UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000016285
Receipt number R000018894
Scientific Title Multi-center retrospective study of radical hysterectomy versus radiotherapy as a primary treatment for stage IB2-IIB non-squamous cell carcinoma of the uterine cervix. (SGSG-015)
Date of disclosure of the study information 2015/01/20
Last modified on 2015/01/20 23:47:31

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Basic information

Public title

Multi-center retrospective study of radical hysterectomy versus radiotherapy as a primary treatment for stage IB2-IIB non-squamous cell carcinoma of the uterine cervix. (SGSG-015)

Acronym

Surgery versus radiotherapy as a primary treatment for stage IB2-IIB non-SCC of uterine cervix. (SGSG-015)

Scientific Title

Multi-center retrospective study of radical hysterectomy versus radiotherapy as a primary treatment for stage IB2-IIB non-squamous cell carcinoma of the uterine cervix. (SGSG-015)

Scientific Title:Acronym

Surgery versus radiotherapy as a primary treatment for stage IB2-IIB non-SCC of uterine cervix. (SGSG-015)

Region

Japan


Condition

Condition

Non-squamous cell carcinoma of
uterine cervix

Classification by specialty

Obstetrics and Gynecology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the impact of radical hysterectomy on outcome of patients with stage IB2-IIB non-squamous cell carcinouma of the uterine cervix, compared with radiation therapy.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Loco-regional control rate according to the primary treatment (radical hysterectomy versus radiation therapy)

Key secondary outcomes



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

Stage IB2-IIB patients with non-squamous cell carcinoma of uteriine cervix received primary curative treatment between 2004 and 2009.

Key exclusion criteria

Small cell carcinoma and undifferentiated carcinoma

Target sample size

400


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Takayoshi Nogawa

Organization

National Hospital Organization Shikoku Cancer Center

Division name

Gynecology

Zip code


Address

160 Kou, Minamiumemoto-chou, Matsuyama

TEL

089-999-1111

Email

tnogawa@shikoku-cc.go.jp


Public contact

Name of contact person

1st name
Middle name
Last name Atsumi Kojima

Organization

Iwate Medical University

Division name

Obstetrics and Gynecology

Zip code


Address

19-1, Uchimaru, Morioka

TEL

019-651-5111

Homepage URL


Email

akojima@iwate-med.ac.jp


Sponsor or person

Institute

Sankai Gynecology Study Group

Institute

Department

Personal name



Funding Source

Organization

Sankai Gynecology Study Group

Organization

Division

Category of Funding Organization

Other

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



Other administrative information

Date of disclosure of the study information

2015 Year 01 Month 20 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

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



Progress

Recruitment status

Enrolling by invitation

Date of protocol fixation

2013 Year 09 Month 04 Day

Date of IRB


Anticipated trial start date

2013 Year 11 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

This is a multi-center retrospective study.


Management information

Registered date

2015 Year 01 Month 20 Day

Last modified on

2015 Year 01 Month 20 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018894


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name