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Radiation Therapy and Fluorouracil Before Surgery in Treating Patients With Primary or Recurrent Bile Duct Cancer Clinical Trials Information presented on Clinical Trials Search is not intended to be a substitute for qualified health advice, trips or treatment by using a genuine doctor. We aren't doctors. Always consult your mD on Radiation Therapy and Fluorouracil Before Surgery in Treating Patients With Primary or Recurrent Bile Duct Cancer conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. Radiation Therapy and Fluorouracil Before Surgery in Treating Patients With Primary or Recurrent Bile Duct Cancer Clinical research trials and Radiation Therapy and Fluorouracil Before Surgery in Treating Patients With Primary or Recurrent Bile Duct Cancer health trials take place in a lot of of cities across the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the potency of new drugs. The aim of the studies / projects is to answer specific human medical questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, like Radiation Therapy and Fluorouracil Before Surgery in Treating Patients With Primary or Recurrent Bile Duct Cancer. Radiation Therapy and Fluorouracil Before Surgery in Treating Patients With Primary or Recurrent Bile Duct Cancer Clinical Trials and other clinical trials allow for volunteers to have health treatment alternatives before they are available to the general public. Many times the test subjects obtain treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a Radiation Therapy and Fluorouracil Before Surgery in Treating Patients With Primary or Recurrent Bile Duct Cancer clinical trial. Subjects oftentimes recieve the most effective healthcare possible for their Radiation Therapy and Fluorouracil Before Surgery in Treating Patients With Primary or Recurrent Bile Duct Cancer condition. Hazards are a reality, however, and could include additional or frequent doctor visits, healthcare dangers (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
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Home > "R" Clinical Trials Conditions > Radiation Therapy and Fluorouracil Before Surgery in Treating Patients With Primary or Recurrent Bile Duct Cancer  Radiation Therapy and Fluorouracil Before Surgery in Treating Patients With Primary or Recurrent Bile Duct Cancer
Radiation Therapy and Fluorouracil Before Surgery in Treating Patients With Primary or Recurrent Bile Duct Cancer
For Condition: recurrent extrahepatic bile duct cancer,localized extrahepatic bile duct cancer,localized resectable adult primary liver cancer,recurrent adult primary liver cancer
Status: No longer recruiting
Sponsor(s): EORTC Chronotherapy Study Group ,
Synopsis: 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.
Details: 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:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
TyvinRich, , University of Virginia, Health Sciences Center Cancer Center
Centre Hospital Regional Universitaire de Limoges
Limoges, , 87042
France
Les Cliniques Saint-Joseph ASBL
LIEGE, , B 4000
Belgium
Hopital Paul Brousse
Villejuif, , 94804
France
Hopital Cochin
Paris, , 75674
France
Hopital de Jolimont
Haine-Saint-Paul, , 7100
Belgium
Cancer Center at the University of Virginia
Charlottesville, Virginia, 22908
United States
Additional Information:
Study ID Numbers: CDR0000069171; EORTC-05991
Study Start Date:
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00030511
Other Recurrent Extrahepatic Bile Duct Cancer Studies:
1. SCH 66336 With or Without Gemcitabine Followed by Surgery Compared With Surgery Alone in Treating Patients With Primary Liver Cancer
2. DX-8951f in Treating Patients With Liver Cancer
3. Vaccine Therapy in Treating Patients With Liver Cancer
4. Radioactive Iodine in Treating Patients Who Have Undergone Surgery for Liver Cancer
5. Vaccine Therapy in Treating Patients With Liver Cancer
Related Studies:
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Radiation Therapy and Fluorouracil Before Surgery in Treating Patients With Primary or Recurrent Bile Duct Cancer
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