UMIN-CTR Clinical Trial

Public title

Nonrandomized confirmatory trial of modified radical hysterectomy for patients with tumor diameter 2cm or less FIGO stage Ib1 uterine cervical cancer (JCOG1101, CC-MoRH)

Acronym

Nonrandomized confirmatory trial of modified radical hysterectomy for patients with tumor diameter 2cm or less FIGO stage Ib1 uterine cervical cancer (JCOG1101, CC-MoRH)

Scientific Title

Nonrandomized confirmatory trial of modified radical hysterectomy for patients with tumor diameter 2cm or less FIGO stage Ib1 uterine cervical cancer (JCOG1101, CC-MoRH)

Scientific Title:Acronym

Nonrandomized confirmatory trial of modified radical hysterectomy for patients with tumor diameter 2cm or less FIGO stage Ib1 uterine cervical cancer (JCOG1101, CC-MoRH)

Region

Japan

Condition

Tumor diameter 2cm or less FIGO stage Ib1 uterine cervical cancer

Classification by specialty

Obstetrics and Gynecology

Radiology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To demonstrate the non-inferioirity of modified radical hysterectomy as compared to historical data of radical hysterectomy in 5-year overall survival for patients with tumor diameter 2cm or less FIGO stage Ib1 uterine cervical cancer

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, relapse-free survival, local relapse-free survival, completion rate of modified radical hysterectomy, local relapse rate, pathological parametrial involvement rate, days until self urination and residual urine disappearance, bleeding volume, operation time, rate of postoperative radiation therapy or concurrent chemoradiotherapy, 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

Device,equipment

Maneuver

Interventions/Control_1

A: Modified radical hysterectomy with systematic pelvic lymphadenectomy. Ovarian preservation is possible in non-metastatic premenopausal cases with squamous-cell carcinoma. Postoperative radiotherapy is applied for moderate risk cases. Postoperative concurrent chemoradiotherapy is applied for high risk cases.

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

20

years-old

<=

Age-upper limit

70

years-old

>=

Gender

Female

Key inclusion criteria

1) Any one of the following histology in primary lesion located at uterine cervix.
i) Squamous cell carcinoma (keratinizing or nonkeratinizing type)
ii) Adenosquamous carcinoma (except for glassy cell carcinoma)
iii) Adenocarcinoma (endocervical type mucinous adenocarcinoma, intestinal type mucinous adenocarcinoma, or endometrioid adenocarcinoma)
2) To fulfill i) or ii) in clinical stage IB1 (The General Rules for Clinical and Pathological Management of Uterine Cervical Cancer, the 3rd edition, 2012)
i) When tumor is detected in pelvic MRI within 56 days before registration and its maximum diameter is 2cm or less, (a) or (b) are fulfilled
(a) In case with diagnostic conization of the cervix within 49 days before registration, the maximum length of invasive tumor is 2 cm or less with the diagnostic conization
(b) In case without diagnostic conization of the cervix, invasive tumor is not detected or length of invasive tumor is 2 cm or less in colposcopy within 56 days before registration
ii) When tumor is not detected in pelvic MRI within 56 days before registration, (a) or (b) are fulfilled
(a) When invasive tumor is not detected in colposcopy within 56 days before registration, the maximum length of invasive tumor is 2 cm or less with diagnostic conization of the cervix within 49 days before registration
(b) Invasive tumor is detected and the maximum length of the tumor is 2 cm or less in colposcopy within 56 days before registration
3) Neither distant lymph node metastasis nor distant metastasis in abdominal and pelvic computed tomography within 56 days before registration
4) Aged 20 to 70 years old
5) ECOG performance status (PS) of 0 or 1
6) No following prior treatment
i) Surgery except for cervical conization for uterine cervical cancer
ii) Surgery for lower abdominal or pelvic malignancy
iii) Radiation therapy or chemotherapy for other malignancies
7) Adequate organ functions
8) Written informed consent

Key exclusion criteria

1) Simultaneous or metachronous (within 5 years) double cancers except carcinoma in situ or intramucosal tumor.
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

Target sample size

240

Name of lead principal investigator

1st name
Middle name
Last name	Takahiro Kasamatsu

Organization

Tokyo Metropolitan Bokutoh Hospital

Division name

Obstetrics & Gynecology

Zip code

Address

4-23-15 Kotobashi, Sumida-ku, Tokyo 130-8575

TEL

03-3633-6151

Email

takahiro_kasamatsu@tmhp.jp

Name of contact person

1st name
Middle name
Last name	Takahide Arimoto

Organization

JCOG1101 Coordinating Office

Division name

Obstetrics and Gynecology, Gynecologic Surgery, The University of Tokyo Hospital

Zip code

Address

7-3-1,Hongo,Bunkyo-ku,Tokyo,Japan

TEL

(03)-3815-5411

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）
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）
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）
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）
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）
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）
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）
鹿児島大学医学部・歯学部附属病院（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

2013

Year

01

Month

08

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

No longer recruiting

Date of protocol fixation

2012

Year

11

Month

29

Day

Date of IRB

Anticipated trial start date

2013

Year

01

Month

08

Day

Last follow-up date

2023

Year

01

Month

08

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2013

Year

01

Month

08

Day

Last modified on

2017

Year

08

Month

23

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011321