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Gemcitabine and Radiation Therapy in Treating Patients With Locally Advanced Upper Gastrointestinal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00544193
Recruitment Status : Completed
First Posted : October 16, 2007
Last Update Posted : June 8, 2015
National Cancer Institute (NCI)
Information provided by (Responsible Party):
City of Hope Medical Center

Brief Summary:

RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving chemotherapy together with radiation therapy may kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of gemcitabine when given together with radiation therapy in treating patients with locally advanced upper gastrointestinal cancer.

Condition or disease Intervention/treatment Phase
Extrahepatic Bile Duct Cancer Gallbladder Cancer Gastric Cancer Pancreatic Cancer Small Intestine Cancer Drug: gemcitabine hydrochloride Genetic: polymerase chain reaction Other: immunohistochemistry staining method Procedure: conventional surgery Radiation: intraoperative radiation therapy Radiation: radiation therapy Phase 1

Detailed Description:


  • 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Primary Purpose: Treatment
Official Title: Pilot Study of Gemcitabine and IORT/EBRT in Locally Advanced Upper Gastrointestinal Malignancies
Study Start Date : December 1997
Actual Primary Completion Date : August 2012
Actual Study Completion Date : August 2012

Primary Outcome Measures :
  1. Feasibility
  2. Tolerance
  3. Measurement of biochemical parameters in tumors that may correlate with the effectiveness of therapy

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00544193

Sponsors and Collaborators
City of Hope Medical Center
National Cancer Institute (NCI)
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Study Chair: Stephen I. Shibata, MD City of Hope Comprehensive Cancer Center
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Responsible Party: City of Hope Medical Center Identifier: NCT00544193    
Other Study ID Numbers: 97087
P30CA033572 ( U.S. NIH Grant/Contract )
First Posted: October 16, 2007    Key Record Dates
Last Update Posted: June 8, 2015
Last Verified: June 2015
Keywords provided by City of Hope Medical Center:
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
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Stomach Neoplasms
Gallbladder Neoplasms
Bile Duct Neoplasms
Intestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gastrointestinal Neoplasms
Gastrointestinal Diseases
Stomach Diseases
Biliary Tract Neoplasms
Biliary Tract Diseases
Gallbladder Diseases
Bile Duct Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Intestinal Diseases
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents