UMIN-CTR Clinical Trial

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Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000028626
Receipt No. R000032763
Official scientific title of the study A Prospective, Multi-Center Randomized Phase 3 Trial of Carbon Ion versus Conventional Photon Radiation Therapy for Locally Advanced, Unresectable Pancreatic
Date of disclosure of the study information 2017/08/10
Last modified on 2017/08/10

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Basic information
Official scientific title of the study A Prospective, Multi-Center Randomized Phase 3 Trial of Carbon Ion versus Conventional Photon Radiation Therapy for Locally Advanced, Unresectable Pancreatic
Title of the study (Brief title) A Randomized Phase 3 Trial of Carbon Ion versus Conventional Photon Radiation Therapy for Locally Advanced, Unresectable Pancreatic
Japan North America

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

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

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

Study type Interventional

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

No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine Device,equipment
Interventions/Control_1 Radiotherapy
Interventions/Control_2 Chemotherapy

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
Name of lead principal investigator David J. Sher
Organization University of Texas Southwestern Medical Center
Division name Department of Radiation Oncology
Address 5801 Forest Park Rd, Dallas, TX 75390
TEL 14-645-7607

Public contact
Name of contact person Shigeru Yamada, MD, PhD
Organization National Institute for Radiological Sciences (NIRS) (Japan)
Division name Department of Charged Particle Therapy
Address 4-9-1Anagawa, Inageku, Chiba
TEL 043-206-3306
Homepage URL

Institute University of Texas Southwestern Medical Center

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

Other related organizations
Name of secondary funder(s)

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


Other administrative information
Date of disclosure of the study information
2017 Year 08 Month 10 Day

Recruitment status Preinitiation
Date of protocol fixation
2017 Year 08 Month 03 Day
Anticipated trial start date
2017 Year 11 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Other related information

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

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Research Plan
Registered date File name

Research case data specifications
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Research case data
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