UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062139 |
|---|---|
| Receipt number | R000070352 |
| Scientific Title | Clinical trial of ultra-hypofractionated small pelvic irradiation for cervical cancer using online adaptive radiotherapy with MR linac |
| Date of disclosure of the study information | 2026/07/04 |
| Last modified on | 2026/07/04 17:22:36 |
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Basic information
Public title
Clinical trial of ultra-hypofractionated small pelvic irradiation for cervical cancer using online adaptive radiotherapy with MR linac
Acronym
Clinical trial of ultra-hypofractionated radiotherapy for cervical cancer using MR linac
Scientific Title
Clinical trial of ultra-hypofractionated small pelvic irradiation for cervical cancer using online adaptive radiotherapy with MR linac
Scientific Title:Acronym
Clinical trial of ultra-hypofractionated radiotherapy for cervical cancer using MR linac
Region
| Japan |
Condition
Condition
Cervical cancer
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the safety and efficacy of ultra-hypofractionated small pelvic irradiation for cervical cancer using online adaptive radiotherapy with MR linac.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The 2-year pelvic control
Key secondary outcomes
The 2-year local control, the 2-year progress-free survival, acute toxicity, late toxicity
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
Small pelvic irradiation with 30 Gy in 5 fractions using MR linac (twice a week).
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) Cervical cancer stage IB1-2, stage IIA1 (FIGO2018) without corpus invasion, for which curative radiation therapy is planned, or cases with a moderate risk of postoperative recurrence (for cases without lymph node dissection, the preoperative tumor diameter must be less than 4 cm).
(2) Histologically proven squamous cell carcinoma.
(3) 20 years or older (at registration).
(4) ECOG PS of 0-2
(5) No prior history of radiation therapy to the abdomen or pelvis.
(6) Adequate organ functions
(7) Written informed consent
Key exclusion criteria
(1) Patients with severe complications (heart failure, renal failure, hepatic failure, respiratory dysfunction, lymphatic obstruction, poorly controlled diabetes, etc.).
(2) Patients with metal implants that are not compatible with MRI.
(3) Patients who have difficulty maintaining a supine position due to claustrophobia, etc.
(4) An infectious disease (excluding viral hepatitis) that requires systemic treatment
(5) Other active malignancy at the start of our study
(6) Patients requiring systemic steroids medication or other immunosuppressants
(7) Women who are pregnant, possibly pregnant, within 28 days postpartum, or breastfeeding.
(8) Patients with severe psychological disorder
(9) Other cases that were judged to be inappropriate for conducting this study
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Rei |
| Middle name | umezawa |
| Last name | Umezawa |
Organization
Tohoku University Hospital
Division name
Department of Radiation Oncology
Zip code
980-8574
Address
1-1 Seiryo-machi, Aoba-ku, Sendai
TEL
022-717-7312
reirei513@hotmail.com
Public contact
Name of contact person
| 1st name | Rei |
| Middle name | umezawa |
| Last name | Umezawa |
Organization
Tohoku University Hospital
Division name
Department of Radiation Oncology
Zip code
980-8574
Address
1-1 Seiryo-machi, Aoba-ku, Sendai
TEL
022-717-7312
Homepage URL
reirei513@hotmail.com
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Grant-in-Aid for Scientific Research (C)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee Tohoku University Hospital
Address
1-1 Seiryo-machi, Aoba-ku, Sendai
Tel
022-728-4105
ec@rinri.hosp.tohoku.ac.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
| 2026 | Year | 07 | Month | 04 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 05 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2031 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 07 | Month | 04 | Day |
Last modified on
| 2026 | Year | 07 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070352
