A Study Of Gemcitabine And Cyberknife Radiation Therapy For Pancreatic Cancer

Study Overview

A Study of Gemcitabine and Cyberknife Radiation Therapy for Pancreatic Cancer

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.

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.

Pancreatic Cancer

RADIATION: Cyberknife radiation and gemcitabine

2009-169

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2010-01-15	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2012-04-23
First Submitted that Met QC Criteria 2010-01-15	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2012-04-24
First Posted (ESTIMATED) 2010-01-18	Results First Posted N/A	Last Verified 2012-04

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Non Randomized

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/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

Participant Group/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

Primary Outcome Measures	Measure Description	Time Frame
To demonstrate that radiation treatments can be reproduced as determined by evaluation of the prescription isodose curves		10 days

Secondary Outcome Measures	Measure Description	Time Frame
Acute and late toxicity as determined by patient self-reporting instruments that assess gastrointestinal side effects		6 months
Quality of life as determined by patient self-reporting instruments		6 months
Acute stomach/duodenal mucosa injury as assessed by upper endoscopy		one month
Late stomach/duodenal mucosa injury as assessed by upper endoscopy		6 months
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		6 months
The feasibility of measuring pancreatic cancer stem cell populations by analysis of fine needle aspirate specimens		6 months

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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

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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Michael J Pishvaian, MD, PhD, Georgetown University

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

PatientS

Caregivers

Clinical Trial Record