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

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00033436
First received: April 9, 2002
Last updated: September 19, 2013
Last verified: December 2002
  Purpose

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.


Condition Intervention Phase
Bladder Cancer
Dietary Supplement: niacinamide
Drug: carbogen
Radiation: radiation therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
Official Title: A Multicenter Randomized Trial of Radical Radiotherapy With Carbogen in the Radical Treatment of Locally Advanced Bladder Cancer

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Cystoscopic response at 6 months after initiation radiotherapy [ Designated as safety issue: No ]
  • Local failure-free survival [ Designated as safety issue: No ]
  • Overall disease-specific survival [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Treatment related morbidity (i.e., acute and chronic bowel and bladder symptoms) [ Designated as safety issue: No ]
  • 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 [ Designated as safety issue: No ]

Estimated Enrollment: 330
Study Start Date: October 2000
Study Completion Date: November 2008
Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00033436

Locations
United Kingdom
Sussex Cancer Centre at Royal Sussex County Hospital
Brighton, England, United Kingdom, BN2 5BF
Bristol Haematology and Oncology Centre
Bristol, England, United Kingdom, BS2 8ED
Kent and Canterbury Hospital
Canterbury, England, United Kingdom, CT2 3NG
Derbyshire Royal Infirmary
Derby, England, United Kingdom, DE1 2QY
Ipswich Hospital NHS Trust
Ipswich, England, United Kingdom, IP4 5PD
Cookridge Hospital at Leeds Teaching Hospital NHS Trust
Leeds, England, United Kingdom, LS16 6QB
Christie Hospital NHS Trust
Manchester, England, United Kingdom, M20 4BX
Clatterbridge Centre for Oncology NHS Trust
Merseyside, England, United Kingdom, CH63 4JY
Northern Centre for Cancer Treatment at Newcastle General Hospital
Newcastle-Upon-Tyne, England, United Kingdom, NE4 6BE
Mount Vernon Cancer Centre at Mount Vernon Hospital
Northwood, England, United Kingdom, HA6 2RN
Nottingham City Hospital NHS Trust
Nottingham, England, United Kingdom, NG5 1PB
Oldchurch Hospital
Romford, England, United Kingdom, RM7 OBE
Cancer Research Centre at Weston Park Hospital
Sheffield, England, United Kingdom, S1O 2SJ
Velindre Cancer Center at Velindre Hospital
Cardiff, Wales, United Kingdom, CF14 2TL
Sponsors and Collaborators
Mount Vernon Cancer Centre at Mount Vernon Hospital
Investigators
Study Chair: Peter J. Hoskin, MD Mount Vernon Cancer Centre at Mount Vernon Hospital
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00033436     History of Changes
Other Study ID Numbers: CDR0000069283, MTVERNHOSP-BCON, EU-20051
Study First Received: April 9, 2002
Last Updated: September 19, 2013
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage I bladder cancer
stage II bladder cancer
stage III bladder cancer
transitional cell carcinoma of the bladder

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Niacinamide
Niacin
Nicotinic Acids
Carbogen
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on July 28, 2014