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A Pilot Study of Full Dose Gemcitabine and Hypofractionated Stereotactic Radiosurgery in the Treatment of Unresectable Pancreatic Cancer


Phase 1
18 Years
N/A
Not Enrolling
Both
Pancreatic Cancer

Thank you

Trial Information

A Pilot Study of Full Dose Gemcitabine and Hypofractionated Stereotactic Radiosurgery in the Treatment of Unresectable 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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To demonstrate that radiation treatments can be reproduced as determined by evaluation of the prescription isodose curves

Outcome Time Frame:

10 days

Safety Issue:

Yes

Principal Investigator

Michael J Pishvaian, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Georgetown University

Authority:

United States: Institutional Review Board

Study ID:

2009-169

NCT ID:

NCT01051284

Start Date:

November 2009

Completion Date:

March 2012

Related Keywords:

  • Pancreatic Cancer
  • Pancreas
  • Newly diagnosed
  • Cyberknife
  • Gemcitabine
  • Pancreatic Neoplasms

Name

Location

Georgetown University Medical CenterWashington, District of Columbia  20007