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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000745
Receipt No. R000000896
Scientific Title Phase I Radiation Dose Escalation Study using Four-dimensional Intensity Modulated Radiation Therapy for Locally Advanced Pancreatic Cancer
Date of disclosure of the study information 2007/06/21
Last modified on 2012/01/26

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Basic information
Public title Phase I Radiation Dose Escalation Study using Four-dimensional Intensity Modulated Radiation Therapy for Locally Advanced Pancreatic Cancer
Acronym 4DIMRT-PI for LA-Pancreatic Cancer
Scientific Title Phase I Radiation Dose Escalation Study using Four-dimensional Intensity Modulated Radiation Therapy for Locally Advanced Pancreatic Cancer
Scientific Title:Acronym 4DIMRT-PI for LA-Pancreatic Cancer
Region
Japan

Condition
Condition Locally advanced pancreatic cancer
Classification by specialty
Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To investigate the safety and efficacy of 4D-IMRT with S-1 for locally advanced pancreatic cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase I

Assessment
Primary outcomes Dose limiting toxicities
GI toxicities
Hematologic toxicities
Key secondary outcomes Survival
Local control
Response rate
Time to develop metastases

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine Maneuver
Interventions/Control_1 Radiation dose escalation
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. Written informed consent
2. Age <= 80 years old
3. KPS >= 70
4. No previous Tx for pancreatic cancer
5. Possible oral intake
6. No major systemic organ problem
7. UICC Stage III
Key exclusion criteria 1. Gastric pr duodenal ulcer
2. Use of phenitoin, walfalin potasium, flusitosin
3. Plural effusion, ascitis
4. Active infection
5. Major comorbidities
6. Congnitive deterioration
7. Allegy to drug
8. Pregnancy
9. If doctor judged not feasible to enroll
Target sample size 24

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hidefumi Aoyama
Organization Hokkaido University Hospital
Division name Radiology
Zip code
Address North 14, West 5, Sapporo, Japan
TEL 011-706-5977
Email

Public contact
Name of contact person
1st name
Middle name
Last name Hidefumi Aoyama
Organization Hokkaido University Hospital
Division name Radiology
Zip code
Address
TEL 011-716-1161
Homepage URL
Email

Sponsor
Institute Hokkaido University Hospital
Dept. of Radiology
Dept. of Internal Medicine
Dept. of Medical Oncology
Dept. of Surgical Oncology
Institute
Department

Funding Source
Organization Not applicable
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
Address
Tel
Email

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
2007 Year 06 Month 21 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
2007 Year 06 Month 13 Day
Date of IRB
Anticipated trial start date
2007 Year 06 Month 01 Day
Last follow-up date
2010 Year 03 Month 01 Day
Date of closure to data entry
2010 Year 03 Month 01 Day
Date trial data considered complete
2010 Year 03 Month 01 Day
Date analysis concluded
2010 Year 03 Month 01 Day

Other
Other related information

Management information
Registered date
2007 Year 06 Month 21 Day
Last modified on
2012 Year 01 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000896

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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