UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase III trial of upfront debulking surgery vs. neoadjuvant chemotherapy for stage III/IV ovarian, tubal and peritoneal cancers (JCOG0602, OV-NACTC-P3)
Title of the study (Brief title)	Phase III trial of upfront debulking surgery vs. neoadjuvant chemotherapy for stage III/IV ovarian, tubal and peritoneal cancers (JCOG0602, OV-NACTC-P3)
Region	Japan

Condition
Condition	stage III/IV mullerian carcinomas such as ovarian, tubal and peritoneal carcinomas
Classification by specialty	Obsterics and gynecology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To compare the usefulness of neoadjuvant chemotherapy with current standard treatment procedure, debulking surgery in advance of chemotherapy, in patients with stage III/IV ovarian, tubal and peritoneal cancers.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Phase III

Assessment
Primary outcomes	overall survival
Key secondary outcomes	proportion of clinical complete remission, progression free survival, response rate, adverse event, surgical invasiveness

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	NO
Dynamic allocation	YES
Institution consideration	Institution is considered as adjustment factor in dynamic allocation.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine Maneuver
Interventions/Control_1	A: Primary debulking surgery followed by chemotherapy
Interventions/Control_2	B: Neoaduvant chemptherapy followed by interval debulking surgery
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	75 years-old >=
Gender	Female
Key inclusion criteria	1) stage III or IV mullerian carcinoma by clinical findings including imaging studies (CT or MRI) and cytology of ascites, pleural effusions, or fluids obtained by tumor centesis 2) clinically deemed to be a candidate for debulking surgery without evidence of brain, bone, bone marrow metastasis 3) CA125>200U/mL and CEA<20ng/mL 4) Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 3 5) presence of any measurable lesions is not required 6) previously untreated for these malignancies and no history of treatment with chemotherapy nor radiotherapy even for other diseases 7) adequate bone marrow, hepatic, renal, cardiac and respiratory functions 8) written informed consent
Key exclusion 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
Target sample size	300

Research contact person
Name of lead principal investigator	Hiroyuki Yoshikawa
Organization	Ibaraki Prefectural Central Hospita
Division name	Department of Obstetrics and Gynecology
Address	6528 Koibuchi, Kasama, Ibaraki 309-1793, JAPAN
TEL	0296-77-1121
Email	h-yoshikawa@chubyoin.pref.ibaraki.jp

Public contact
Name of contact person	Takashi Onda
Organization	JCOG0602 Coordinating Office
Division name	Department of Obstetrics and Gynecology School of Medicine, Kitasato University Hospital
Address	1-15-1, Kitasato,Sagamihara-shi,Kanagawa 252-0375, JAPAN
TEL	042-778-8111
Homepage URL	http://www.jcog.jp/
Email	JCOG_sir@ml.jcog.jp

Sponsor
Institute	Japan Clinical Oncology Group(JCOG)
Institute
Department

Funding Source
Organization	Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions

Institutions

北海道大学病院（北海道） 札幌医科大学（北海道） 岩手医科大学（岩手県） 東北大学病院（宮城県） 筑波大学医学医療系（茨城県） 防衛医科大学校（埼玉県） 埼玉県立がんセンター（埼玉県） 埼玉医科大学総合医療センター（埼玉県） 東京慈恵会医科大学附属柏病院（千葉県） 国立がん研究センター中央病院（東京都） がん・感染症センター都立駒込病院（東京都） 東京慈恵会医科大学附属病院（東京都） がん研究会有明病院（東京都） 東京大学医学部（東京都） 順天堂大学医学部附属順天堂医院（東京都） NTT東日本関東病院（東京都） 北里大学医学部（神奈川県） 新潟県立がんセンター新潟病院（新潟県） 信州大学医学部（長野県） 愛知県がんセンター中央病院（愛知県） 名古屋大学医学部（愛知県） 京都大学医学部附属病院（京都府） 大阪市立大学医学部附属病院（大阪府） 近畿大学医学部（大阪府） 大阪府立病院機構大阪府立成人病センター（大阪府） 大阪市立総合医療センター（大阪府） 近畿大学医学部堺病院（大阪府） 兵庫県立がんセンター（兵庫県） 鳥取大学医学部（鳥取県） 国立病院機構呉医療センター・中国がんセンター（広島県） 国立病院機構四国がんセンター（愛媛県） 国立病院機構九州がんセンター（福岡県） 久留米大学医学部（福岡県） 九州大学病院（福岡県） 佐賀大学医学部（佐賀県） 熊本大学医学部（熊本県） 鹿児島市立病院（鹿児島県） 琉球大学医学部（沖縄県）

Other administrative information
Date of disclosure of the study information	2006 Year 11 Month 17 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2006 Year 10 Month 18 Day
Anticipated trial start date	2006 Year 11 Month 01 Day
Last follow-up date	2017 Year 11 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2006 Year 11 Month 17 Day
Last modified on	2016 Year 09 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000633