UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044754 |
|---|---|
| Receipt number | R000051117 |
| Scientific Title | Phase I clinical trial to examine the safety of stereotactic radiotherapy including subclinical regions for pancreatic cancer |
| Date of disclosure of the study information | 2021/07/07 |
| Last modified on | 2021/07/07 17:12:56 |
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Basic information
Public title
Phase I clinical trial to examine the safety of stereotactic radiotherapy including subclinical regions for pancreatic cancer
Acronym
Clinical trial of stereotactic radiotherapy including subclinical regions for pancreatic cancer
Scientific Title
Phase I clinical trial to examine the safety of stereotactic radiotherapy including subclinical regions for pancreatic cancer
Scientific Title:Acronym
Clinical trial of stereotactic radiotherapy including subclinical regions for pancreatic cancer
Region
| Japan |
Condition
Condition
Pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim is to examine the maximum tolerated dose and recommended dose of stereotactic radiotherapy including subclinical region for pancreatic cancer based on the severity and frequency of adverse events.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase I
Assessment
Primary outcomes
Frequency of acute toxicities within 14 days after the complete of stereotactic radiotherapy.
Key secondary outcomes
Frequency of subacute and late toxicities, Overall survival rate, Progression-free survival 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
Stereotactic 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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Borderline resectable or unresectable pancreatic cancer (with or without prior chemotherapy, with or without regional lymph node metastasis)
(2) Histologically or cytologically proven adenocarcinoma
(3) Maximum tumor diameter is 5 cm or less
(4) No obvious invasion to gastrointestinal organs such as stomach and duodenum.
(5) Aged 20 to 80 years old
(6) ECOG PS of 0 or 1
(7) No previous history of surgical resection for pancreatic cancer
(8) No previous history of chemotherapy or radiation therapy for abdominal malignancy
(9) Adequate organ functions
(10) Written informed consent
Key exclusion criteria
(1) A metallic stent has been inserted in the bile duct and duodenum.
(2) Peritoneal dissemination has been confirmed by peritoneal cytology within 4 weeks prior to enrollment.
(3) Cases with severe complication such as heart disease, renal disease, and hepatic disease
(4) Fever over 38 degrees Celsius
(5) Other active malignancy at the start of our study
(6) Patients requiring systemic steroids medication or other immunosuppressants
(7) Patients who can' t receive neither iodic drug nor gadolinium because of drug allergy
(8) Cases with severe psychological disorder
(9) Other cases that were judged to be inappropriate for conducting this study
Target sample size
18
Research contact person
Name of lead principal investigator
| 1st name | Rei |
| Middle name | |
| 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 | |
| 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
Not applicable
Organization
Division
Category of Funding Organization
Other
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
| 2021 | Year | 07 | Month | 07 | 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
| 2021 | Year | 07 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2021 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2025 | 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
| 2021 | Year | 07 | Month | 04 | Day |
Last modified on
| 2021 | Year | 07 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051117
