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

Sponsor

European Organisation for Research and Treatment of Cancer - EORTC (Other)

Overall Status

Terminated

CT.gov ID

NCT00030511

Collaborator

(none)

Locations

Study Details

Study Description

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.

Study Design

Study Type:

Interventional

Primary Purpose:

Treatment

Official Title:

A Phase II Study of Chronomodulated Preoperative Infusional Chemoradiation for Biliary Tract Cancer

Study Start Date :

Oct 1, 2001

Actual Primary Completion Date :

Jul 1, 2003

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Cancer Center at the University of Virginia	Charlottesville	Virginia	United States	22908
2	Hopital de Jolimont	Haine Saint Paul		Belgium	7100
3	Les Cliniques Saint-Joseph ASBL	Liege		Belgium	B 4000
4	Centre Hospital Regional Universitaire de Limoges	Limoges		France	87042
5	Hopital Cochin	Paris		France	75674
6	Hopital Paul Brousse	Villejuif		France	94804