A Study of Gemcitabine and Cyberknife Radiation Therapy for Pancreatic Cancer

Launched by GEORGETOWN UNIVERSITY · Jan 15, 2010

Keywords

ClinConnect Summary

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.

Gender

ALL

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.