UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011453 |
|---|---|
| Receipt number | R000013409 |
| Scientific Title | Prospective study of chemoradiotherapy with gemcitabine and S-1 for borderline resectable or unresectable pancreatic cancer |
| Date of disclosure of the study information | 2013/08/11 |
| Last modified on | 2024/05/10 14:41:11 |
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Basic information
Public title
Prospective study of chemoradiotherapy with gemcitabine and S-1 for borderline resectable or unresectable pancreatic cancer
Acronym
Prospective study of chemoradiotherapy with gemcitabine and S-1 for borderline resectable or unresectable pancreatic cancer
Scientific Title
Prospective study of chemoradiotherapy with gemcitabine and S-1 for borderline resectable or unresectable pancreatic cancer
Scientific Title:Acronym
Prospective study of chemoradiotherapy with gemcitabine and S-1 for borderline resectable or unresectable pancreatic cancer
Region
| Japan |
Condition
Condition
pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy, safety and feasibility of chemoradiotherapy with gemcitabine and S-1 in patients with borderline resectable or unresectable pancreatic cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1-year overall survival (OS)
Key secondary outcomes
response rate, overall survival (OS), relapse free survival (RFS), progression free survival (PFS), feasibility, curative resection rate
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
chemoradiotherapy with gemcitabine and S-1
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Histologically, radiologically or serologically diagnosed pancreatic adenocarcinoma
(2) Borderline resectable or unresectable pancreatic cancer with measurable lesion
(3) No prior treatment for pancreatic cancer
(4) Age of 20 and more
(5) ECOG performance status of 0 or 1
(6) Adequate hematologic, hepatic, renal and respiratory function
(7) Orally feedable
(8) Clinically normal electrocardiogram
(9) Written informed consent
Key exclusion criteria
(1) Resectable pancreatic cancer
(2) Presence or past history of Interstitial pneumonia or pulmonary fibrosis or possible
(3) Watery diarrhea
(4) Active infections (excluding viral hepatitis)
(5) Severe cardiac disorder, renal disorder, liver disorder, ulcer with bleeding, intestinal tract paralysis, uncontrollable diabetes mellitus
(6) Presence of pleural effusion or ascites requiring drainage
(7) Presence of metastasis in central nervous system
(8) Active double cancer except carcinoma in situ or intramucosal cancer (synchronous double cancer or asynchronous double cancer with disease-free duration to be within 3 years)
(9) Treatment with phenytoin, potassium warfarin or flucytosine
(10) Pregnant females or nursing mothers who can not stop lactation. Patients or partners, who don't attempt to doing contraception during the study period.
(11) Severe mental disorder
(12) Severe drug hypersensitivity
(13) As determined by the principal investigator or the sub-investigator the subject is not adequate to participate in the trial
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Hidetoshi |
| Middle name | |
| Last name | Eguchi |
Organization
Osaka University
Division name
Gastroenterological Surgery
Zip code
565-0871
Address
2-2 Yamadaoka, Suita, Osaka, Japan
TEL
06-6879-3251
heguchi@gesurg.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Hidetoshi |
| Middle name | |
| Last name | Eguchi |
Organization
Osaka University
Division name
Gastroenterological Surgery
Zip code
565-0871
Address
2-2 Yamadaoka, Suita, Osaka, Japan
TEL
06-6879-3251
Homepage URL
heguchi@gesurg.med.osaka-u.ac.jp
Sponsor or person
Institute
Multicenter Clinical Study Group of Osaka
Institute
Department
Personal name
Funding Source
Organization
None (Self-funding)
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
Osaka University Hospital Academic Clinical Research Center
Address
2-15 Yamadaoka Suita, Osaka Japan
Tel
06-6879-5685
rinri@hp-crc.med.osaka-u.ac.jp
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 | 08 | Month | 11 | Day |
Related information
URL releasing protocol
unpublished
Publication of results
Unpublished
Result
URL related to results and publications
unpublished
Number of participants that the trial has enrolled
50
Results
unpublished
Results date posted
| 2024 | Year | 02 | Month | 27 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
UR-LA pancreatic cancer
Participant flow
UR-LA pancreatic cancer
Adverse events
analyzing
Outcome measures
analyzing
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2013 | Year | 06 | Month | 19 | Day |
Date of IRB
| 2013 | Year | 06 | Month | 19 | Day |
Anticipated trial start date
| 2013 | Year | 06 | Month | 19 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 08 | Month | 11 | Day |
Last modified on
| 2024 | Year | 05 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013409
