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Pilot Study of Gemcitabine and IORT/EBRT in Locally Advanced Upper Gastrointestinal Malignancies

Phase 1
18 Years
70 Years
Not Enrolling
Extrahepatic Bile Duct Cancer, Gallbladder Cancer, Gastric Cancer, Pancreatic Cancer, Small Intestine Cancer

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Trial Information

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
external-beam radiotherapy.

- To measure biochemical parameters in tumors that may correlate with the effectiveness
of therapy.

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
reaction (PCR).

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.

Inclusion Criteria


- Diagnosis of any of the following upper gastrointestinal malignancies:

- Localized pancreatic adenocarcinoma

- Stage I, II, or III disease

- Parapancreatic node involvement and locally recurrent disease allowed

- Locally advanced biliary, gallbladder, or ampullary adenocarcinoma

- Stage II, III, or locally recurrent disease

- Histologically confirmed locally advanced gastric adenocarcinoma

- T3, T4, or node positive OR locally recurrent disease

- Histologically confirmed locally advanced duodenal cancer

- Stage II or III disease

- Locally advanced, but unresectable cancers may be included on protocol if appropriate
for intraoperative radiotherapy (IORT)

- Other histologies may be considered for this protocol except for lymphoma, sarcoma,
or neuroendocrine tumors

- Patients with evidence of metastatic disease are eligible if there is significant
local disease warranting surgery and IORT


- Karnofsky performance status > 60%

- Life expectancy > 4 months

- Absolute neutrophil count > 1,500/mm^3

- Platelet count > 100,000/mm^3

- Serum creatinine < 2.0 mg/dL

- ALT < 3 x normal

- Bilirubin < 2 x normal

- Must be able to give voluntary informed consent

- No severe intercurrent illness that would make the patient inappropriate for
laparotomy or otherwise inappropriate for treatment on protocol

- Prior history of malignancy allowed


- More than 4 weeks since prior chemotherapy (6 weeks for mitomycin C)

- Prior gemcitabine hydrochloride allowed

Type of Study:


Study Design:

Primary Purpose: Treatment

Outcome Measure:


Safety Issue:


Principal Investigator

Stephen I. Shibata, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Beckman Research Institute


United States: Federal Government

Study ID:




Start Date:

December 1997

Completion Date:

Related Keywords:

  • Extrahepatic Bile Duct Cancer
  • Gallbladder Cancer
  • Gastric Cancer
  • Pancreatic Cancer
  • Small Intestine Cancer
  • adenocarcinoma of the extrahepatic bile duct
  • adenocarcinoma of the gallbladder
  • adenocarcinoma of the pancreas
  • adenocarcinoma of the stomach
  • stage I pancreatic cancer
  • stage II pancreatic cancer
  • stage III pancreatic cancer
  • localized extrahepatic bile duct cancer
  • recurrent extrahepatic bile duct cancer
  • unresectable extrahepatic bile duct cancer
  • localized gallbladder cancer
  • recurrent gallbladder cancer
  • unresectable gallbladder cancer
  • recurrent gastric cancer
  • stage II gastric cancer
  • stage III gastric cancer
  • stage IV gastric cancer
  • stage I gastric cancer
  • recurrent pancreatic cancer
  • small intestine adenocarcinoma
  • stage IV pancreatic cancer
  • Stomach Neoplasms
  • Pancreatic Neoplasms
  • Duodenal Neoplasms
  • Ileal Neoplasms
  • Jejunal Neoplasms
  • Gallbladder Neoplasms
  • Bile Duct Neoplasms
  • Intestinal Neoplasms
  • Gastrointestinal Neoplasms