Adjuvant Gemcitabine and Cisplatin Followed by Chemoradiation for Resected Pancreatic Cancer

PHASE2CompletedINTERVENTIONAL
Enrollment

70

Participants

Timeline

Start Date

December 31, 2004

Primary Completion Date

June 30, 2011

Study Completion Date

June 30, 2011

Conditions
Pancreatic Cancer
Interventions
DRUG

gemcitabine and cisplatin

The study consists of three phases; Induction chemotherapy phase:Starting 4\~8 weeks after R0 resection of pancreatic cancer. Gemcitabine: 1200mg/㎡ (Day 1, 8), cisplatin 60mg/㎡ (Day 1) every 3 weeks for 2 cycles. Chemoradiotherapy phase: Starting 1-2 weeks after completion of induction chemotherapy (within 5 weeks after D1 of 2nd cycle of induction chemotherapy), no later than 16 weeks after operation. Gemcitabine 300mg/㎡ weekly for 5 weeks throughout RT period. Radiotherapy: 50.4Gy at 1.8Gy/Fx, for 28 Fx (Field reduction at 45Gy) for 5.5 pweeks. Maintenance chemotherapy phase: Within 4 weeks after completion of chemoradiotheray, no later than 6 weeks after completion of chemoradiotherapy Gemcitabine: 1200mg/㎡ (Day 1, 8) every 3 weeks, for 4 cycles

Trial Locations (2)

Unknown

Seoul National University Bundang Hospital, Seongnam

Seoul National University Hospital, Seoul

All Listed Sponsors
lead

Seoul National University Hospital

OTHER

NCT01396681 - Adjuvant Gemcitabine and Cisplatin Followed by Chemoradiation for Resected Pancreatic Cancer | Biotech Hunter | Biotech Hunter