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Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000009726
Receipt No. R000011321
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)
Date of disclosure of the study information 2013/01/08
Last modified on 2017/08/23

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Basic information
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
Condition Tumor diameter 2cm or less FIGO stage Ib1 uterine cervical cancer
Classification by specialty
Obsterics and gynecology Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
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

Assessment
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

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
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

Eligibility
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

Research contact person
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

Public contact
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

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)

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(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)

Other administrative information
Date of disclosure of the study information
2013 Year 01 Month 08 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 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
Other related information

Management information
Registered date
2013 Year 01 Month 08 Day
Last modified on
2017 Year 08 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011321

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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