UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Randomized phase II study comparing Gemcitabine/TS-1 combination chemoradiotherapy with Gemcitabine/TS-1 combination chemotherapy for unresectable locally advanced pancreatic cancer.
Title of the study (Brief title)	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	Tatsuya Ioka
Organization	Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name	Department of Medical Oncology
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	Tatsuya Ioka
Organization	Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name	Department of Medical Oncology
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)

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

Progress
Recruitment status	Main results already published
Date of protocol fixation	2009 Year 04 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000002421