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Transurethral Resection and Combination Chemotherapy in Treating Patients With Stage II or Stage III Bladder Cancer

2014-08-27 03:58:35 | BioPortfolio

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combination chemotherapy combined with transurethral resection may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of transurethral resection plus combination chemotherapy in treating patients who have stage II or stage III bladder cancer.

Description

OBJECTIVES: I. Determine the percentage of patients with transitional cell carcinoma of the bladder who are disease free or who have minimal disease 3 months after thorough transurethral resection (TURB) and escalated dose methotrexate/vinblastine/doxorubicin/cisplatin (M-VAC) chemotherapy. II. Evaluate the combination of thorough TURB and escalated dose M-VAC followed by radiotherapy with respect to bladder preservation for patients who respond to neoadjuvant chemotherapy. III. Evaluate the proportion of patients remaining disease free and not requiring cystectomy at 1 year. IV. Evaluate the feasibility and morbidity of this treatment schedule in multiple institutions applied by urologists of possibly varying endoscopic ability.

OUTLINE: This is a multicenter study. Patients undergo a local transurethral resection. Patients then receive methotrexate IV on day 1, followed by vinblastine IV, doxorubicin IV, and cisplatin IV on day 2. Filgrastim (G-CSF) is administered on days 4-10. Chemotherapy is repeated every 14 days for 3 courses. After the end of chemotherapy, patients undergo another local transurethral resection in order to define response to treatment. Patients with minimal or no disease are treated with radiotherapy. Patients who still have disease undergo a cystectomy. Patients are followed every 3 months for the first 2 years, and then every 6 months until death.

PROJECTED ACCRUAL: A total of 29-73 patients will be accrued for this study.

Study Design

Primary Purpose: Treatment

Conditions

Bladder Cancer

Intervention

filgrastim, cisplatin, doxorubicin hydrochloride, methotrexate, vinblastine, surgical procedure, radiation therapy

Location

San Raffaele Hospital
Rome
Italy
00144

Status

Active, not recruiting

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:58:35-0400

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Medical and Biotech [MESH] Definitions

An inorganic and water-soluble platinum complex. After undergoing hydrolysis, it reacts with DNA to produce both intra and interstrand crosslinks. These crosslinks appear to impair replication and transcription of DNA. The cytotoxicity of cisplatin correlates with cellular arrest in the G2 phase of the cell cycle.

An incision made during a surgical procedure.

Changing an operative procedure from an endoscopic surgical procedure to an open approach during the INTRAOPERATIVE PERIOD.

Surgical procedure in which the STOMACH is transected high on the body. The resulting small proximal gastric pouch is joined to any parts of the SMALL INTESTINE by an end-to-side SURGICAL ANASTOMOSIS, depending on the amounts of intestinal surface being bypasses. This procedure is used frequently in the treatment of MORBID OBESITY by limiting the size of functional STOMACH, food intake, and food absorption.

A surgical procedure which diverts pancreatobiliary secretions via the duodenum and the jejunum into the colon, the remaining small intestine being anastomosed to the stomach after antrectomy. The procedure produces less diarrhea than does jejunoileal bypass.

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