UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020519 |
|---|---|
| Receipt number | R000023690 |
| Scientific Title | A phase I clinical trial of stereotactic body radiotherapy for patients with cervical cancer unsuitable for intracavitary brachytherapy |
| Date of disclosure of the study information | 2016/01/11 |
| Last modified on | 2019/05/11 16:03:53 |
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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
| Obstetrics 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
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
karasawa@cick.jp
Public contact
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/
keiito@cick.jp
Sponsor or person
Institute
Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023690
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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