UMIN-CTR Clinical Trial

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	21
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	Completed
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	2022 Year 10 Month 01 Day
Date of closure to data entry	2022 Year 10 Month 14 Day
Date trial data considered complete	2022 Year 10 Month 14 Day
Date analysis concluded	2022 Year 10 Month 14 Day

Other
Other related information

Management information
Registered date	2019 Year 05 Month 24 Day
Last modified on	2022 Year 11 Month 25 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000041977