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Phase II Multi-Institutional Study to Evaluate the Efficacy of Gemcitabine and Fractionated Stereotactic Radiotherapy for Unresectable Pancreatic Adenocarcinoma

This multi-institutional trial aims to evaluate the potential benefit and side effects of adding fractionated stereotactic body radiotherapy/surgery (SBRT) before and after chemotherapy with gemcitabine for locally advanced pancreatic cancer.

Stanford is not currently accepting new patients for this trial. You may want to check to see if other locations are recruiting.



  • device : CyberKnife based stereotactic radiotherapy
  • drug : Gemcitabine
  • drug : Fludeoxyglucose (18F)

Phase: Phase 2


Ages Eligible For Study:

18 Years - N/A

Inclusion Criteria

3.1.1 Histologically confirmed adenocarcinoma of the pancreas. 3.1.2 Unresectable disease as determined by a pancreatic cancer surgeon and assessment at a GI oncology tumor board (JHU, SU, or MSKCC). 3.1.3 Up to 3 weeks of gemcitabine chemotherapy is allowed prior to SBRT. 3.1.4 Pancreatic tumors must be less than 7.5 cm in greatest axial dimension (or <1000 cc in volume) at the time of treatment planning. 3.1.5 No prior upper abdominal or liver radiation therapy. 3.1.6 No chemotherapy within 2 weeks of radiotherapy, or chemotherapy within parameters set by Investigator for each institution. 3.1.7 Age >=18 years. 3.1.8 No infections requiring systemic antibiotic treatment. 3.1.9 Karnofsky >= 70% (see Appendix III). 3.1.10 Patients must have acceptable organ and marrow function as defined below (within 1 month prior to radiotherapy): - leukocytes: >=3,000/uL - absolute neutrophil count: >=1,500uL - platelets: >=100,000/uL - total bilirubin: within 1.5X normal institutional limits - AST(SGOT)/ALT(SGPT): <=2.5 X institutional upper limit of normal - creatinine: within normal institutional limits OR - creatinine clearance: >=60 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal 3.1.11 The effects of radiation on the developing human fetus at recommended therapeutic doses can result in death of the fetus. If a woman is of child-bearing potential, a negative urine or serum pregnancy test must be demonstrated prior to treatment. Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) for the duration of study participation and for up to 4 weeks following the study. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. 3.1.12 Ability to understand and the willingness to sign a written informed consent document. 3.1.13 Life expectancy > 6 months

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Contact information

Primary Contact:

Laurie Ann Columbo 650-736-0792

Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305

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