Phase I study of oral S-1 plus Gemcitabine and concurrent radiotherapy in patients with locally advanced pancreatic cancer

Phase 1

• Conditions: ocally advanced pancreatic cancer

• Registration Number: JPRN-UMIN000001483
• Lead Sponsor: Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-11-06
• Study Completion: 2011-12-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

Not provided

Exclusion Criteria

1)Consciousness disorder 2)NYHA Class of II, III or IV 3)Interstitial pneumonia or pulmonary fibrosis 4)Liver dysfunction of Child-Pugh C 5)Requiring hemodialysis, or serum creatinine level is greater or equal 2.0mg/dL 6)Severe bleeding tendency 7)Poor nutrition (Lymphocyte count is less than 1200, Albumin level is less or equal 2.7g/dL or Pre-albumin level is less or equal 10mg/dL) 8)Acute inflammation 9)Direct invasion of stomach or bowel

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
safety feasibility maximum-tolerated dose recommended dose

Secondary Outcome Measures

Name	Time	Method
response rate at 4 weeks after accomplishment of whole treatment