Phase 2 study of S-1 and concurrent breath controlled intensity modulated radiation therapy for locally advanced unresectable pancreatic cancer.

Phase 2

• Conditions: Pancreatic duct adenocarcinoma

• Registration Number: JPRN-UMIN000032642
• Lead Sponsor: Department of Radiology, Sapporo Medical University, School of Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-05-21
• Last Update Posted: 22 January 2024
• Study Completion: 2024-03-31

Recruitment & Eligibility

• Status: Complete: follow-up continuing
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Not provided

Exclusion Criteria

1) Previous history of radiotherapy for pancreatic cancer. 2) Moderate pleural effusion or ascites or cytologically proven pleural or abdominal dissemination. 3) Gastric or duodenal ulcer due to tumor invasion. 4) Active gastric or duodenal ulcer 5) Watery diarrhea 6) Patients requiring the administration of phenytoin, warfarin potassium or flucytosine. 7) Interstitial pneumonia or lung fibrosis. 8) Active infection. 9) Severe complication, such as heart disease, renal disease, and hepatic disease. 10) Patients requiring systemic steroids medication. 11) Psychosis. 12) Drug allergy. 13) Pregnant or lactating women of women of child bearing potential and men who want to get partner pregnant.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Response rate

Secondary Outcome Measures

Name	Time	Method
Completion rate, CA19-9 response rate, Progression free survival, distant metastasis free survival, Overall survival, Rate of adverse event