UMIN-CTR Clinical Trial

Basic information
Public title	A phase I clinical trial of stereotactic body radiotherapy for patients with cervical cancer unsuitable for intracavitary brachytherapy
Acronym	A phase I clinical trial of stereotactic body radiotherapy for patients with cervical cancer unsuitable for intracavitary brachytherapy
Scientific Title	A phase I clinical trial of stereotactic body radiotherapy for patients with cervical cancer unsuitable for intracavitary brachytherapy
Scientific Title:Acronym	A phase I clinical trial of stereotactic body radiotherapy for patients with cervical cancer unsuitable for intracavitary brachytherapy
Region	Japan

Condition
Condition	Cervical cancer
Classification by specialty	Obsterics and gynecology Radiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the safety of stereotactic body radiotherapy for cervical cancer and to decide the recommended dose.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Phase I

Assessment
Primary outcomes	Decision of the recommended dose by adverse effects in 6 months after the treatment
Key secondary outcomes	Response rate in the arm of recommend dose Local control Adverse events

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
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. SBRT for primary lesion: 19.5 - 22.5 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, Clinical stage Ib1-IIIb 4. Unsuitable for intracavitary brachytherapy 5. Age; 20- 6. ECOG PS; 0-2 7. No previous radiotherapy in the pelvic organs 8. Written informed consent 9. Adequate organ function
Key exclusion criteria	1. Serious medical or psychological problems 2. Other active cancer 3. Be pregnant or just after giving birth
Target sample size	12

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

Public contact
1st name of contact person	1st name Middle name Last name Kei Ito
Organization	Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
Division name	Radiation Oncology
Zip code
Address	3-18-22 Honkomagome, Bunkyo-ku,Tokyo
TEL	03-3823-2101
Homepage URL	http://www.cick.jp/houshasenchiryou/
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	Self funding
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	2016 Year 01 Month 11 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	Main results already published
Date of protocol fixation	2015 Year 11 Month 30 Day
Date of IRB	2015 Year 12 Month 18 Day
Anticipated trial start date	2016 Year 01 Month 01 Day
Last follow-up date	2018 Year 12 Month 31 Day
Date of closure to data entry	2019 Year 02 Month 01 Day
Date trial data considered complete	2019 Year 02 Month 01 Day
Date analysis concluded	2019 Year 02 Month 01 Day

Other
Other related information

Management information
Registered date	2016 Year 01 Month 11 Day
Last modified on	2019 Year 05 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023690