- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00006111
Surgery Plus Combination Chemotherapy and Radiation Therapy in Treating Patients With Cancer of the Urinary Tract
Multicenter Study of the Quality of Life of Patients With Invasive Urothelial Cancer Treated With Conservative Surgery Followed by Cisplatin, Fluorouracil and Radiotherapy
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 .
Study Overview
Status
Intervention / Treatment
Detailed Description
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.
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.)
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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-
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Avignon, France, 84082
- Institut Sainte Catherine
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Lille, France, 59020
- Centre Oscar Lambret
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Lyon, France, 69373
- Centre Léon Berard
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Montpellier, France, 34298
- Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
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Nice, France, 06189
- Centre Antoine Lacassagne
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Nimes, France, 30006
- C.H.U. - Hopital Gaston Doumergue
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Rennes, France, 35064
- Centre Eugene Marquis
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Saint Cloud, France, 92211
- Centre René Huguenin
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Saint Nazaire, France, 44600
- Centre Hospitalier General de Saint Nazaire
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Toulouse, France, 31052
- Institut Claudius Regaud
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Vandoeuvre-les-Nancy, France, 54511
- Centre Alexis Vautrin
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
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
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: resectable disease
|
|
EXPERIMENTAL: unresectable disease
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Jean-Leon Lagrange, MD, Centre Antoine Lacassagne
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- stage III bladder cancer
- stage IV bladder cancer
- metastatic transitional cell cancer of the renal pelvis and ureter
- urethral cancer associated with invasive bladder cancer
- regional transitional cell cancer of the renal pelvis and ureter
- anterior urethral cancer
- posterior urethral cancer
- stage II bladder cancer
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Urologic Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Kidney Diseases
- Urologic Diseases
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Urinary Bladder Diseases
- Ureteral Diseases
- Urethral Diseases
- Kidney Neoplasms
- Urinary Bladder Neoplasms
- Carcinoma, Transitional Cell
- Ureteral Neoplasms
- Urethral Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Cisplatin
- Fluorouracil
Other Study ID Numbers
- CDR0000068123
- FRE-FNCLCC-97015
- EU-20009
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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