UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000745 |
|---|---|
| Receipt number | 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 16:49:19 |
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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
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
Sponsor or person
Institute
Hokkaido University Hospital
Dept. of Radiology
Dept. of Internal Medicine
Dept. of Medical Oncology
Dept. of Surgical Oncology
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000896
