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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00030511
Recruitment Status : Terminated (low accrual)
First Posted : January 27, 2003
Last Update Posted : July 16, 2012
Sponsor:
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC

Brief 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.


Condition or disease Intervention/treatment Phase
Extrahepatic Bile Duct Cancer Liver Cancer Drug: fluorouracil Procedure: conventional surgery Radiation: radiation therapy Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Official Title: A Phase II Study of Chronomodulated Preoperative Infusional Chemoradiation for Biliary Tract Cancer
Study Start Date : October 2001
Actual Primary Completion Date : July 2003






Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00030511


Locations
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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 Organisation for Research and Treatment of Cancer - EORTC
Investigators
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Study Chair: Tyvin A. Rich, MD University of Virginia

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Responsible Party: European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier: NCT00030511    
Other Study ID Numbers: EORTC-05991
EORTC-05991
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: July 16, 2012
Last Verified: July 2012
Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC:
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:
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Liver Neoplasms
Bile Duct Neoplasms
Cholangiocarcinoma
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Liver Diseases
Biliary Tract Neoplasms
Bile Duct Diseases
Biliary Tract Diseases
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Fluorouracil
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs