A phase 2 study of combination neoadjuvant chemotherapy with gemcitabine S-1 and leucovorin in patients with borderline and locally advanced pancreatic cancer
- Conditions
- Borderline and Locally advanced pancreatic cancer
- Registration Number
- JPRN-UMIN000012480
- Lead Sponsor
- The University of Tokyo Hospital
- Brief Summary
Twenty-four patients with PC (21 BR and 3 LA) were enrolled. Response rate and disease control rate of NAC were 17.4 and 87.0%. Grade 3 and 4 toxicities involved neutropenia (34.8%), anorexia (17.4%), and mucositis (17.4%). Serum CA19-9 level decreased by 52.2%. Resection rate was 60.9% after the median of 4 cycles and R0 resection rate was 76.5% in patients undergoing laparotomy. NAC-GSL is a feasible treatment option for BR and LAPC.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 24
Not provided
1) Patients with systolic blood pressure < 100mmHg 2) Patients with an active concomitant infection 3) Patients with digestive ulcer or gastrointestinal bleeding, severe heart or renal disease 4) Patients with an active pulmonary fibrosis or interstitial pneumonia 5) Patients with severe diarrhea 6) Pregnant, lactating female and patients of reproductive potential who did not use effective contraception 7) Patients with uncontrollable massive pleural effusion or massive ascites 8) Patients with an active concomitant malignancy 9) Inappropriate patients for entry on this study in the judgement of the investigator
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method R0 resection rate
- Secondary Outcome Measures
Name Time Method Resection rate, Progression free survival, Overall survival, Response rate, Disease control rate, Adverse events, Intra-operative complication, Post-operative complication, Operative time, Postoperative length of stay