Unique ID issued by UMIN | UMIN000003496 |
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Receipt number | R000004219 |
Scientific Title | Multicenter Phase II study of TS-1 and gemcitabine combination therapy for elderly patients with unresectable pancreatic cancer. |
Date of disclosure of the study information | 2010/04/15 |
Last modified on | 2012/04/05 17:07:13 |
Multicenter Phase II study of TS-1 and gemcitabine combination therapy for elderly patients with unresectable pancreatic cancer.
TS-1/gemcitabine regimen in elderly patients with pancreatic cancer.
Multicenter Phase II study of TS-1 and gemcitabine combination therapy for elderly patients with unresectable pancreatic cancer.
TS-1/gemcitabine regimen in elderly patients with pancreatic cancer.
Japan |
Elderly patients with unresectable pancreatic cancer
Hepato-biliary-pancreatic medicine |
Malignancy
NO
To evaluate the safty and efficacy of TS-1 and Gemcitabine therapy for elderly patients with unresectable panceatic cancer.
Safety,Efficacy
Exploratory
Pragmatic
Phase II
Median survival time
Safty, disease control rate, 1 year survival rate, progression-free survival
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Gemcitabine 800mg/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.
70 | years-old | <= |
Not applicable |
Male and Female
1) Patients with radiographycally confirmed pancreatic cancer 2) Unresectable pancreatic cancer with or without measurable lesions
3) Who were >/=70 years in age 4) Eastern Cooperative Oncology Group performance status (PS) of 0 or 1
5) No prior surgery, chemotherapy, radiotherapy, or immunotherapy except for biliary drainage or palliative bypass surgery 6) Adequate organ functions, leukocyte count >/=4,000/mm3, neutrophil >/=2,000/mm3, platelet count >/=100,000/mm3, hemoglobin level >/=8.0 g/dl, AST, ALT </=150U/L, total bilirubin </=2.0 mg/dl, creatinine</=1.2 mg/dl, creatinine clearance (Ccr) >/=60 ml/min 7) Estimated life expectancy of at least 2 months 8) Capable of sufficient oral intake 9) With written informed consent
1) Pulmonary fibrosis or interstitial pneumonia 2) Active double cancer, or history of cancer unless it was surgically removed intraepithrial cancer or is considered to be cured with no less that 10 years of recurrence-free
3) Severe complications, such as (1)poorly controlled diabetes melitus and hypertension (2)poorly controlled angina pectoris, heart failure, or myocardial infarction (3)active infection (4)other diseases with inadequate physical condition, such as ileus, bleeding tendency and diarrhea 4) Symptomatic metastasis in central nervous system 5) Severe mental disorders
6) History of drug hypersensitivity
30
1st name | |
Middle name | |
Last name | Mamoru Watanabe |
Tokyo Medical and Dental University
Department of Gastroenterology and Hepatology
1-5-45 Yushima, Bunkyo-ku,Tokyo, Japan 113-8510
1st name | |
Middle name | |
Last name | Shinya Ooka |
Tokyo Medical and Dental University
Department of General Medicine
1-5-45 Yushima, Bunkyo-ku,Tokyo, Japan 113-8510
03-3813-6111
Ochanomizu Gastrointestinal Oncology Group
Ochanomizu Gastrointestinal Oncology Group
Self funding
NO
2010 | Year | 04 | Month | 15 | Day |
Unpublished
Open public recruiting
2010 | Year | 01 | Month | 29 | Day |
2010 | Year | 02 | Month | 01 | Day |
2014 | Year | 01 | Month | 01 | Day |
2010 | Year | 04 | Month | 15 | Day |
2012 | Year | 04 | Month | 05 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004219
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