Phase III trial of upfront debulking surgery vs. neoadjuvant chemotherapy for stage III/IV ovarian, tubal and peritoneal cancers (JCOG0602, OV-NACTC-P3)

UMIN ID: UMIN000000523

Registered date:17/11/2006

Basic Information

• Recruitment status: Complete: follow-up continuing
• Health condition(s) or Problem(s) studied: stage III/IV mullerian carcinomas such as ovarian, tubal and peritoneal carcinomas
• Date of first enrollment: 2006/11/01
• Target sample size: 300
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

A: Primary debulking surgery followed by chemotherapy
B: Neoaduvant chemptherapy followed by interval debulking surgery

Outcome(s)

• Primary Outcome: overall survival
• Secondary Outcome: proportion of clinical complete remission, progression free survival, response rate, adverse event, surgical invasiveness

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 75years-old
• Gender: Female
• Exclude criteria: 1) synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ 2) pregnant or nursing 3) severe mental disorders 4) systemic and continuous use of steroidal drugs 5) positive for serum hepatitis B surface antigen 6) active infections 7) uncontrolled hypertension 8) diabetes mellitus, uncontrolled or controlled with insulin 9) history of cardiac failure, unstable angina, myocardial infarction within 6 months prior to the registration 10) hypersensitivity to polyoxyethylated castor oill 11) intestinal occlusion necessary for surgical treatment 12) hypersensitivity to alcohol

Related Information

• Primary Sponsor: Japan Clinical Oncology Group(JCOG)
• Source(s) of Monetary Support: Ministry of Health, Labour and Welfare