Pilot Study of Gemcitabine and IORT/EBRT in Locally Advanced Upper Gastrointestinal Malignancies
- To determine the feasibility of combining preoperative or intraoperative gemcitabine
hydrochloride with intraoperative radiotherapy.
- To determine the tolerance of gemcitabine hydrochloride given concurrently with
- To measure biochemical parameters in tumors that may correlate with the effectiveness
OUTLINE: Patients receive gemcitabine hydrochloride IV 12-18 hours prior to planned surgery.
All patients then undergo an exploratory laparotomy that may include tumor debulking,
Whipple-type resection (pancreaticoduodenectomy), total pancreatectomy, gastrojejunostomy,
total or partial gastrectomy, or cholecystectomy and en bloc resection depending on the
extent of the disease. Patients with no metastatic disease beyond regional lymph nodes also
undergo intraoperative radiotherapy.
Beginning 2-6 weeks after surgery, patients undergo external-beam radiotherapy (EBRT) once a
day 5 days a week for up to 7 weeks. Patients also receive escalating doses of gemcitabine
hydrochloride IV at the beginning of each week of EBRT.
Patients undergo tissue sample collection periodically for correlative studies. Samples are
analyzed for thymidylate synthase (TS), ribonucleotide reductase (RR),
excision-repair-cross-complementing (ERCC)-1 protein, deoxycytidine kinase mRNA. Biopsy
tissues are also analyzed for gemcitabine triphosphate, dATP, and dCTP content. p53 status
is assessed via immunohistochemistry and mRNA levels via quantitative polymerase chain
After completion of study treatment, patients are followed every 3 months for 2 years, every
6 months for 2 years, and then once a year thereafter.
Primary Purpose: Treatment
Stephen I. Shibata, MD
Beckman Research Institute
United States: Federal Government