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Surgery Plus Combination Chemotherapy and Radiation Therapy in Treating Patients With Cancer of the Urinary Tract Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified medical advice, visits or professional assistance with a genuine dr.. We are not doctors. Always consult your mD about Surgery Plus Combination Chemotherapy and Radiation Therapy in Treating Patients With Cancer of the Urinary Tract conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Surgery Plus Combination Chemotherapy and Radiation Therapy in Treating Patients With Cancer of the Urinary Tract Clinical research trials and Surgery Plus Combination Chemotherapy and Radiation Therapy in Treating Patients With Cancer of the Urinary Tract medical trials take place in many of places throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the effectiveness of new does drugs. The purpose of the studies / projects is to solve specific human healthcare questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to find cures for all varieties of conditions, like Surgery Plus Combination Chemotherapy and Radiation Therapy in Treating Patients With Cancer of the Urinary Tract. Surgery Plus Combination Chemotherapy and Radiation Therapy in Treating Patients With Cancer of the Urinary Tract Clinical Trials and other clinical trials allow for volunteers to have health treatment options before they are available to the masses. Many times the human subjects acquire professional assistance for free of charge, and sometimes they are compensated for their time. Occasionally there is a cost for a Surgery Plus Combination Chemotherapy and Radiation Therapy in Treating Patients With Cancer of the Urinary Tract clinical trial. Test subjects typically obtain the finest healthcare available for their Surgery Plus Combination Chemotherapy and Radiation Therapy in Treating Patients With Cancer of the Urinary Tract condition. Dangers are a reality, nevertheless, and might include additional or frequent doctor trips, medical dangers (possibly life-jeopardising), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials patients.
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Home > "S" Clinical Trials Conditions > Surgery Plus Combination Chemotherapy and Radiation Therapy in Treating Patients With Cancer of the Urinary Tract  Surgery Plus Combination Chemotherapy and Radiation Therapy in Treating Patients With Cancer of the Urinary Tract
Surgery Plus Combination Chemotherapy and Radiation Therapy in Treating Patients With Cancer of the Urinary Tract
For Condition: stage 4 bladder cancer,metastatic transitional cell cancer of the renal pelvis and ureter,anterior urethral cancer,stage 2 bladder cancer,urethral cancer associated with invasive bladder cancer,stage 3 bladder cancer,regional transitional cell cancer of the renal pelvis and ureter,posterior urethral cancer
Status: No longer recruiting
Sponsor(s): Federation Nationale des Centres de Lutte Contre le Cancer ,
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining surgery with chemotherapy and radiation therapy may be an effective way to treat cancer of the urinary tract. PURPOSE: Phase II trial to study the effectiveness of combining surgery, chemotherapy and radiation therapy in treating patients who have stage II, stage III, or stage IV cancer of the urinary tract.
Details: OBJECTIVES: I. Assess the quality of life of patients with invasive stage II, III, or IV carcinoma of the urothelium treated with conservative surgery plus cisplatin, fluorouracil, and radiotherapy. II. Determine the efficacy of this regimen, in terms of local control, in these patients. III. Determine survival of patients treated with this regimen. IV. Determine the toxic effects of this regimen in these patients. PROTOCOL OUTLINE: This is a multicenter study. Patients are stratified according to tumor type (T2-4a, N0, M0; potentially resectable; no contraindication to surgery vs T2-4b, N0 or N1 or pN1, M0; refused surgery or medical contraindications to surgery). (Accrual for stratum I was completed as of 10/23/2001.) Stratum I (resectable disease): Regimen A: Patients undergo radiotherapy 5 days a week for 5 weeks. Patients also receive fluorouracil IV continuously and cisplatin IV continuously on days 1-4 during weeks 1 and 4. If complete response is achieved by week 5, patients proceed to regimen B. If partial response or progression is observed, patients undergo cystectomy. If cystectomy is refused, patients proceed to regimen B. Regimen B: Patients undergo radiotherapy 5 days a week for 2 weeks. Patients also receive fluorouracil and cisplatin as in regimen A on weeks 2 and 5. (Accrual for stratum I was completed as of 10/23/2001.) Stratum II (unresectable disease): Patients undergo radiotherapy 5 days a week for 7 weeks. Patients also receive fluorouracil and cisplatin as in regimen A on weeks 1, 4, and 7. Quality of life is assessed at baseline, at 6 months, and then at 1 year. Patients are followed at 6-8 weeks, every 6 months for 2 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 75 patients (35 for stratum I and 40 for stratum II) will be accrued for this study. (Accrual for stratum I was completed as of 10/23/2001.)
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/70 Years
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically confirmed stage II, III, or IV carcinoma of the urothelium infiltrating muscle; Primary OR After development of a superficial tumor; T2-T4b with or without lymph node involvement and no detectable metastases - No epidermoid cancer or adenocarcinoma - No extrapelvic lymph node involvement --Prior/Concurrent Therapy-- - Biologic therapy: Not specified - Chemotherapy: No prior chemotherapy except intravesicular instillations - Endocrine therapy: Not specified - Radiotherapy: No prior radiotherapy - Surgery: Not specified --Patient Characteristics-- - Age: 18 to 70 - Performance status: WHO 0-2 - Life expectancy: More than 6 months - Hematopoietic: WBC greater than 4,000/mm3; Platelet count greater than 100,000/mm3; Neutrophil count greater than 1,500/mm3; Hemoglobin greater than 10 g/dL - Hepatic: Not specified - Renal: Creatinine less than 1.5 mg/dL - Other: Not pregnant; Fertile patients must use effective contraception during and for 2 months after study; No other prior malignancy except nonmelanomatous skin cancer or carcinoma in situ of the cervix; No prior serious illness of the gastrointestinal tract (e.g., rectal bleeding or diverticulosis with complications); No contraindication to fluorouracil, cisplatin, or radiotherapy
Total Enrollment:
Location and Contact Information:
Overall Study Official:
Jean-LeonLagrange, Study Chair, Federation Nationale des Centres de Lutte Contre le Cancer
Centre Leon Berard
Lyon, , 69373
France
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
Montpellier, , 34298
France
Centre Antoine Lacassagne
Nice, , 06189
France
Institut Sainte Catherine
Avignon, , 84082
France
Centre Oscar Lambret
Lille, , 59020
France
Institut Claudius Regaud
Toulouse, , 31052
France
Centre Rene Huguenin
Saint Cloud, , 92211
France
C.H.U. - Hopital Gaston Doumergue
Nimes, , 30006
France
Centre Eugene Marquis
Rennes, , 35064
France
Centre Hospitalier General de Saint Nazaire
Saint-Nazaire, , 44600
France
Centre Alexis Vautrin
Vandoeuvre-les-Nancy, , 54511
France
Additional Information:
Study ID Numbers: CDR0000068123; EU-20009,FRE-FNCLCC-97015
Study Start Date: April 1999
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006111
Other Stage 2 Bladder Cancer Studies:
1. Radiation Therapy and Chemotherapy Following Surgery in Treating Patients With Stage II or Stage III Bladder Cancer
2. Gene Therapy in Treating Patients With Advanced Bladder Cancer
3. Gemcitabine, Cisplatin, and Amifostine Following Surgery in Treating Patients With Locally Advanced Bladder Cancer
4. Combination Chemotherapy and Radiation Therapy With or Without Surgery In Treating Patients With Stage II or Stage III Bladder Cancer
5. Cisplatin and Gemcitabine Compared With Observation in Treating Patients Who Have Undergone Surgery for Bladder Cancer
Related Studies:
Other stage 2 bladder cancer Clinical Trials
Other Clinical Trials
Other Saint-Nazaire Clinical Trials
Surgery Plus Combination Chemotherapy and Radiation Therapy in Treating Patients With Cancer of the Urinary Tract
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