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

Last updated: September 19, 2013
Sponsor: Mount Vernon Cancer Centre at Mount Vernon Hospital
Overall Status: Completed

Phase

3

Condition

Bladder Cancer

Urothelial Carcinoma

Urothelial Cancer

Treatment

N/A

Clinical Study ID

NCT00033436
CDR0000069283
EU-20051
MTVERNHOSP-BCON
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

Study Design

Total Participants: 330
Study Start date:
October 01, 2000
Estimated Completion Date:
November 30, 2008

Study Description

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.

Connect with a study center

  • Sussex Cancer Centre at Royal Sussex County Hospital

    Brighton, England BN2 5BF
    United Kingdom

    Site Not Available

  • Bristol Haematology and Oncology Centre

    Bristol, England BS2 8ED
    United Kingdom

    Site Not Available

  • Kent and Canterbury Hospital

    Canterbury, England CT2 3NG
    United Kingdom

    Site Not Available

  • Derbyshire Royal Infirmary

    Derby, England DE1 2QY
    United Kingdom

    Site Not Available

  • Ipswich Hospital NHS Trust

    Ipswich, England IP4 5PD
    United Kingdom

    Site Not Available

  • Cookridge Hospital at Leeds Teaching Hospital NHS Trust

    Leeds, England LS16 6QB
    United Kingdom

    Site Not Available

  • Christie Hospital NHS Trust

    Manchester, England M20 4BX
    United Kingdom

    Site Not Available

  • Clatterbridge Centre for Oncology NHS Trust

    Merseyside, England CH63 4JY
    United Kingdom

    Site Not Available

  • Northern Centre for Cancer Treatment at Newcastle General Hospital

    Newcastle-Upon-Tyne, England NE4 6BE
    United Kingdom

    Site Not Available

  • Mount Vernon Cancer Centre at Mount Vernon Hospital

    Northwood, England HA6 2RN
    United Kingdom

    Site Not Available

  • Nottingham City Hospital NHS Trust

    Nottingham, England NG5 1PB
    United Kingdom

    Site Not Available

  • Oldchurch Hospital

    Romford, England RM7 OBE
    United Kingdom

    Site Not Available

  • Cancer Research Centre at Weston Park Hospital

    Sheffield, England S1O 2SJ
    United Kingdom

    Site Not Available

  • Velindre Cancer Center at Velindre Hospital

    Cardiff, Wales CF14 2TL
    United Kingdom

    Site Not Available

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