Liver Cancer Clinical Trial
Official title:
A Phase II Study of Chronomodulated Preoperative Infusional Chemoradiation for Biliary Tract Cancer
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in
chemotherapy use different ways to stop tumor cells from dividing so they stop growing or
die. Combining radiation therapy with chemotherapy before surgery may shrink the tumor so
that it can be removed during surgery.
PURPOSE: Phase II trial to study the effectiveness of combining radiation therapy with
fluorouracil before surgery in treating patients who have primary or recurrent bile duct
cancer.
OBJECTIVES:
- Determine the pathologic response rate in patients with primary or recurrent biliary
duct carcinoma treated with neoadjuvant radiotherapy and fluorouracil followed by
surgical resection.
- 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
disease progression.
PROJECTED ACCRUAL: A total of 20-47 patients will be accrued for this study within 2.5
years.
;
Primary Purpose: Treatment
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