NCT00030511

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.

Trial Health

40
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
3 countries

6 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2001

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 14, 2002

Completed
12 months until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2003

Completed
Last Updated

July 16, 2012

Status Verified

July 1, 2012

Enrollment Period

1.7 years

First QC Date

February 14, 2002

Last Update Submit

July 13, 2012

Conditions

Extrahepatic Bile Duct CancerLiver Cancer

Keywords

localized resectable adult primary liver cancerrecurrent adult primary liver cancerlocalized extrahepatic bile duct cancerrecurrent extrahepatic bile duct cancer

Interventions

fluorouracilDRUG
conventional surgeryPROCEDURE
radiation therapyRADIATION

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (6)

Cancer Center at the University of Virginia

Charlottesville, Virginia, 22908, United States

Location

Hopital de Jolimont

Haine-Saint-Paul, 7100, Belgium

Location

Les Cliniques Saint-Joseph ASBL

Liège, B 4000, Belgium

Location

Centre Hospital Regional Universitaire de Limoges

Limoges, 87042, France

Location

Hopital Cochin

Paris, 75674, France

Location

Hopital Paul Brousse

Villejuif, 94804, France

Location

MeSH Terms

Conditions

Bile Duct NeoplasmsLiver NeoplasmsCarcinoma, Hepatocellular

Interventions

FluorouracilRadiotherapy

Condition Hierarchy (Ancestors)

Biliary Tract NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsBile Duct DiseasesBiliary Tract DiseasesDigestive System DiseasesLiver DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

UracilPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsTherapeutics

Study Officials

  • Tyvin A. Rich, MD

    University of Virginia

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 14, 2002

First Posted

January 27, 2003

Study Start

October 1, 2001

Primary Completion

July 1, 2003

Last Updated

July 16, 2012

Record last verified: 2012-07

Locations

US(1)BE(2)FR(3)