UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014894 |
|---|---|
| Receipt number | R000015533 |
| Scientific Title | Randomized phase II trial of chemoradiotherapy with S-1 versus gemcitabine and S-1 combination therapy as neoadjuvant treatment in patients with resecatble pancreatic cancer |
| Date of disclosure of the study information | 2014/08/19 |
| Last modified on | 2020/02/22 12:04:53 |
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Basic information
Public title
Randomized phase II trial of chemoradiotherapy with S-1 versus gemcitabine and S-1 combination therapy as neoadjuvant treatment in patients with resecatble pancreatic cancer
Acronym
Randomized phase II trial of chemoradiotherapy with S-1 versus gemcitabine and S-1 combination therapy as neoadjuvant treatment in patients with resecatble pancreatic cancer (JASPAC 04)
Scientific Title
Randomized phase II trial of chemoradiotherapy with S-1 versus gemcitabine and S-1 combination therapy as neoadjuvant treatment in patients with resecatble pancreatic cancer
Scientific Title:Acronym
Randomized phase II trial of chemoradiotherapy with S-1 versus gemcitabine and S-1 combination therapy as neoadjuvant treatment in patients with resecatble pancreatic cancer (JASPAC 04)
Region
| Japan |
Condition
Condition
resectable pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery | Radiology |
| Operative medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of chemoradiotherapy with S-1 or gemcitabine and S-1 combination therapy as neoadjuvant treatment in patients with resectable pancreatic cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase II
Assessment
Primary outcomes
2-year progression-free survival
Key secondary outcomes
overall survaival (2-year survival rate), R0 or 1 resection rate, pathological response rate, adverse event of neoadjuvant therapy, morbidity rate of surgery, non-hematologic adverse event of grade 4, early mortality rate, treatment-related mortality rate
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine | Maneuver |
Interventions/Control_1
chemoradiotherapy with S-1 as neoadjuvant treatment
Interventions/Control_2
Gemcitabine and S-1 combination therapy as neoadjuvant treatment
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
| 79 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1 Invasive ductal adenocarcinoma of the pancreas based on the images,
2 Adenocarcinoma is proven by biopsy or cytology,
3 Radiation field for the primary lesion and lymph node metastasis is lemited within 10 cm,
4 No gastric or duodenal ulcer
5 No cancerous invasion into stomach or duodenum, etc
Key exclusion criteria
1 Treatment history with gemcitabine or fuluoruracil,
2 Use of flucytosine, phenytoin, and warfarin potassium,
3 Fibroid lung or interstitial pneumonia,
4 Pleural lung or ascites
5 Watery diarrhea, etc
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | KATSUHIKO |
| Middle name | |
| Last name | UESAKA |
Organization
Shizuoka Cancer Center Hospital
Division name
Division of Hepato-Biliary-Pancreatic Surgery
Zip code
411-8777
Address
1007, Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, 411-8777 JAPAN
TEL
055-989-5222
k.uesaka@scchr.jp
Public contact
Name of contact person
| 1st name | KATSUHIKO |
| Middle name | |
| Last name | UESAKA |
Organization
Shizuoka Cancer Center Hospital
Division name
Division of Hepato-Biliary-Pancreatic Surgery
Zip code
411-8777
Address
1007, Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, 411-8777 JAPAN
TEL
055-989-5222
Homepage URL
k.uesaka@scchr.jp
Sponsor or person
Institute
Japan Adjuvant Study Group of Pancreatic Cancer (JASPAC)
Institute
Department
Personal name
Funding Source
Organization
Shizuoka Organization for Creation of Industries, Pharma Valley Center
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board, Shizuoka Cancer Center
Address
1007, Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, 411-8777 JAPAN
Tel
055-989-5222
k.goto@scchr.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
静岡県立静岡がんセンター (Shizuoka Cancer Center Hospital)、他(etc)
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 08 | Month | 19 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
103
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
Main results already published
Date of protocol fixation
| 2012 | Year | 02 | Month | 14 | Day |
Date of IRB
| 2013 | Year | 03 | Month | 26 | Day |
Anticipated trial start date
| 2013 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 08 | Month | 19 | Day |
Last modified on
| 2020 | Year | 02 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015533
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