Gemcitabine/TS-1 combination chemoradiotherapy for unresectable locally advanced pancreatic cancer(Phase I study)

Gemcitabine/TS-1 combination chemoradiotherapy for unresectable locally advanced pancreatic cancer(Phase I study) - Phase I study of CRT+GS for PC

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000005042

Enrollment

Registered

2011-02-07

Start date

2006-12-01

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

Unresectable locally advanced pancreatic cancer

Interventions

Gemcitabine 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

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Histologically or cytologically confirmed advanced pancreatic cancer 2.Locally advanced pancreatic cancer is defined as the presence of a surgically unresectable tumor(involving the celiac axis or the superior mesenteric artery) 3.Performance Status:0-1(ECOG) 4.Patients of age =>20 and 75> 5.WBC>=3,500/mm3,12,000/mm3, neutrophils >=1,500/mm3, platelets=100,000/mm3, hemoglobin >=9.5 g/dl, GOT </=2.0 X ULN, GPT </=2.0 X ULN, AL-P </=2.0 X ULN, total bilirubin <=1.5mg/dl, serum creatinine <=1.2mg/dl, creatinine clearance>=50 ml/min 6.Life expectancy more than 3 months. 7.Written informed consent.

Exclusion criteria

Exclusion criteria: 1.Active infection 2.Lung fibrosis or intestinal pneumoni detectable on chest X-ray and CT 3.Severe complication (heart disease, cirrhosis, diabetes) 4.Myocardial infarction within 3 months 5.Active synchronous or metachronous malignancy 6.Pregnant or lactation women, or women with known or suspected pregnancy 7.Symptomatic brain metastasis 8.history of severe drug allergy 9.Patients who are judged inappropriate for the entry into the study by the investigater

Design outcomes

Primary

Measure	Time frame
Safety	—

Secondary

Measure	Time frame
Efficacy, Median survival time (MST), Palliative efficacy	—

Countries

Japan

Contacts

Public ContactTatsuya Ioka

Osaka Medical Center for Cancer and Cardiovascular Diseases Division of Hepatobiliary and Pancreatic Oncology

ioka_ta@hotmail.com06-6945-1181

Outcome results

None listed

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