Gemcitabine/Capecitabine Followed by SBRT in Pancreatic Adenocarcinoma

PHASE2CompletedINTERVENTIONAL
Enrollment

35

Participants

Timeline

Start Date

July 25, 2011

Primary Completion Date

March 13, 2016

Study Completion Date

October 31, 2018

Conditions
Pancreatic Cancer
Interventions
DRUG

Gemcitabine

"Gemcitabine will be administered for 2 weekly doses every 3 weeks commencing 12 weeks prior to stereotactic radiosurgery as follows:~Gemcitabine 1,000 mg/m2 IV over 30 minutes on Day 1, and 8 of 21- day cycle. This will be done for up to 4 cycles."

DRUG

Capecitabine

"Capecitabine will be taken orally twice daily on days 1-14 every 3 weeks for 4 cycles (12 weeks) prior to stereotactic radiosurgery as follows:~Capecitabine 650 mg/m2 twice daily for days 1-14 every 3 weeks for up to 4 cycles."

RADIATION

Stereotactic Body Radiation Therapy (SBRT)

"Fractionated SBRT will be delivered to patients that have stable disease, partial response, or complete response after chemo in the following manner:~12 Gy x 3 fractions (36 Gy total) This will be given every other day."

Trial Locations (1)

15232

UPMC Cancer Centers, Pittsburgh

All Listed Sponsors
lead

David A. Clump, MD, PhD

OTHER

NCT01360593 - Gemcitabine/Capecitabine Followed by SBRT in Pancreatic Adenocarcinoma | Biotech Hunter | Biotech Hunter