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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000036845
Receipt No. R000041977
Scientific Title Phase I/II clinical trial of image-guided 3 dimensional beam-convergent and extremely hypofractionated radiotherapy for patients with cervical cancer unsuitable for intracavitary brachytherapy
Date of disclosure of the study information 2019/07/01
Last modified on 2020/04/02

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Basic information
Public title Phase I/II clinical trial of stereotactic body radiotherapy in patients with cervical cancer who are unsuitable for intracavitary brachytherapy
Acronym Phase I/II clinical trial of SBRT in patients
with cervical cancer who are unsuitable for
ICBT
Scientific Title Phase I/II clinical trial of image-guided 3 dimensional beam-convergent and extremely hypofractionated radiotherapy for patients with cervical cancer unsuitable for intracavitary brachytherapy
Scientific Title:Acronym Phase I/II clinical trial of image-guided 3 dimensional beam-convergent and extremely hypofractionated RT for patients with cervical cancer unsuitable for ICBT
Region
Japan

Condition
Condition Uterine cervical cancer
Classification by specialty
Obsterics and gynecology Radiology Adult
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate prospectively the safety and efficacy of extremely hypofractionated radiotherapy in patients with cervical cancer unsuitable for intracavitary brachytherapy
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Progression-free survival at 2 years
Key secondary outcomes

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
Interventions/Control_1 Whole pelvic irradiation using IMRT (45 Gy/25 fr.), followed by extremely hypofractionated radiotherapy (21 Gy/3 fr.)
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

Not applicable
Gender Female
Key inclusion criteria 1. pathological diagnosis of primary cervical cancer
2. FIGO stage; Ib1-IIIB
3. N stage 0-1, M status 0-1 (PAN metastases only)
4. Unsuitable for intracavitary brachytherapy
5. ECOG PS; 0-2
6. No previous radiotherapy in the pelvic organs
Key exclusion criteria 1. Serious medical or psychological problems
2. Other active cancer within 3 years
3. Be pregnant or just after giving birth
Target sample size 21

Research contact person
Name of lead principal investigator
1st name Katsuyuki
Middle name
Last name Karasawa
Organization Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
Division name Dept. of Radiation Oncology
Zip code 113-8677
Address 3-18-22 Honkomagome, Bunkyo-ku,Tokyo
TEL 03-3823-2101
Email karasawa@cick.jp

Public contact
Name of contact person
1st name Kei
Middle name
Last name Ito
Organization Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
Division name Dept. of Radiation Oncology
Zip code 113-8677
Address 3-18-22 Honkomagome, Bunkyo-ku,Tokyo
TEL 03-3823-2101
Homepage URL
Email keiito@cick.jp

Sponsor
Institute Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
Institute
Department

Funding Source
Organization None
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 Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
Address 3-18-22 Honkomagome, Bunkyo-ku,Tokyo
Tel 03-3823-2101
Email research@cick.jp

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
2019 Year 07 Month 01 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 Open public recruiting
Date of protocol fixation
2019 Year 06 Month 10 Day
Date of IRB
2019 Year 06 Month 20 Day
Anticipated trial start date
2019 Year 06 Month 20 Day
Last follow-up date
2025 Year 06 Month 19 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 05 Month 24 Day
Last modified on
2020 Year 04 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041977

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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