Phase II Trial Of Adjuvant 2'2'-Difluoro-2'-Deoxycytidine (Gemcitabine) And External Beam Radiation For The Treatment Of Resectable Pancreatic Cancer
OBJECTIVES:
- Determine the time to disease progression, local control, and survival of patients with
previously resected pancreatic cancer treated with adjuvant gemcitabine and
radiotherapy.
OUTLINE: This is a multicenter study.
Patients receive gemcitabine IV over 30-60 minutes on days 1, 4, 8, 11, 15, 18, 22, 25, 29,
and 32 and undergo radiotherapy on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-38 in the
absence of disease progression or unacceptable toxicity.
Beginning at least 4 weeks after chemoradiotherapy, patients without disease progression and
with less than 10% weight loss during study receive additional gemcitabine IV over 30
minutes on days 1, 8, and 15. Treatment repeats every 28 days for a total of 2 courses.
Patients are followed every 8 weeks for 6 months and then every 3 months for up to 2 years.
PROJECTED ACCRUAL: A total of 72 patients will be accrued for this study within 2.2 or 3.4
years.
Interventional
Primary Purpose: Treatment
Arthur William Blackstock, MD
Study Chair
Comprehensive Cancer Center of Wake Forest University
United States: Federal Government
CDR0000068452
NCT00010166
December 2000
Name | Location |
---|---|
Comprehensive Cancer Center at Wake Forest University | Winston-Salem, North Carolina 27157-1082 |