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A Phase II Study of Chronomodulated Preoperative Infusional Chemoradiation for Biliary Tract Cancer


Phase 2
18 Years
N/A
Not Enrolling
Both
Extrahepatic Bile Duct Cancer, Liver Cancer

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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 VirginiaCharlottesville, Virginia  22908