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

Study Overview
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Brief Summary
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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.

Detailed Description
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OBJECTIVES: Compare the 6-month cystoscopic response in patients with locally advanced transitional cell carcinoma of the bladder treated with radical radiotherapy with or without radiosensitization with carbogen and niacinamide. Compare the local failure-free and overall disease-specific survival of patients treated with these regimens. Compare the treatment-related morbidity, in particular acute and chronic bowel and bladder symptoms, in patients treated with these regimens. Compare the quality of life of patients treated with these regimens. OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms. Arm I: Patients receive radical radiotherapy once daily, 5 days a week, for 4-6.4 weeks. Patients also receive oral niacinamide once daily 1.5-2 hours before initiation of each radiotherapy dose and carbogen through a closed breathing system (face mask with a tight air seal or a mouthpiece with nasal clip) once daily beginning 5 minutes before initiation and continuing until completion of each radiotherapy dose. Arm II: Patients receive radiotherapy as in arm I. Quality of life is assessed at baseline; at 4 weeks; at 3, 6, and 12 months; and then annually for 4 years. Patients are followed at 8 and 12 weeks; at 6, 9, and 12 months; and then every 6 months for 4 years. Peer Reviewed and Funded or Endorsed by Cancer Research UK PROJECTED ACCRUAL: A total of 330 patients (165 per treatment arm) will be accrued for this study.

Official Title
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A Multicenter Randomized Trial of Radical Radiotherapy With Carbogen in the Radical Treatment of Locally Advanced Bladder Cancer

Conditions
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Bladder Cancer

Intervention / Treatment
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* Dietary Supplement: niacinamide
* Drug: carbogen
* Radiation: radiation therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized


Arms and Interventions

| Intervention/Treatment |
| --- |
|Dietary Supplement: niacinamide|nan|
|Drug: carbogen|nan|
|Radiation: radiation therapy|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cystoscopic response at 6 months after initiation radiotherapy |  |  | 
| Local failure-free survival |  |  | 
| Overall disease-specific survival |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment related morbidity (i.e., acute and chronic bowel and bladder symptoms) |  |  | 
| Quality of life as assessed by FACT-BI scale at baseline, week 4, 3 months, 6 months, 12 months, and yearly thereafter for 5 years |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage I bladder cancer, stage II bladder cancer, stage III bladder cancer, transitional cell carcinoma of the bladder