UMIN-CTR Clinical Trial

Basic information
Public title	A Prospective, Multi-Center Randomized Phase 3 Trial of Carbon Ion versus Conventional Photon Radiation Therapy for Locally Advanced, Unresectable Pancreatic
Acronym	A Randomized Phase 3 Trial of Carbon Ion versus Conventional Photon Radiation Therapy for Locally Advanced, Unresectable Pancreatic
Scientific Title	A Prospective, Multi-Center Randomized Phase 3 Trial of Carbon Ion versus Conventional Photon Radiation Therapy for Locally Advanced, Unresectable Pancreatic
Scientific Title:Acronym	A Randomized Phase 3 Trial of Carbon Ion versus Conventional Photon Radiation Therapy for Locally Advanced, Unresectable Pancreatic
Region	Japan North America

Condition
Condition	Locally Advanced, Unresectable Pancreatic Cancer
Classification by specialty	Radiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To compare the efficacy of carbon ion-based chemoradiotherapy with x-ray-based chemoradiotherapy for the treatment of locally advanced pancreatic adenocarcinoma by comparison of overall survival at 2 years following treatment.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	2 years overall survival, defined from the date of randomization to death
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine Device,equipment
Interventions/Control_1	Radiotherapy
Interventions/Control_2	Chemotherapy
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	Male and Female
Key inclusion criteria	1.All patients must be willing and capable to provide informed consent to participate in the protocol. 2.Histological and/or cytological diagnosis of pancreas adenocarcinoma within 60 days of registration 3.Unresectable by radiographic or exploration within 30 days of registration 4.Age =or > 18 years. 5.Distance from the pancreas tumor edge to the bowel and stomach > 3 mm (in both the prone and supine positions) 6.Tumor does not exceed 15 cm in greatest dimension 7.No evidence for metastatic disease as assessed by CT imaging of the chest, abdomen a8.Zubrod performance status of 0-1, within 30 days prior to registration (Appendix B) 9.MP and CBC with differential obtained within 14 days prior to registration (may be taken after stent placement), with adequate hematologic variables as defined by: Absolute neutrophil count > 1500 cells/mm3 Creatinine <1.5 mg/dL Hemoglobin >8.0 g/dL AST and ALT < 2.5 X ULN Bilirubin < 1.5 times the ULN (after stent placement, if necessary) 10.Patients must complete all required pretreatment evaluations (section 5.0) 11.Able to travel to a foreign country within approximately 2 weeks of randomization (for patients enrolled at UTSW) 12. Women of childbearing potential and male participants must agree to use an effective method of contraception. 1 A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria: Has not undergone a hysterectomy or bilateral oophorectomy; or Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).
Key exclusion criteria	1.Subjects receiving other investigational agents. 2.History of allergic reactions attributed to compounds of similar chemical or biologic composition to gemcitabine or nab-paclitaxel or other agents used in study. 3.Subjects who are pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants. 4.Prior treatment for pancreatic cancer preceding registration 5.Prior radiation to the upper abdomen 6.Placement of a metal stent for relief of biliary obstruction (metal stents may be placed following completion of radiation therapy). 7.Body weight >100 kg 8.Active inflammatory bowel disease or active gastric/duodenal ulcer 9.Metal implants in the upper abdomen 10.Expected medical intolerance of radiotherapy, concurrent chemotherapy, and/or adjuvant chemotherapy. 11.History of HIV or hepatitis B or C
Target sample size	103

Research contact person
Last name of lead principal investigator	1st name Middle name Last name David J. Sher
Organization	University of Texas Southwestern Medical Center
Division name	Department of Radiation Oncology
Zip code
Address	5801 Forest Park Rd, Dallas, TX 75390
TEL	14-645-7607
Email	David.Sher@UTSouthwestern.edu

Public contact
1st name of contact person	1st name Middle name Last name Shigeru Yamada, MD, PhD
Organization	National Institute for Radiological Sciences (NIRS) (Japan)
Division name	Department of Charged Particle Therapy
Zip code
Address	4-9-1Anagawa, Inageku, Chiba
TEL	043-206-3306
Homepage URL
Email	yamada.shigeru@qst.go.jp

Sponsor
Institute	University of Texas Southwestern Medical Center
Institute
Department

Funding Source
Organization	University of Texas Southwestern Medical Center
Organization
Division
Category of Funding Organization	Outside Japan
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs	YES
Study ID_1	17-015
Org. issuing International ID_1	National INstitute for Quantum and Radiological Science and Technology
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2017 Year 08 Month 10 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	Completed
Date of protocol fixation	2017 Year 08 Month 03 Day
Date of IRB	2019 Year 03 Month 01 Day
Anticipated trial start date	2019 Year 03 Month 27 Day
Last follow-up date	2023 Year 02 Month 27 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	This trial has moved from UMIN to JRCT.

Management information
Registered date	2017 Year 08 Month 10 Day
Last modified on	2019 Year 03 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032763