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UMIN ID: C000000005

Registered date:07/06/2005

Feasibility study of neoadjuvant chemotherapy followed by interval cytoreductive surgery for stage III/IV ovarian, tubal and peritoneal cancers.(JCOG0206, OVCA-NAC-P2)

Basic Information

Recruitment status	Complete: follow-up complete
Health condition(s) or Problem(s) studied	stage III/IV ovarian, tubal and peritoneal carcinomas
Date of first enrollment	2003/03/01
Target sample size	56
Countries of recruitment	Japan
Study type	Interventional
Intervention(s)	Diagnostic laparoscopy, Interval Cytoreductive Surgery(ICS), Neoadjuvant and Post-surgical chemotherapy (Paclitaxel and Carboplatin)

TO Original Data: UMIN

Outcome(s)

Primary Outcome	proportion of clinical complete remission
Secondary Outcome	1) positive predictive value (PPV) of prelaparoscopic diagnosis concerning the origin and histology; proportion of the patients diagnosed as müllerian carcinoma by laparoscopic inspection and histopathology of biopsy specimen among those diagnosed by prelaparoscopic findings 2) PPV of prelaparoscopic diagnosis concerning clinical stage; proportion of the patients diagnosed as stage III or IV by laparoscopic inspection among those diagnosed by prelaparoscopic findings 3) PPV of overall prelaparoscopic diagnosis; proportion of the patients diagnosed as stage III or IV müllerian carcinoma by laparoscopic inspection and histopathology of biopsy specimen among those diagnosed by prelaparoscopic findings 4) response rate to NAC among patients whose clinical diagnosis is confirmed by laparoscopy 5) proportion of patients who received ICS among patients whose clinical diagnosis is confirmed by laparoscopy 6) progression-free survival among patients whose clinical diagnosis is confirmed by laparoscopy 7) operative morbidity among all enrolled patients 8) adverse events among all enrolled patients 9) overall survival among all enrolled patients

Primary Outcome

proportion of clinical complete remission

Secondary Outcome

1) positive predictive value (PPV) of prelaparoscopic diagnosis concerning the origin and histology; proportion of the patients diagnosed as müllerian carcinoma by laparoscopic inspection and histopathology of biopsy specimen among those diagnosed by prelaparoscopic findings 2) PPV of prelaparoscopic diagnosis concerning clinical stage; proportion of the patients diagnosed as stage III or IV by laparoscopic inspection among those diagnosed by prelaparoscopic findings 3) PPV of overall prelaparoscopic diagnosis; proportion of the patients diagnosed as stage III or IV müllerian carcinoma by laparoscopic inspection and histopathology of biopsy specimen among those diagnosed by prelaparoscopic findings 4) response rate to NAC among patients whose clinical diagnosis is confirmed by laparoscopy 5) proportion of patients who received ICS among patients whose clinical diagnosis is confirmed by laparoscopy 6) progression-free survival among patients whose clinical diagnosis is confirmed by laparoscopy 7) operative morbidity among all enrolled patients 8) adverse events among all enrolled patients 9) overall survival among all enrolled patients

Key inclusion & exclusion criteria

Age minimum	20years-old
Age maximum	75years-old
Gender	Female
Include criteria
Exclude criteria	-synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ -pregnant or nursing -severe mental disorders -systemic and continuous use of steroidal drugs -active infections -uncontrolled hypertension -diabetes mellitus, uncontrolled or controlled with insulin -history of cardiac failure, unstable angina, myocardial infarction within 6 months prior to the registration -liver cirrhosis or bleeding tendency contraindicating debulking surgery -intestinal occlusion necessary for surgical treatment -hypersensitivity to alcohol

Related Information

Primary Sponsor	Japan Clinical Oncology Group(JCOG)
Secondary Sponsor
Source(s) of Monetary Support	Ministry of Health, Labour and Welfare
Secondary ID(s)	NCT00112086

Contact

public contact
Name	Takashi Onda, MD
Address	5-1-1 Tsukiji,Chuo-ku,Tokyo,104-0045,JAPAN Japan
Telephone
E-mail	JCOG_sir@ml.jcog.jp
Affiliation	JCOG0206 Coordinating office Division of Gynecologic Oncology, National Cancer Center Hospital
scientific contact
Name	Hiroyuki Yoshikawa, MD
Address	1-1-1 Tennoudai, Tsukuba, Ibaraki 305-8575, Japan Japan
Telephone
E-mail
Affiliation	University of Tsukuba Department of Obstetrics and Gynecology, Institute of Clinical Medicine

TO Original Data: UMIN