Back to resultsA Study of Gemcitabine and Cyberknife Radiation Therapy for Pancreatic Cancer
Primary Purpose
Pancreatic Cancer
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Cyberknife radiation and gemcitabine
Sponsored by
About this trial
This is an interventional treatment trial for Pancreatic Cancer focused on measuring Pancreas, Newly diagnosed, Cyberknife, Gemcitabine
Eligibility Criteria
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.
Sites / Locations
- Georgetown University Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Cyberknofe and Gemcitabine
Arm Description
Cyberknife radiation and 6 cycles Gemcitabine
Outcomes
Primary Outcome Measures
To demonstrate that radiation treatments can be reproduced as determined by evaluation of the prescription isodose curves
Secondary Outcome Measures
Acute and late toxicity as determined by patient self-reporting instruments that assess gastrointestinal side effects
Quality of life as determined by patient self-reporting instruments
Acute stomach/duodenal mucosa injury as assessed by upper endoscopy
Late stomach/duodenal mucosa injury as assessed by upper endoscopy
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
The feasibility of measuring pancreatic cancer stem cell populations by analysis of fine needle aspirate specimens
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01051284
Brief Title
A Study of Gemcitabine and Cyberknife Radiation Therapy for Pancreatic Cancer
Official Title
A Pilot Study of Full Dose Gemcitabine and Hypofractionated Stereotactic Radiosurgery in the Treatment of Unresectable Pancreatic Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
February 2011 (Actual)
Study Completion Date
March 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Georgetown University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer
Keywords
Pancreas, Newly diagnosed, Cyberknife, Gemcitabine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cyberknofe and Gemcitabine
Arm Type
Experimental
Arm Description
Cyberknife radiation and 6 cycles Gemcitabine
Intervention Type
Radiation
Intervention Name(s)
Cyberknife radiation and gemcitabine
Other Intervention Name(s)
Gemcitabine, Gemzar
Intervention Description
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
Primary Outcome Measure Information:
Title
To demonstrate that radiation treatments can be reproduced as determined by evaluation of the prescription isodose curves
Time Frame
10 days
Secondary Outcome Measure Information:
Title
Acute and late toxicity as determined by patient self-reporting instruments that assess gastrointestinal side effects
Time Frame
6 months
Title
Quality of life as determined by patient self-reporting instruments
Time Frame
6 months
Title
Acute stomach/duodenal mucosa injury as assessed by upper endoscopy
Time Frame
one month
Title
Late stomach/duodenal mucosa injury as assessed by upper endoscopy
Time Frame
6 months
Title
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
Title
The feasibility of measuring pancreatic cancer stem cell populations by analysis of fine needle aspirate specimens
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael J Pishvaian, MD, PhD
Organizational Affiliation
Georgetown University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Georgetown University Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Study of Gemcitabine and Cyberknife Radiation Therapy for Pancreatic Cancer
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