Multicenter Phase II study of TS-1 and gemcitabine combination therapy for elderly patients with unresectable 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.

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000003496

Enrollment

Registered

2010-04-15

Start date

2010-02-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Elderly patients with unresectable pancreatic cancer

Interventions

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.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
Median survival time	—

Secondary

Measure	Time frame
Safty, disease control rate, 1 year survival rate, progression-free survival	—

Countries

Japan

Contacts

Public ContactShinya Ooka

Tokyo Medical and Dental University Department of General Medicine

03-3813-6111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026