UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054660 |
|---|---|
| Receipt number | R000062463 |
| Scientific Title | A phase II study of hypofractionated radiotherapy for esophageal cancer |
| Date of disclosure of the study information | 2024/07/12 |
| Last modified on | 2024/12/13 09:34:08 |
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Basic information
Public title
A phase II study of hypofractionated radiotherapy for esophageal cancer
Acronym
A phase II study of hypofractionated radiotherapy for esophageal cancer
Scientific Title
A phase II study of hypofractionated radiotherapy for esophageal cancer
Scientific Title:Acronym
A phase II study of hypofractionated radiotherapy for esophageal cancer
Region
| Japan |
Condition
Condition
esophageal cancer
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of hypofractionated radiotherapy for patients with esophageal cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase II
Assessment
Primary outcomes
Incidence of dysphagia 6 months after starting treatment
Key secondary outcomes
Frequency and severity of adverse events, patient QOL and response rate
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
radiotherapy
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. histologically proven esophageal cancer
2. Cases with T1-4a, N0-3, M0/1 lym (Japanese Esophageal Cancer Guidelines, 12th Edition)
3. Age 20 years or older and younger than 90 years old (at time of registration)
4. Performance Status (ECOG):0-1
5. Cases where surgery is inoperable or refusal is made
6. Cases where concurrent chemotherapy is difficult or refusal is made
7. Written consent has been obtained from the individual to participate in this clinical trial
Key exclusion criteria
1. Patients with distant organ metastases other than supraclavicular or longitudinal lymph nodes.
2. Patients with a history of radiation therapy near the lesion (cases where the radiation field overlaps with this treatment).
3. Patients after esophageal cancer EMR or ESD.
4. Patients with an esophageal stent placed in the esophagus.
5. Cases with active simultaneous cancers requiring treatment other than superficial gastric cancer, prostate cancer, hypopharyngeal cancer, and primary lung cancer with only ground-glass opacity. Or cases with a disease-free period of less than 3 years, even if metachronous.
6. Patients with severe complications such as poorly controlled diabetes, collagen disease, interstitial pneumonia, and psychiatric disorders, who are not expected to tolerate this study protocol.
7. Patients with proven active infections and a fever of 38 degree or higher.
8. Patients who regularly use steroids.
9. Patients with other complications that are deemed to seriously impede the administration of treatment.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Keiichi |
| Middle name | |
| Last name | Jingu |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Radiation Oncology,
Zip code
9808574
Address
1-1 Seiryou-chou, Aobaku
TEL
0227177312
kjingurad@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Keiichi |
| Middle name | |
| Last name | Jingu |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Radiation Oncology
Zip code
9808574
Address
1-1 Seiryou-chou, Aobaku
TEL
022-717-7312
Homepage URL
kjingurad@yahoo.co.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Tohoku University
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
IRB Tohoku University Hospital
Address
1-1 Seryou-chou, Aobaku, Senadai
Tel
022-717-7312
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
宮城県立がんセンター (宮城県）、仙台医療センター（宮城県）、東北医科薬科大学（宮城県）、石巻赤十字病院（宮城県）、岩手県立胆沢病院（岩手県）、みやぎ県南中核病院（宮城県）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 07 | Month | 12 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 07 | Month | 22 | Day |
Anticipated trial start date
| 2024 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 06 | Month | 13 | Day |
Last modified on
| 2024 | Year | 12 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062463
