UMIN-CTR Clinical Trial

Public title

A non-randomized confirmatory study to expand the indication of fertility-sparing surgery for patients with epithelial ovarian cancer (JCOG1203, FSS for EOC)

Acronym

A non-randomized confirmatory study to expand the indication of fertility-sparing surgery for patients with epithelial ovarian cancer (JCOG1203, FSS for EOC)

Scientific Title

A non-randomized confirmatory study to expand the indication of fertility-sparing surgery for patients with epithelial ovarian cancer (JCOG1203, FSS for EOC)

Scientific Title:Acronym

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

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

Obstetrics and Gynecology

Classification by malignancy

Malignancy

Genomic information

NO

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

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

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Historical

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

Name of lead principal investigator

1st name
Middle name
Last name	Toyomi Satoh

Organization

Faculty of Medicine, University of Tsukuba

Division name

Obstetrics & Gynecology

Zip code

Address

1-1-1, Tennoudai, Tsukuba-city, Ibaraki, Japan

TEL

029-853-3049

Email

toyomi-s@md.tsukuba.ac.jp

Name of contact person

1st name
Middle name
Last name	Toyomi Satoh

Organization

JCOG1203 Coordinating Office

Division name

Obstetrics & Gynecology, Faculty of Medicine, University of Tsukuba

Zip code

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

Institute

Japan Clinical Oncology Group (JCOG)

Institute

Department

Personal name

Organization

Japan Agency for Medical Research and Development

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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）

Date of disclosure of the study information

2014

Year

03

Month

10

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Open public recruiting

Date of protocol fixation

2014

Year

01

Month

14

Day

Date of IRB

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

Other related information

Registered date

2014

Year

03

Month

10

Day

Last modified on

2018

Year

01

Month

30

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015382