NIPH Clinical Trials Search

UMIN ID: UMIN000000523

Registered date:17/11/2006

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

Basic Information

Recruitment status Complete: follow-up continuing
Health condition(s) or Problem(s) studiedstage III/IV mullerian carcinomas such as ovarian, tubal and peritoneal carcinomas
Date of first enrollment2006/11/01
Target sample size300
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)A: Primary debulking surgery followed by chemotherapy B: Neoaduvant chemptherapy followed by interval debulking surgery


Primary Outcomeoverall survival
Secondary Outcomeproportion of clinical complete remission, progression free survival, response rate, adverse event, surgical invasiveness

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximum75years-old
Include criteria
Exclude criteria1) 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


public contact
Name Takashi Onda
Address 1-15-1, Kitasato,Sagamihara-shi,Kanagawa 252-0375, JAPAN Japan
Telephone 042-778-8111
Affiliation JCOG0602 Coordinating Office Department of Obstetrics and Gynecology School of Medicine, Kitasato University Hospital
scientific contact
Name Hiroyuki Yoshikawa
Address 6528 Koibuchi, Kasama, Ibaraki 309-1793, JAPAN Japan
Telephone 0296-77-1121
Affiliation Ibaraki Prefectural Central Hospita Department of Obstetrics and Gynecology