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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000010120
Receipt No. R000011855
Official scientific title of the study A phase I clinical trial of carbon ion radiotherapy and concurrent gemcitabine
Date of disclosure of the study information 2013/02/26
Last modified on 2016/11/04

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Basic information
Official scientific title of the study A phase I clinical trial of carbon ion radiotherapy and concurrent gemcitabine
Title of the study (Brief title) Preoperative carbon ion radiotherapy and chemothrapy for patients with preoperative
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 To establish the safety of preoperative carbon ion radiotherapy and chemothrapy for patients with preoperative pancreatic cancer.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase I

Assessment
Primary outcomes Acute toxicity of organ at risks
Key secondary outcomes Primary response rate by recommended dose in 6 months after treatment

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
Medicine
Interventions/Control_1 2 weeks Carbon ion radiotherapy: 36.8 GyE / 8 fractions
Chemotherapy: weekly gemcitabine 1000 mg / m2 for 3 weeks.
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

Not applicable
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria 1)Union for International Cancer Control (UICC) StageI- IIB invasive ductal carcinomas of the pancreas
2)Pathologically confirmed invasive ductal carcinomas
3)Patients with no histories of prior chemotherapy or pelvic radiotherapy for pancreasl cancer
4)Tumor size <= 15cm
5)The tumor had to be grossly measurable.
6)Age <= 80 years
7)Performance status 0 - 1
8)Normal organ function
WBC >= 4000/mm3
neutrophil>= 2000/mm3
Hb >= 9.0g/dl
Plt>= 100,000/mm3
T-Bil.<= 3.0mg/dl,
AST(GOT) and ALT(GPT) <= 100IU/dl
Cre <= 1.2mg/dl
9)Written informed consent
Key exclusion criteria 1)History of abdominal radiotherapy
2)Metallic stent for obstructive jaundice
3)Digestive tracts invasion
4)Severe complicating illness
5)Histoly of other malignancies within 2 years
6)Active and Severe infection
7)medical, psychological or others reason that primary doctor think ineligible
Target sample size 10

Research contact person
Name of lead principal investigator Shigeru Yamada
Organization National Institute of Radiological Sciences
Division name Research Center Hospital for Charged Particle Therapy
Address 4-9-1 Anagawa, Inage-ku, Chiba-city, Chiba, 263-8555 JAPAN
TEL 043-206-3306
Email yamada.shigeru@qst.go.jp

Public contact
Name of contact person Shigeru Yamada
Organization National Institute of Radiological Sciences
Division name Research Center Hospital for Charged Particle Therapy
Address 4-9-1 Anagawa, Inage-ku, Chiba-city, Chiba, 263-8555 JAPAN
TEL 043-206-3306
Homepage URL http://www.nirs.go.jp/hospital/index.shtml
Email yamada.shigeru@qst.go.jp

Sponsor
Institute Research Center Hospital for Charged Particle Therapy
National Institute of Radiological Sciences
Institute
Department

Funding Source
Organization National Institute of Radiological Sciences
Organization
Division
Category of Funding Organization Government offices of other countries
Nationality of Funding Organization

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

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
2013 Year 02 Month 26 Day

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2012 Year 05 Month 08 Day
Anticipated trial start date
2012 Year 05 Month 08 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
Results
Other related information

Management information
Registered date
2013 Year 02 Month 26 Day
Last modified on
2016 Year 11 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011855

Research Plan
Registered date Registrant File name

Research case data specifications
Registered date Registrant File name

Research case data
Registered date Registrant File name


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