UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000005417
Receipt number R000006427
Scientific Title Treatment outcome and reproductive function of patients with yolk sac tumor (YST) of the ovary in Japan; A retrospective study
Date of disclosure of the study information 2011/04/11
Last modified on 2016/10/18 13:12:45

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Basic information

Public title

Treatment outcome and reproductive function of patients with yolk sac tumor (YST) of the ovary in Japan; A retrospective study

Acronym

A study for YST

Scientific Title

Treatment outcome and reproductive function of patients with yolk sac tumor (YST) of the ovary in Japan; A retrospective study

Scientific Title:Acronym

A study for YST

Region

Japan


Condition

Condition

Yolk sac tumor (YST) of the ovary

Classification by specialty

Obstetrics and Gynecology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To clarify improvement of outcome in patients with YST by transitions of the standard treatment.

Basic objectives2

Others

Basic objectives -Others

Retrospective study

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Recurrence-free survival

Key secondary outcomes

Overall survival
Rate of patients with recuperation of menstruation cycle after treatment
Rate of patients who became pregnancy after treatment
Rate of patients who got child after treatment


Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


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


Not applicable

Age-upper limit


Not applicable

Gender

Female

Key inclusion criteria

Patients with YST (including the mixed type) who received any treatment from January 1st, 1980 to December 31st, 2007.

Key exclusion criteria

Not applicable

Target sample size

300


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hiroyuki Yoshikawa

Organization

Graduate School of Comprehensive Human Sciences, University of Tsukuba

Division name

Department of Obstetrics and Gynecology

Zip code


Address

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

TEL

029-853-3049

Email

hyoshi@md.tsukuba.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Toyomi Satoh

Organization

Graduate School of Comprehensive Human Sciences, University of Tsukuba

Division name

Department of Obstetrics and Gynecology

Zip code


Address

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

TEL

029-853-3073

Homepage URL


Email

toyomi-s@md.tsukuba.ac.jp


Sponsor or person

Institute

Gynecologic Cancer Study Group of Japan Clinical Oncology Group

Institute

Department

Personal name



Funding Source

Organization

Ministry of Health, Labour and Welfare

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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


Other administrative information

Date of disclosure of the study information

2011 Year 04 Month 11 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications

http://www.sciencedirect.com/science/article/pii/S0959804914011642

Number of participants that the trial has enrolled


Results

RESULTS:
There were 211 patients enrolled from 43 institutions. The BEP regimen and a non-BEP regimen were administered to 112 and 99 patients as postoperative chemotherapy, respectively. BEP was significantly superior to non-BEP in 5-year OS (93.6% versus 74.6%, P=0.0004). Reduced-dose BEP was significantly associated with poorer 5-year OS compared with standard-dose BEP (89.4% versus 100%, P=0.02 and 62.5% versus 96.9%, P=0.0002). All patients who underwent fertility-sparing surgery recovered their menstrual cycles. Sixteen of 23 patients receiving BEP (70.0%) and 13 of 17 patients receiving non-BEP (76.5%) who were nulliparous at fertility-sparing surgery and married at the time of investigation gave birth to 21 and 19 healthy children, respectively.
CONCLUSIONS:
The results of the present study suggest that standard-dose BEP should be administered for ovarian YST. BEP is as safe as non-BEP for preserving reproductive function.

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



Progress

Recruitment status

Completed

Date of protocol fixation

2011 Year 04 Month 05 Day

Date of IRB


Anticipated trial start date

2011 Year 04 Month 01 Day

Last follow-up date


Date of closure to data entry

2012 Year 12 Month 01 Day

Date trial data considered complete

2013 Year 03 Month 01 Day

Date analysis concluded

2013 Year 11 Month 30 Day


Other

Other related information

Satoh T, et al. Administration of standard-dose BEP regimen (bleomycin+etoposide+cisplatin) is essential for treatment of ovarian yolk sac tumor. Eur J Cancer 2015;51:340-51.


Management information

Registered date

2011 Year 04 Month 09 Day

Last modified on

2016 Year 10 Month 18 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006427


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name