UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A non-randomized confirmatory study to expand the indication of fertility-sparing surgery for patients with epithelial ovarian cancer (JCOG1203, FSS for EOC)
Title of the study (Brief title)	A non-randomized confirmatory study to expand the indication of fertility-sparing surgery for patients with epithelial ovarian cancer (JCOG1203, FSS for EOC)
Region	Japan

Condition
Condition	Presumed ovarian clear cell carcinoma stage IA or other type of epithelial ovarian carcinoma stage IC (unilateral) grade 1/2 before complete fertility-sparing surgery
Classification by specialty	Obsterics and gynecology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To demonstrate the efficacy of fertility-sparing surgery for patients with ovarian clear cell carcinoma stage IA or other type of epithelial ovarian carcinoma stage IC (unilateral) grade 1/2
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Phase III

Assessment
Primary outcomes	5-year overall survival
Key secondary outcomes	Overall survival, recurrence-free survival, lethal recurrence-free survival, recovered menstruation proportion, recovered menstruation cycle proportion, pregnancy proportion, live birth proportion, intra and postoperative complication, adverse events, severe adverse events

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	A: Fertility-sparing surgery with staging surgery. Adjuvant chemotherapy is performed on patients who were diagnosed as having ovarian clear cell carcinoma stage IA or other type of epithelial ovarian carcinoma stage IC (unilateral) grade 1/2 after surgery.
Interventions/Control_2
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	16 years-old <=
Age-upper limit	42 years-old >=
Gender	Female
Key inclusion criteria	(1) To fulfill I or II I. When tumor is detected in pelvic enhanced MRI and CT within 84 days before registration and it is presumed stage I epithelial ovarian cancer (neither surgery nor biopsy for ovarian tumor before registration), both of the followings are fulfilled: 1) Existence of ovarian tumor with solid part which is suspected as epithelial ovarian cancer 2) No Lymph node or distant metastasis by imaging examination II. When incomplete staging surgery is performed on a patient with ovarian tumor by laparotomy or laparoscopic surgery within 84 days before registration and the tumor is diagnosed as epithelial ovarian cancer histologically, the following (1) to (4) are fulfilled: 1) Diagnosed as either i), ii) or iii) by some specimens of resected ovarian tumor or biopsy at surgery within 84 days before registration i) Clear cell histology (CCH) ii) Non-clear cell histology epithelial cancer [serous, mucinous, endometrioid] (non-CCH) Grade 1 iii) Non-clear cell histology epithelial cancer [serous, endometrioid] (non-CCH) Grade 2 2) Possibility of one of the following stage (FIGO 2014) after fertility-sparing surgery (FSS) i) Clear cell histology: stage IA ii) Non-clear cell histology: stage IC (unilateral) 3) Needing to receive re-staging surgery 4) The uterus and the ovary being left (2) The patient wishes to receive FSS by informed consent. (3) Keeping an ability of childbirth (4) ECOG performance status (PS) of 0 or 1 (5) Measurable disease or non-measurable (6) No prior treatment with irradiation or chemotherapy for any malignancy. (7) Adequate organ functions (8) No abnormal finding to need treatment on 12-lead ECG (9) Written informed consent by the patient of 20 years or older. Written informed consent by both of the patient and the parent, if the patient is under 20 years old
Key exclusion criteria	(1)Synchronous or metachronous (within 5 years) malignancies except for carcinoma in situ or intramucosal tumors curatively treated with local therapy (2) Active systemic infections to be treated. (3) Body temperature of 38 or more degrees Celsius (4) Women during pregnancy, possible pregnancy, or breast-feeding (5) Psychiatric disease (6) Continuous systemic steroid treatment (7) Uncontrolled diabetes mellitus or routine administration of insulin (8) Uncontrolled hypertension (9) Unstable angina or prior myocardial infarction with in 6 months (10) HBs antigen positive, HCV antibody positive, HIV antibody positive (11) Interstitial pneumonia, pulmonary fibrosis, severe pulmonary emphysema (12) hypersensitivity to polyoxyethylated castor oil (13) hypersensitivity to alcohol
Target sample size	600

Research contact person
Name of lead principal investigator	Toyomi Satoh
Organization	Faculty of Medicine, University of Tsukuba
Division name	Obstetrics & Gynecology
Address	1-1-1, Tennoudai, Tsukuba-city, Ibaraki, Japan
TEL	029-853-3049
Email	toyomi-s@md.tsukuba.ac.jp

Public contact
Name of contact person	Toyomi Satoh
Organization	JCOG1203 Coordinating Office
Division name	Obstetrics & Gynecology, Faculty of Medicine, University of Tsukuba
Address	1-1-1, Tennoudai, Tsukuba-city, Ibaraki, Japan
TEL	029-853-3049
Homepage URL	http://www.jcog.jp/
Email	JCOG_sir@ml.jcog.jp

Sponsor
Institute	Japan Clinical Oncology Group (JCOG)
Institute
Department

Funding Source
Organization	Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization	Other
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） 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） 茨城県立中央病院・茨城県地域がんセンター（茨城県） 群馬県立がんセンター（群馬県） 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） 千葉大学医学部（千葉県） 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） 東京女子医科大学（東京都） 慶應義塾大学病院（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） 神奈川県立病院機構神奈川県立がんセンター（神奈川県） 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） 新潟大学医歯学総合病院（新潟県） 信州大学医学部（長野県） 静岡県立静岡がんセンター（静岡県） 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） 大阪国際がんセンター（大阪府） 大阪市立総合医療センター（大阪府） 大阪医科大学（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） 愛媛大学医学部附属病院（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） 鹿児島大学病院（鹿児島県） 鹿児島市立病院（鹿児島県） 琉球大学医学部附属病院（沖縄県）

Other administrative information
Date of disclosure of the study information	2014 Year 03 Month 10 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2014 Year 01 Month 14 Day
Anticipated trial start date	2014 Year 03 Month 10 Day
Last follow-up date	2032 Year 09 Month 10 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	2014 Year 03 Month 10 Day
Last modified on	2018 Year 01 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015382