UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055987 |
|---|---|
| Receipt number | R000063312 |
| Scientific Title | Pilot Study of External Beam Radiotherapy Boost Using MR-linac for Cervical Cancer Unsuitable for Brachytherapy |
| Date of disclosure of the study information | 2024/12/01 |
| Last modified on | 2024/10/30 10:05:32 |
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Basic information
Public title
Pilot study of MR-linac boost for cervical cancer unsuitable for Brachytherapy
Acronym
Pilot Study of MR-Linac boost for Cervical Cancer Unsuitable for Brachytherapy
Scientific Title
Pilot Study of External Beam Radiotherapy Boost Using MR-linac for Cervical Cancer Unsuitable for Brachytherapy
Scientific Title:Acronym
Pilot Study of MR-Linac boost for Cervical Cancer Unsuitable for Brachytherapy
Region
| Japan |
Condition
Condition
Cervical cancer
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study aims to assess the safety of stereotactic body radiation therapy using MR-linac as an alternative to brachytherapy in patients with cervical cancer who are ineligible for brachytherapy. Six patients will be treated in the trial to demonstrate minimal safety, and the incidence of dose-limiting toxicity (DLT) will be assessed one year after enrolment.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence rate of dose-limiting toxicity (DLT) after one year of enrolment
DLT is defined as. Grading is based on CTCAE version 5.0. Non-infectious cystitis, urinary retention, bladder perforation, or urinary fistula of Grade 3 or above-Rectal hemorrhage, rectal ulcer, ileus, small bowel perforation, rectal perforation, or rectal fistula of Grade 3 or above-Hematuria of Grade 4 or above-Diarrhea, small bowel mucositis or rectal mucositis of Grade 4 or above-Radiation dermatitis of Grade 4 or above (unexpected severe adverse reactions other than those listed above are also defined) (unexpected severe adverse reactions other than those listed above may also be considered DLT if they are considered clinically serious).
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
Patients meeting all criteria are eligible:
Primary cervical cancer with squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma proven pathologically.
Advanced staging (Nissan 2020, FIGO 2018): IB1-3, IIA1-2, IIB, IIIA, IIIB, IIIC. Pelvic lymph node metastases: significant enlargement of basilar ligament, closed, external iliac, internal iliac, common iliac, or sacral iliac nodes, or significant accumulation on PET-CT. Para-aortic lymph node metastases: enlargement of lymph nodes around the aorta/inferior vena cava (>1 cm) at the level of the left renal vein and aortic bifurcation or PET-CT accumulation.
Brachytherapy not feasible due to: (1) Primary lesion >7 cm on MRI T2-weighted image. (2) Comorbidities: uterine fibroids or dementia. (3) Anatomical issues: narrow vagina, etc. (4) Difficulty in administering adequate sedation/analgesia. (5) Institutional difficulty in sedation/analgesia even after consultation. (6) Patient refusal of brachytherapy. (7) Other cases where brachytherapy is judged ineligible (e.g., very old age). *Two-step registration required if reason (1) is met.
Age >=18 years.
ECOG PS: 0-2.
No history of pelvic radiotherapy.
Informed consent obtained.
Blood tests within 14 days before enrollment meet:
WBC >=3000/mm3, Hb >=10 g/dL (correction acceptable), platelets >=100000/mm3,
Serum total bilirubin <1.5x upper limit,
Serum AST/ALT <3x upper limit,
Serum creatinine <3.0 mg/dL,
Creatinine clearance >10 mL/min
Key exclusion criteria
1) Patients with serious complications. Difficult-to-control cardiac disease, hypertension, diabetes, psychosis, refractory infections, acute peptic ulcers, etc.
2) Patients with active multiple cancers diagnosed within 3 years. However, lesions equivalent to intraepithelial or intramucosal carcinoma that are considered curable by local treatment are not included in active overlapping cancer.
3) Patients who are pregnant, possibly pregnant, within 28 days postpartum, or lactating.
4) Other patients who are deemed by the investigator to be unsuitable for the safe conduct of this study.
Target sample size
6
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Uno |
Organization
Chiba University Hospital
Division name
Department of Radiology
Zip code
260-8670
Address
1-8-1, Inohana, Chuo-ku, Chiba-city Chiba
TEL
0432262100
unotakas@faculty.chiba-u.jp
Public contact
Name of contact person
| 1st name | Miho |
| Middle name | |
| Last name | Watanabe |
Organization
Chiba University Hospital
Division name
Department of Radiology
Zip code
260-8670
Address
1-8-1, Inohana, Chuo-ku, Chiba-shi, Chiba
TEL
0432227171
Homepage URL
mwatanabe@hospital.chiba-u.jp
Sponsor or person
Institute
Chiba University Hospital
Institute
Department
Personal name
MIHO NEMOTO
Funding Source
Organization
Japan Society for the Promotion of Science
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
Chiba University Hospital
Address
1-8-1, Inohana, Chuo-ku, Chiba-shi, Chiba
Tel
0432227171
inohana-rinri@chiba-u.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
| 2024 | Year | 12 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 11 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Cases to be enrolled in a prospective observational study of MR image-guided immediate adaptive radiation therapy using an MRI image-guided radiotherapy system (M10434) will be included in the analysis.
Management information
Registered date
| 2024 | Year | 10 | Month | 30 | Day |
Last modified on
| 2024 | Year | 10 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063312
