporen Osaka Central Hospital
🇯🇵Osaka, Japan
Osaka General Medical Center
🇯🇵Osaka, Japan
Sakai City Hospital
🇯🇵Sakai, Osaka, Japan
Tane General Hospital
🇯🇵Osaka, Japan
Kawasaki Hospital
🇯🇵Kobe, Hyogo, Japan
Minoh City Hospital
🇯🇵Minoo, Osaka, Japan
Kansai Rosai Hospital
🇯🇵Amagasaki, Hyogo, Japan
Kinki Central Hospital
🇯🇵Itami, Hyogo, Japan
Nara Hospital Kinki University Faculty of Medicine
🇯🇵Ikoma, Nara, Japan
Osaka Medical Center for Cancer and Cardiovascular Diseases
🇯🇵Osaka, Japan
Nissay Hospital
🇯🇵Osaka, Japan
Osaka Rosai Hospital
🇯🇵Sakai, Osaka, Japan
Graduate School of Medicine / Faculty of Medicine, Osaka University
🇯🇵Suita, Osaka, Japan
National Hospital Organization Osaka National Hospital
🇯🇵Osaka, Japan
NTT West Osaka Hospital
🇯🇵Osaka, Japan
Osaka Koseinenkin Hospital
🇯🇵Osaka, Japan