A Study of Gemcitabine and Cyberknife Radiation Therapy for Pancreatic Cancer

NCT ID: NCT01051284

Last Updated: 2012-04-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-11-30
• Study Completion Date: 2012-03-31

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.

Conditions

Pancreatic Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cyberknofe and Gemcitabine

Cyberknife radiation and 6 cycles Gemcitabine

Group Type: EXPERIMENTAL

Cyberknife radiation and gemcitabine

Intervention Type: RADIATION

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

Interventions

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

Intervention Type: RADIATION

Other Intervention Names

Gemcitabine; Gemzar

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Georgetown University

OTHER

Sponsor Role: lead

Responsible Party

Michael J Pishvaian

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michael J Pishvaian, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Georgetown University

Locations

Georgetown University Medical Center

Washington D.C., District of Columbia, United States

Countries

United States

Other Identifiers

2009-169

Identifier Type: -

Identifier Source: org_study_id