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Radiation Therapy and Fluorouracil Before Surgery in Treating Patients With Primary or Recurrent Bile Duct Cancer
This study is ongoing, but not recruiting participants.
Sponsored by: European Organization for Research and Treatment of Cancer
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00030511
  Purpose

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.


Condition Intervention Phase
Extrahepatic Bile Duct Cancer
Liver Cancer
Drug: fluorouracil
Procedure: conventional surgery
Procedure: radiation therapy
Phase II

MedlinePlus related topics: Cancer Liver Cancer
Drug Information available for: Fluorouracil
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment
Official Title: A Phase II Study of Chronomodulated Preoperative Infusional Chemoradiation for Biliary Tract Cancer

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: October 2001
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00030511

Locations
United States, Virginia
Cancer Center at the University of Virginia
Charlottesville, Virginia, United States, 22908
Belgium
Hopital de Jolimont
Haine Saint Paul, Belgium, 7100
Les Cliniques Saint-Joseph ASBL
Liege, Belgium, B 4000
France
Hopital Paul Brousse
Villejuif, France, 94804
Hopital Cochin
Paris, France, 75674
Centre Hospital Regional Universitaire de Limoges
Limoges, France, 87042
Sponsors and Collaborators
European Organization for Research and Treatment of Cancer
Investigators
Investigator: Tyvin A. Rich, MD University of Virginia
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Study ID Numbers: CDR0000069171, EORTC-05991
Study First Received: February 14, 2002
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00030511  
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
localized resectable adult primary liver cancer
recurrent adult primary liver cancer
localized extrahepatic bile duct cancer
recurrent extrahepatic bile duct cancer

Study placed in the following topic categories:
Bile duct cancer, extrahepatic
Liver Diseases
Digestive System Neoplasms
Biliary Tract Neoplasms
Liver neoplasms
Biliary tract cancer
Recurrence
Liver Neoplasms
Digestive System Diseases
Bile Duct Diseases
Fluorouracil
Biliary Tract Diseases
Gastrointestinal Neoplasms
Bile Duct Neoplasms

Additional relevant MeSH terms:
Antimetabolites
Neoplasms
Antimetabolites, Antineoplastic
Neoplasms by Site
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Physiological Effects of Drugs
Immunosuppressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009