Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information

Basic Trial Information

Objectives

I.  Refine criteria for identifying the population of patients with carcinoma 
of the bladder who can be treated with radiotherapy and chemotherapy with a 
high probability of permanent tumor control.
II.  Evaluate the toxicity of combined radiotherapy and chemotherapy with 
cis-platinum both as preoperative and definitive treatment.
III.  Determine the complete regression rate for all patients on study.
IV.  Determine the degree of pathologic tumor downstaging for patients who 
achieve an incomplete regression with cis-platinum and radiotherapy and 
require cystectomy.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Patients with documented transitional 
cell carcinoma, squamous cell carcinoma, or adenocarcinoma of the bladder who 
have evaluable residual tumor in the bladder following initial TUR and who are 
suitable candidates for radical cystectomy.  Patients must have invasive 
tumors confined to the pelvis that, in the opinion of the urologist, require 
cystectomy.  Disease must be Stage B, C, or D1 (Marshall-Jewett) or T2-4, N0, 
NX, N+ (pelvis) (AJC).  Staging will be clinical, based on examination under 
anesthesia and transurethral resection.  Evidence of tumor spread beyond the 
pelvis, including lymph nodes above the aortic bifurcation, excludes.  
Patients must have a Karnofsky performance status of at least 70%, a serum 
creatinine value of less than 2.0, a 24-hour creatinine clearance of at least 
60 cc/minute, a hemoglobin of greater than 10 g, a WBC of greater than 4,000, 
and platelets greater than 100,000.  Bilirubin, alkaline phosphate, and SGOT 
must be less than twice normal.  Prior radiotherapy, chemotherapy, or surgery 
for bladder carcinoma (other than TUR) excludes.  Patients with clinically 
significant hearing deficit, prior or concurrent other malignancy except 
nonmelanomatous skin cancer, myocardial infarction within the past year, or 
medical problems that might interfere with protocol treatment or follow-up are 
ineligible.

Expected Enrollment

Approximately 74 patients will be accrued to provide 67 evaluable cases.

Outline

Nonrandomized study.  All patients are treated on Regimen A, and those who 
achieve a complete regression proceed to Regimen B.  Patients with incomplete 
regression after Regimen A enter Regimen C.
Regimen A:  Preliminary Radiotherapy plus Single-agent Chemotherapy.  
Irradiation of the bladder and regional lymphatics using effective photon 
energies of 1.25 MeV or higher; plus cis-Platinum, CACP, NSC-119875.
Regimen B:  Consolidation Radiotherapy plus Single-agent Chemotherapy.  
Irradiation of the bladder and extravesical tumor extensions; plus CACP.
Regimen C:  Surgery.  Radical cystectomy.

Tester W, Porter A, Asbell S, et al.: Combined modality program with possible organ preservation for invasive bladder carcinoma: results of RTOG protocol 85-12. Int J Radiat Oncol Biol Phys 25 (5): 783-90, 1993.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Radiation Therapy Oncology Group

William Tester, MD, Protocol chair		Ph: 215-456-8295 Email: testerb@einstein.edu

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