UMIN-CTR Clinical Trial

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
Email	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
Email	reirei513@hotmail.com

Sponsor
Institute	Tohoku University
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051117