UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001990 |
|---|---|
| Receipt number | R000002421 |
| Scientific Title | Randomized phase II study comparing Gemcitabine/TS-1 combination chemoradiotherapy with Gemcitabine/TS-1 combination chemotherapy for unresectable locally advanced pancreatic cancer. |
| Date of disclosure of the study information | 2009/05/22 |
| Last modified on | 2017/05/16 19:11:46 |
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Basic information
Public title
Randomized phase II study comparing Gemcitabine/TS-1 combination chemoradiotherapy with Gemcitabine/TS-1 combination chemotherapy for unresectable locally advanced pancreatic cancer.
Acronym
Randomized phase II study comparing Gemcitabine/TS-1 combination chemoradiotherapy with Gemcitabine/TS-1 combination chemotherapy for unresectable locally advanced pancreatic cancer.
Scientific Title
Randomized phase II study comparing Gemcitabine/TS-1 combination chemoradiotherapy with Gemcitabine/TS-1 combination chemotherapy for unresectable locally advanced pancreatic cancer.
Scientific Title:Acronym
Randomized phase II study comparing Gemcitabine/TS-1 combination chemoradiotherapy with Gemcitabine/TS-1 combination chemotherapy for unresectable locally advanced pancreatic cancer.
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 effectiveness of Gemcitabine/TS-1 combination chemoradiotherapy with Gemcitabine /TS-1 combination chemotherapy for unresectable locally advanced pancreatic cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Two year survival rate
Key secondary outcomes
Progression free survival(PFS)
Overall Survival(OS)
Adverse events
Response rate
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Group A : Gemcitabine 1,000mg/m2 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.
Interventions/Control_2
Group B : Gemcitabine 600mg/m2 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.
Maintenance TS-1+ Gemcitabine combination chemoradiotherapy was administered.
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 or cytologically confirmed adenocarcinoma, adenocarcinoma squamous carcinoma of pancreatic cancer.
2. Patients who confirmed unresectable locally advanced pancreatic cancer with the criteria below.
a: Involving over 1/2 circumference of major artery (SMA/CA). (Under 1/2 that was borderline lesion.)
b: Involving over the merging section of portal-SMV.
c: No distal metastasis with diagnostic imaging.
d: Confirmed by CT image performed with in four weeks before registration.
3. Performance Status:0-1(ECOG)
4. Patients of age =>20 and 80>
5. Sufficient organ functions.
(1) neutrophils >=1,500/mm3
(2) platelets >=100,000/mm3
(3) hemoglobin >=9.0g/dl
(4) AST(GOT)/ALT(GPT) <=150IU
(5) total bilirubin <=2.0mg/dl
(or <=3.0mg/dl if biliary drainage were present)
(6) serum creatinine <=1.2mg/dl
(7) creatinine clearance>=60ml/min
6. Life expectancy more than 3 months.
7. Written informed consent.
Key exclusion criteria
1) Lung fibrosis or intestinal pneumoni, and anamnesis or imaging findings.
2) Watery diarrhea
3) Severe infection
4) Severe complication
(heart failure, renal failure, hepatic insufficiency,hemorrhagic peptic ulcer, intestines paralysis,ileus or uncontrolled diabetes etc)
5) Massive pleural or abdominal effusion.
6) Metastasis to central nervous system.
7) Active synchronous or metachronous malignancy other than carcinoma in situ.
8) Regular use of frucitocin, fenitoin or warfarin
9) Pregnant or lactation women, or women with known or suspected pregnancy and men who want let to pregnancy
10) Severe mental illness
11) Patients who are judged inappropriate for the entry into the study by the investigater.
Target sample size
110
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
Department of Medical Oncology
Zip code
Address
3-3 Nakamichi 1cho-me, Higashinari-ku Osaka, Japan
TEL
06-6972-1181
ioka-ta@mc.pref.osaka.jp
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
Department of Medical Oncology
Zip code
Address
3-3 Nakamichi 1cho-me, Higashinari-ku Osaka, Japan
TEL
06-6972-1181
Homepage URL
ioka-ta@mc.pref.osaka.jp
Sponsor or person
Institute
Osaka Medical Center for Cancer and Cardiovascular Diseases
Department of Medical Oncology
Institute
Department
Personal name
Funding Source
Organization
Osaka foundation for the prevention of cancer and cardiovascular diseases data center
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
YES
Study ID_1
NCT01430052
Org. issuing International ID_1
ClinicalTrials.gov
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
大阪府立成人病センター(大阪府）、神戸大学(兵庫県）、杏林大学（東京都）、関西医科大学枚方病院（大阪府）、国立病院機構大阪医療センター（大阪府）、神奈川県立がんセンター（神奈川県）、東京女子医科大学（東京都）、
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 05 | Month | 22 | 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
Main results already published
Date of protocol fixation
| 2009 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
| 2014 | Year | 06 | Month | 04 | Day |
Date trial data considered complete
| 2014 | Year | 06 | Month | 04 | Day |
Date analysis concluded
| 2015 | Year | 05 | Month | 10 | Day |
Other
Other related information
Management information
Registered date
| 2009 | Year | 05 | Month | 21 | 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=R000002421
