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Home > "R" Clinical Trials Conditions > Radiation Therapy With or Without Carbogen and Niacinamide in Treating Patients With Bladder Cancer

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



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

For Condition: stage 1 bladder cancer,stage 3 bladder cancer,transitional cell carcinoma of the bladder,stage 2 bladder cancer
Status: Recruiting
Sponsor(s): Mount Vernon Hospital ,
Synopsis: 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: Randomizedphase III trial to compare the effectiveness of radiation therapy with or without carbogen and niacinamide in treating patients who have locally advanced bladder cancer.
Details: 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. PROJECTED ACCRUAL: A total of 330 patients (165 per treatment arm) will be accrued for this study.
Eligibility:
Study Type:
  Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
PeterHoskin,  Study Chair,  Mount Vernon Hospital

Mount Vernon Hospital *Recruiting*
Northwood,  England,  HA6 2RN
United Kingdom
Recruiting Peter  Hoskin 44-019-2384-4533

Kent and Canterbury Hospital *Recruiting*
Canterbury,  England,  CT2 3NG
United Kingdom
Recruiting Natasha  Mithal 44-12-776-6877

Clatterbridge Centre for Oncology NHS Trust *Recruiting*
Merseyside,  England,  CH63 4JY
United Kingdom
Recruiting I.  Syndikus 44-151-334-1155

Northern Centre for Cancer Treatment at Newcastle General Hospital *Recruiting*
Newcastle upon Tyne,  England,  NE4 6BE
United Kingdom
Recruiting Rhona  McMenemin 44-191-219-4200

Oldchurch Hospital *Recruiting*
Romford,  England,  RM7 OBE
United Kingdom
Recruiting Stephanie  Gibbs 44-1780-34-5533

Weston Park Hospital *Recruiting*
Sheffield,  England,  S1O 2SJ
United Kingdom
Recruiting Peter  Kirkbride 44-114-226-5000

Ipswich Hospital NHS Trust *Recruiting*
Ipswich,  England,  IP4 5PD
United Kingdom
Recruiting Christopher  Scrase 44-147-370-4177

Royal Sussex County Hospital *Recruiting*
Brighton,  England,  BN2 5BF
United Kingdom
Recruiting David  Bloomfield 44-1273-696-955 ext. 7686

Nottingham City Hospital NHS Trust *Recruiting*
Nottingham,  England,  NG5 1PB
United Kingdom
Recruiting Michael  Sokal 44-115-969-1169

Bristol Haematology and Oncology Centre *Recruiting*
Bristol,  England,  BS2 8ED
United Kingdom
Recruiting John  Graham 44-117-928-2409

Christie Hospital N.H.S. Trust *Recruiting*
Manchester,  England,  M20 4BX
United Kingdom
Recruiting John  Logue 44-161-446-3000

Derbyshire Royal Infirmary *Recruiting*
Derby,  England,  DE1 2QY
United Kingdom
Recruiting Prabir  Chakraborti 44-1332-254843

Velindre Cancer Center at Velinde Hospital *Recruiting*
Cardiff,  Wales,  CF14 2TL
United Kingdom
Recruiting Jim  Barber 44-29-2061-5888

Cookridge Hospital at Leeds Teaching Hospital NHS Trust *Recruiting*
Leeds,  England,  LS16 6QB
United Kingdom
Recruiting David  Bottomley 44-113-267-3411


Additional Information:
Study ID Numbers:
  CDR0000069283;  MTVERNHOSP-BCON,EU-20051
Study Start Date: 
Record last reviewed: April 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00033436

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