UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005042 |
|---|---|
| Receipt number | R000005974 |
| Scientific Title | Gemcitabine/TS-1 combination chemoradiotherapy for unresectable locally advanced pancreatic cancer(Phase I study) |
| Date of disclosure of the study information | 2011/02/07 |
| Last modified on | 2017/05/16 19:16:00 |
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Basic information
Public title
Gemcitabine/TS-1 combination chemoradiotherapy for unresectable locally advanced pancreatic cancer(Phase I study)
Acronym
Phase I study of CRT+GS for PC
Scientific Title
Gemcitabine/TS-1 combination chemoradiotherapy for unresectable locally advanced pancreatic cancer(Phase I study)
Scientific Title:Acronym
Phase I study of CRT+GS for PC
Region
| Japan |
Condition
Condition
Unresectable locally advanced 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 clinical safety and efficacy of Gemcitabine/TS-1 combination chemoradiotherapy and to determine the MTD for unresectable locally advanced pancreatic cancer
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I
Assessment
Primary outcomes
Safety
Key secondary outcomes
Efficacy, Median survival time (MST), Palliative efficacy
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
Gemcitabine is administered with 30 min intravenous infusion on day 1 and 8 every 3 weeks.
TS-1 60mg/m2/day is administered orally for 2 consecutive weeks every 3 weeks.
Concurrent radiotherapy (a total dose of 50.4Gy) was delivered in 28 fractions.
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
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.Histologically or cytologically confirmed advanced pancreatic cancer
2.Locally advanced pancreatic cancer is defined as the presence of a surgically unresectable tumor(involving the celiac axis or the superior mesenteric artery)
3.Performance Status:0-1(ECOG)
4.Patients of age =>20 and 75>
5.WBC>=3,500/mm3,12,000/mm3,
neutrophils >=1,500/mm3, platelets=100,000/mm3,
hemoglobin >=9.5 g/dl,
GOT </=2.0 X ULN,
GPT </=2.0 X ULN,
AL-P </=2.0 X ULN,
total bilirubin <=1.5mg/dl,
serum creatinine <=1.2mg/dl,
creatinine clearance>=50 ml/min
6.Life expectancy more than 3 months.
7.Written informed consent.
Key exclusion criteria
1.Active infection
2.Lung fibrosis or intestinal pneumoni detectable on chest X-ray and CT
3.Severe complication (heart disease, cirrhosis, diabetes)
4.Myocardial infarction within 3 months
5.Active synchronous or metachronous malignancy
6.Pregnant or lactation women, or women with known or suspected pregnancy 7.Symptomatic brain metastasis
8.history of severe drug allergy
9.Patients who are judged inappropriate for the entry into the study by the investigater
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tatsuya Ioka |
Organization
Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name
Division of Hepatobiliary and Pancreatic Oncology
Zip code
Address
3-3 Nakamichi 1cho-me, Higashinari-ku Osaka, Japan
TEL
06-6945-1181
ioka_ta@hotmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tatsuya Ioka |
Organization
Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name
Division of Hepatobiliary and Pancreatic Oncology
Zip code
Address
3-3 Nakamichi 1cho-me, Higashinari-ku Osaka, Japan
TEL
06-6945-1181
Homepage URL
ioka_ta@hotmail.com
Sponsor or person
Institute
Osaka Medical Center for Cancer and Cardiovascular Diseases
Division of Hepatobiliary and Pancreatic Oncology
Institute
Department
Personal name
Funding Source
Organization
Osaka foundation for the prevention of cancer and cardiovascular diseases
Organization
Division
Category of Funding Organization
Non profit foundation
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
| 2011 | Year | 02 | Month | 07 | 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
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
| 2006 | Year | 10 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2006 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 01 | Month | 01 | Day |
Date trial data considered complete
| 2011 | Year | 02 | Month | 01 | Day |
Date analysis concluded
| 2011 | Year | 02 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 02 | Month | 07 | Day |
Last modified on
| 2017 | Year | 05 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005974
