Patient case: 72-year-old male with Cholangiocarcinoma. Genetic variant: BRCA2. Other conditions: Diabetes.

Clinical trial: Radiation Therapy and Fluorouracil Before Surgery in Treating Patients With Primary or Recurrent Bile Duct Cancer

Summary: 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.

Detailed description: 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.

Eligibility: 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

Relevance to patient case: not relevant