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Radiation Therapy and Fluorouracil Before Surgery in Treating Patients With Primary or Recurrent Bile Duct Cancer
The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2003 by National Cancer Institute (NCI).   Recruitment status was  Active, not recruiting

First Received on February 14, 2002.   Last Updated on February 6, 2009   History of Changes
Sponsor: European Organization for Research and Treatment of Cancer - EORTC
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
Radiation: radiation therapy
Phase II

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: A Phase II Study of Chronomodulated Preoperative Infusional Chemoradiation for Biliary Tract Cancer

Resource links provided by NLM:


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
Centre Hospital Regional Universitaire de Limoges
Limoges, France, 87042
Hopital Cochin
Paris, France, 75674
Hopital Paul Brousse
Villejuif, France, 94804
Sponsors and Collaborators
European Organization for Research and Treatment of Cancer - EORTC
Investigators
Investigator: Tyvin A. Rich, MD University of Virginia
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00030511     History of Changes
Other Study ID Numbers: CDR0000069171, EORTC-05991
Study First Received: February 14, 2002
Last Updated: February 6, 2009
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

Additional relevant MeSH terms:
Liver Neoplasms
Bile Duct Neoplasms
Biliary Tract Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Liver Diseases
Bile Duct Diseases
Biliary Tract Diseases
Fluorouracil
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 12, 2012