A Study of Gemcitabine and Cyberknife Radiation Therapy for Pancreatic 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: NCT01051284
Recruitment Status : Completed
First Posted : January 18, 2010
Last Update Posted : April 24, 2012
Information provided by (Responsible Party):
Michael J Pishvaian, Georgetown University

Brief Summary:

People with pancreatic cancer that cannot be cured by surgery are being asked to participate in this study.

The purpose of this study is to test the ability of the radiation oncologists to administer Cyberknife therapy along with Gemcitabine chemotherapy for patients with pancreatic cancer. Radiation and Gemcitabine are both effective at killing cancer cells but they generally cannot be given at the same time. Cyberknife therapy is highly focused radiation that is being used extensively at Georgetown University and around the United States to treat a number of cancers. It is believed that because Cyberknife is so highly focused it can be given safely with regular doses of chemotherapy to attack cancer cells in two ways at the same time.

This research is being done because it is not known if using Cyberknife with chemotherapy will be a safe way to treat pancreatic cancer.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Radiation: Cyberknife radiation and gemcitabine Phase 1

Detailed Description:
This is a single arm, open-label pilot study of Cyberknife plus Gemcitabine in 10 patients with locally advanced pancreatic cancer who have not received prior local or systemic therapy for their pancreatic cancer.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study of Full Dose Gemcitabine and Hypofractionated Stereotactic Radiosurgery in the Treatment of Unresectable Pancreatic Cancer
Study Start Date : November 2009
Actual Primary Completion Date : February 2011
Actual Study Completion Date : March 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Cyberknofe and Gemcitabine
Cyberknife radiation and 6 cycles Gemcitabine
Radiation: Cyberknife radiation and gemcitabine
25 Gray of radiation will be given in 5 fractions using the Cyberknife Gemcitabine 1000 mg/m2 intravenously will be given once a week on days 1, 8, and 15 of every 28-day cycle for 6 cycles
Other Names:
  • Gemcitabine
  • Gemzar

Primary Outcome Measures :
  1. To demonstrate that radiation treatments can be reproduced as determined by evaluation of the prescription isodose curves [ Time Frame: 10 days ]

Secondary Outcome Measures :
  1. Acute and late toxicity as determined by patient self-reporting instruments that assess gastrointestinal side effects [ Time Frame: 6 months ]
  2. Quality of life as determined by patient self-reporting instruments [ Time Frame: 6 months ]
  3. Acute stomach/duodenal mucosa injury as assessed by upper endoscopy [ Time Frame: one month ]
  4. Late stomach/duodenal mucosa injury as assessed by upper endoscopy [ Time Frame: 6 months ]
  5. Feasibility of integrating metabolomic analysis into the evaluation of patients with unresectable pancreatic cancer undergoing chemotherapy and radiation therapy measured by the ability to collect tumor specimens [ Time Frame: 6 months ]
  6. The feasibility of measuring pancreatic cancer stem cell populations by analysis of fine needle aspirate specimens [ Time Frame: 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Histologically proven unresectable, non-metastatic pancreatic adenocarcinoma with measurable or evaluable disease and without involvement of the duodenum
  • Performance Status 0-2
  • No prior anticancer therapy for pancreatic adenocarcinoma
  • No prior anticancer therapy of any kind within the last 5 years
  • Adequate hepatic, bone marrow, and renal function
  • Life expectance of > 12 weeks
  • Women of childbearing potential must have a negative serum pregnancy test

Exclusion Criteria:

  • Duodenal involvement of pancreatic cancer
  • Metastatic cancer
  • Active severe infection, or known chronic infection with HIV, hepatitis B virus, or hepatitis C virus
  • Cardiovascular disease including unstable angina, therapy for life-threatening ventricular arrhythmia, myocardial infarction, stroke, or congestive heart failure within the last 6 months
  • Life-threatening visceral disease or other severe concurrent disease
  • Pregnant or breastfeeding
  • Anticipated patient survival under 3 months
  • Another active malignancy within the past 5 years except for cervical cancer in situ, in situ carcinoma of the bladder or non-melanoma carcinoma of the skin.

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): NCT01051284

United States, District of Columbia
Georgetown University Medical Center
Washington, District of Columbia, United States, 20007
Sponsors and Collaborators
Georgetown University
Principal Investigator: Michael J Pishvaian, MD, PhD Georgetown University

Responsible Party: Michael J Pishvaian, Assistant Professor, Georgetown University Identifier: NCT01051284     History of Changes
Other Study ID Numbers: 2009-169
First Posted: January 18, 2010    Key Record Dates
Last Update Posted: April 24, 2012
Last Verified: April 2012

Keywords provided by Michael J Pishvaian, Georgetown University:
Newly diagnosed

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs