Surgery Plus Combination Chemotherapy and Radiation Therapy in Treating Patients With Cancer of the Urinary Tract
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| ClinicalTrials.gov Identifier: NCT00006111 |
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Recruitment Status :
Completed
First Posted : February 3, 2004
Last Update Posted : February 21, 2021
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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 .
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Bladder Cancer Transitional Cell Cancer of the Renal Pelvis and Ureter Urethral Cancer | Drug: cisplatin Drug: fluorouracil Procedure: conventional surgery Radiation: radiation therapy | Phase 2 |
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 : | Interventional (Clinical Trial) |
| Actual Enrollment : | 53 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Multicenter Study of the Quality of Life of Patients With Invasive Urothelial Cancer Treated With Conservative Surgery Followed by Cisplatin, Fluorouracil and Radiotherapy |
| Actual Study Start Date : | April 1999 |
| Actual Primary Completion Date : | January 2003 |
| Actual Study Completion Date : | June 2008 |
| Arm | Intervention/treatment |
|---|---|
| Experimental: resectable disease |
Drug: cisplatin Drug: fluorouracil Procedure: conventional surgery Radiation: radiation therapy |
| Experimental: unresectable disease |
Drug: cisplatin Drug: fluorouracil Radiation: radiation therapy |
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| Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00006111
| France | |
| Institut Sainte Catherine | |
| Avignon, France, 84082 | |
| Centre Oscar Lambret | |
| Lille, France, 59020 | |
| Centre Leon Berard | |
| Lyon, France, 69373 | |
| Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle | |
| Montpellier, France, 34298 | |
| Centre Antoine Lacassagne | |
| Nice, France, 06189 | |
| C.H.U. - Hopital Gaston Doumergue | |
| Nimes, France, 30006 | |
| Centre Eugene Marquis | |
| Rennes, France, 35064 | |
| Centre Rene Huguenin | |
| Saint Cloud, France, 92211 | |
| Centre Hospitalier General de Saint Nazaire | |
| Saint Nazaire, France, 44600 | |
| Institut Claudius Regaud | |
| Toulouse, France, 31052 | |
| Centre Alexis Vautrin | |
| Vandoeuvre-les-Nancy, France, 54511 | |
| Study Chair: | Jean-Leon Lagrange, MD | Centre Antoine Lacassagne |
| Responsible Party: | UNICANCER |
| ClinicalTrials.gov Identifier: | NCT00006111 |
| Other Study ID Numbers: |
CDR0000068123 FRE-FNCLCC-97015 EU-20009 |
| First Posted: | February 3, 2004 Key Record Dates |
| Last Update Posted: | February 21, 2021 |
| Last Verified: | February 2021 |
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stage II bladder cancer stage III bladder cancer stage IV bladder cancer anterior urethral cancer |
posterior urethral cancer urethral cancer associated with invasive bladder cancer metastatic transitional cell cancer of the renal pelvis and ureter regional transitional cell cancer of the renal pelvis and ureter |
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Urinary Bladder Neoplasms Urethral Neoplasms Carcinoma, Transitional Cell Kidney Neoplasms Ureteral Neoplasms Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Neoplasms Urinary Bladder Diseases Urologic Diseases Urethral Diseases Carcinoma |
Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Kidney Diseases Ureteral Diseases Cisplatin Fluorouracil Antineoplastic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Antimetabolites, Antineoplastic Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |