UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002649 |
|---|---|
| Receipt number | R000003226 |
| Scientific Title | Phase I/II study of preoperative chemoradiotherapy with Gemcitabine and S-1 for resectable pancreatic cancer |
| Date of disclosure of the study information | 2009/10/19 |
| Last modified on | 2020/04/27 09:14:19 |
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Basic information
Public title
Phase I/II study of preoperative chemoradiotherapy with Gemcitabine and S-1 for resectable pancreatic cancer
Acronym
Phase I/II study of preoperative chemoradiotherapy with Gemcitabine and S-1 for resectable pancreatic cancer
Scientific Title
Phase I/II study of preoperative chemoradiotherapy with Gemcitabine and S-1 for resectable pancreatic cancer
Scientific Title:Acronym
Phase I/II study of preoperative chemoradiotherapy with Gemcitabine and S-1 for resectable pancreatic cancer
Region
| Japan |
Condition
Condition
resectable pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety and feasibility, to determine recommended dose (RD) and to evaluate the efficacy of preoperative chemoradiotherapy with Gemcitabine and S-1 in patients with resectable pancreatic cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Phase 1: Dose limiting toxicity, maximum tolerated dose, recommended dose
Phase 2: Pathological effect
Key secondary outcomes
Response rate, Safety, Curative resection rate, Feasibility, Local recurrence rate, Relapse free survival (RFS), Overall survival (OS)
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
preoperative 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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Histologically proven pancreatic adenocarcinoma
(2) Age between 20 and 80 years
(3) ECOG performance status of 0 or 1
(4) Surgically resectable
(5) Life Expectancy must be >=6 months
(6) Adequate hematologic, hepatic, renal and respiratory function
(7) Interval of at least 4 weeks between prior treatment and start of present study
(8) Written informed consent
Key exclusion criteria
(1) Unresectable 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
55
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 Clinical Research Review Committee
Address
2-2 Yamadaoka Suita, Osaka 565-0871, Japan
Tel
06-6210-8296
handai-nintei@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
| 2009 | Year | 10 | Month | 19 | 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
63
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
| 2009 | Year | 10 | Month | 15 | Day |
Date of IRB
| 2009 | Year | 10 | Month | 15 | Day |
Anticipated trial start date
| 2009 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 08 | Month | 31 | Day |
Date trial data considered complete
| 2020 | Year | 08 | Month | 31 | Day |
Date analysis concluded
| 2021 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2009 | Year | 10 | Month | 19 | Day |
Last modified on
| 2020 | Year | 04 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003226
| Research Plan | |
|---|---|
| Registered date | File name |
| 2014/12/24 | CSGO-HBP-003_切除可能GSRT_プロトコル.docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2014/12/24 | CSGO-HBP-003_切除可能GSRT_CRF.doc |
| Research case data | |
|---|---|
| Registered date | File name |
