UMIN-CTR Clinical Trial

Basic information
Public title	Prospective cohort study to evaluate feasibility and efficacy of systemic chemotherapy followed by carbon-ion radiotherapy for unresectable locally advanced pancreatic cancer
Acronym	Yu-PANC-01
Scientific Title	Prospective cohort study to evaluate feasibility and efficacy of systemic chemotherapy followed by carbon-ion radiotherapy for unresectable locally advanced pancreatic cancer
Scientific Title:Acronym	Yu-PANC-01
Region	Japan

Condition
Condition	Unresectable locally-advanced pancreatic cancer
Classification by specialty	Hepato-biliary-pancreatic medicine Hepato-biliary-pancreatic surgery Radiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the feasibility and efficacy of systemic chemotherapy followed by carbon-ion radiotherapy for unresectable locally-advanced pancreatic cancer.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Disease control rate for 6 months with systemic chemotherapy followed by carbon-ion radiotherapy
Key secondary outcomes	Response rate, Tumor reduction rate, Tumor marker kinetics during the therapy, Overall survival, Progression-free survival, Adverse events, Dose intensity of the agents.

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	79 years-old >=
Gender	Male and Female
Key inclusion criteria	1. Histological or cytological confirmation of malignancy. 2. Radiologically diagnosed as pancreatic ductal adenocarcinoma. 3. Unresectable locally-advanced (UR-LA) or Borderline resectable with arterial abutment (BR-A), confirmed by CT-imaging. 4. No obvious distant metastatic findings. 5. Age of over 17 and under 80. 6. Performance status is 0 or 1 (ECOG). 7. Measurable disease. 8. Chemotherapy or Radiotherapy naive for pancreatic cancer. 9. Able to eat orally. 10. No serious comorbidity. 11. No active and ongoing other malignancy. 12. No pregnancy, planing pregnancy or baby. 13. No peripheral neuropathy. 14. Written informed consent.
Key exclusion criteria	1. No histological or cytological confirmation of malignancy. 2. Resectable (R) or Borderline resectable without arterial abutment (BR-PV). 3. Radiological distant metastases. 4. Age of under 18 or over 79. 5. Performance status is 2 or 3 (ECOG). 6. No measurable disease. 7. Previous treatment with chemotherapy or radiotherapy for pancreatic cancer. 8. Unable to eat orally. 9. Serious comorbidity. 10. Active and ongoing other malignancy. 11. Pregnancy, planing pregnancy or baby. 12. Peripheral neuropathy.
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Motoi Middle name Last name Fuyuhiko
Organization	Yamagata University
Division name	Department of Surgery I
Zip code	990-9585
Address	2-2-2, Iida-Nishi, Yamagata
TEL	023-628-5334
Email	fmotoi@med.id.yamagata-u.ac.jp

Public contact
Name of contact person	1st name Motoi Middle name Last name Fuyuhiko
Organization	Yamagata University
Division name	Department of Surgery I
Zip code	990-9585
Address	2-2-2, Iida-Nishi, Yamagata
TEL	023-628-5334
Homepage URL	http://www.surgery1-yamagata.net/index.html
Email	fmotoi@med.id.yamagata-u.ac.jp

Sponsor
Institute	Faculty of Medicine, Yamagata University
Institute
Department

Funding Source
Organization	Faculty of Medicine, Yamagata 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	The ethic review committee of facluty of medicine, Yamagata University
Address	2-2-2, Iida-Nishi, Yamagata
Tel	023-633-1122
Email	yu-ikekenkyu@jm.kj.yamagata-u.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	2022 Year 11 Month 08 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	Enrolling by invitation
Date of protocol fixation	2022 Year 10 Month 24 Day
Date of IRB	2022 Year 10 Month 27 Day
Anticipated trial start date	2022 Year 11 Month 08 Day
Last follow-up date	2027 Year 12 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Definition of "Disease Control" (after more than 6 months.) 1) CR or PR or SD (without any new lesion) by RECIST criteria. 2) Tumor marker decrease after treatment.

Management information
Registered date	2022 Year 11 Month 08 Day
Last modified on	2022 Year 11 Month 08 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055475