UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004422 |
|---|---|
| Receipt number | R000005282 |
| Scientific Title | Preoperative chemoradiation therapy combined with peptide vaccination for T3-pancreatic cancer: prospective phase I/II study |
| Date of disclosure of the study information | 2010/10/20 |
| Last modified on | 2018/04/26 09:06:26 |
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Basic information
Public title
Preoperative chemoradiation therapy combined with peptide vaccination for T3-pancreatic cancer: prospective phase I/II study
Acronym
Preoperative multimodal treatment for pancreatic cancer
Scientific Title
Preoperative chemoradiation therapy combined with peptide vaccination for T3-pancreatic cancer: prospective phase I/II study
Scientific Title:Acronym
Preoperative multimodal treatment for pancreatic cancer
Region
| Japan |
Condition
Condition
T3(UICC)-pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety and efficacy of preoperative chemoradiation therapy combined with peptide vaccination for resectable pancreatic cancer patient.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase I,II
Assessment
Primary outcomes
Safety
Disease free survival
Key secondary outcomes
Overall survival,
Histopathological and immunological response, pattern of recurrence
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
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 |
Interventions/Control_1
Preoperative gemcitabine-based chemoradiation therapy with peptide vaccination
Interventions/Control_2
Preoperative gemcitabine-based chemoradiation therapy without peptide vaccination
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
| 20 | years-old | <= |
Age-upper limit
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Resectable Pancreatic cancer ; T3 of UICC TNM classification of malignant tumours 7th edition). Histological or cytological confirmation as pancreatic adenocarcinoma
is required. No contraindication for gemcitabine-based chemoradiation therapy.
Key exclusion criteria
Liver, renal dysfunction, severe coronary disease.
Unresectable pancreatic cancer, including borderline resectable cases.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hidenori Takahashi |
Organization
Osaka Medical Center for Cancer & Cardiovascular Diseases
Division name
Department of Gastroenterological surgery
Zip code
Address
1-3-3, Nakamichi, Higashinari-ku, Osaka, 537-8511, Japan
TEL
06-6945-1181
takahasi-hi@mc.pref.osaka.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hidenori Takahashi |
Organization
Osaka Medical Center for Cancer & Cardiovascular Diseases
Division name
Department of Gastroenterological surgery
Zip code
Address
1-3-3, Nakamichi, Higashinari-ku, Osaka, 537-8511, Japan
TEL
06-6972-1181
Homepage URL
takahasi-hi@mc.pref.osaka.jp
Sponsor or person
Institute
Department of Gastroenterological Surgery, Osaka Medical Center for cancer & Cardiovascular Diseases
Institute
Department
Personal name
Funding Source
Organization
Osaka Medical Center for cancer & Cardiovascular Diseases
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Human Genome Center, Institute of Medical Science, University of Tokyo
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
| 2010 | Year | 10 | Month | 20 | 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
No longer recruiting
Date of protocol fixation
| 2010 | Year | 04 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 06 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 10 | Month | 20 | Day |
Last modified on
| 2018 | Year | 04 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005282
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
