A Phase II Study of Chronomodulated Preoperative Infusional Chemoradiation for Biliary Tract Cancer
18 Years
N/A
Both
Extrahepatic Bile Duct Cancer, Liver Cancer
Trial Information
A Phase II Study of Chronomodulated Preoperative Infusional Chemoradiation for Biliary Tract 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.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed primary or recurrent biliary duct carcinoma from the
proximal, middle, or distal bile ducts
- Measurable or evaluable disease that is considered resectable
- No distant metastases
- No non-contiguous liver metastases
- Resectable extension into adjacent liver allowed
- No metastasis to peritoneal cavity
- No Bismuth type 4 lesion or metastasis to celiac axis or para-aortic lymph nodes
- No tumor encasement of portal vein or hepatic artery
- No gross ascites
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- ECOG 0-1
Life expectancy:
- Not specified
Hematopoietic:
- Absolute neutrophil count greater than 1,500/mm^3
- Platelet count greater than 100,000/mm^3
Hepatic:
- No cirrhosis
- No active cholangitis
- No fever or signs of infection in biliary drainage system
- Measurement of C-reactive protein optimal
- Bilirubin less than 3 mg/dL
Renal:
- Creatinine less than 1.5 mg/dL OR
- Creatinine clearance greater than 60 mL/min
Other:
- Not pregnant or nursing
- Fertile patients must use effective barrier contraception during and for 3 months
after study
- No weight loss greater than 20% ideal body weight
- No active duodenal or gastric ulcers
- No other prior or concurrent primary malignancy except adequately treated carcinoma
in situ of the cervix or basal cell carcinoma
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- At least 4 weeks since prior chemotherapy
Endocrine therapy:
- Not specified
Radiotherapy:
- No prior radiotherapy
Surgery:
- See Disease Characteristics
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Tyvin A. Rich, MD
Investigator Role:
Study Chair
Investigator Affiliation:
University of Virginia
Authority:
United States: Federal Government
Study ID:
EORTC-05991
NCT ID:
NCT00030511
Start Date:
October 2001
Completion Date:
Related Keywords:
- Extrahepatic Bile Duct Cancer
- Liver Cancer
- localized resectable adult primary liver cancer
- recurrent adult primary liver cancer
- localized extrahepatic bile duct cancer
- recurrent extrahepatic bile duct cancer
- Liver Neoplasms
- Bile Duct Neoplasms
- Biliary Tract Neoplasms
Name | Location |
|---|---|
| Cancer Center at the University of Virginia | Charlottesville, Virginia 22908 |
