A Phase II Study of Chronomodulated Preoperative Infusional Chemoradiation for Biliary Tract Cancer
- Determine the pathologic response rate in patients with primary or recurrent biliary
duct carcinoma treated with neoadjuvant radiotherapy and fluorouracil followed by
- Determine the tumor response, morbidity, failure patterns (locoregional vs distant),
and survival in patients treated with this regimen.
- Determine the toxic effects of this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients undergo radiotherapy once daily five days a week for 5.5 weeks. Patients receive
fluorouracil IV over 12 hours each day radiotherapy is administered. Four to six weeks after
completion of chemoradiotherapy, patients undergo surgical resection. Patients with residual
disease after resection may undergo boost radiotherapy.
Patients are followed every 12 weeks until disease progression and then every 16 weeks after
PROJECTED ACCRUAL: A total of 20-47 patients will be accrued for this study within 2.5
Primary Purpose: Treatment
Tyvin A. Rich, MD
University of Virginia
United States: Federal Government
|Cancer Center at the University of Virginia||Charlottesville, Virginia 22908|