Radiation Therapy With or Without Carbogen and Niacinamide in Treating Patients With Bladder Cancer

• Status: Completed
• Trial end date: 2008-11-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs such as carbogen and niacinamide may make tumor cells more sensitive to radiation therapy. It is not yet known whether radiation therapy is more effective with or without carbogen and niacinamide in treating patients who have bladder cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with or without carbogen and niacinamide in treating patients who have locally advanced bladder cancer.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mount Vernon Cancer Centre at Mount Vernon Hospital
• Treatments: Niacin; Niacinamide; Nicotinic Acids

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed transitional cell carcinoma of the bladder

• Muscle invasive carcinoma (stage T2 or T3) of any grade OR

• High-grade (G3) superficial bladder carcinoma (T1) OR

• Prostatic invasion (T4a)

• No squamous cell carcinoma or adenocarcinoma of the bladder

• No locally advanced T4b carcinoma

• No distant metastasis or enlarged pelvic lymph nodes on CT staging scan of the pelvis

PATIENT CHARACTERISTICS:

Age:

• Over 18

Performance status:

• Not specified

Life expectancy:

• Not specified

Hematopoietic:

• Not specified

Hepatic:

• Bilirubin no greater than 2 times normal

Renal:

• Creatinine no greater than 2 times normal

Cardiovascular:

• No ischemic heart disease or peripheral vascular disease requiring diuretics or angiotensin-converting enzyme inhibitors

Pulmonary:

• No concurrent respiratory disease with reduced respiratory drive that would preclude the delivery of 95% oxygen

Other:

• Capable of complying with a closed breathing system delivering carbogen through either a mask or a mouthpiece with nasal clip

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• Not specified

Endocrine therapy:

• Not specified

Radiotherapy:

• Not specified

Surgery:

• Not specified