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UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000001990
Receipt No. 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

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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
Email 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
Email ioka-ta@mc.pref.osaka.jp

Sponsor
Institute Osaka Medical Center for Cancer and Cardiovascular Diseases
Department of Medical Oncology
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002421

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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