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

Bladder Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00033436
• Other study ID #: CDR0000069283
• Secondary ID: MTVERNHOSP-BCONE
• Status: Completed
• Phase: Phase 3
• First received: April 9, 2002
• Last updated: September 19, 2013
• Start date: October 2000
• Est. completion date: November 2008

Study information

• Verified date: December 2002
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 330
• Est. completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bladder Cancer
• Urinary Bladder Neoplasms

Intervention

Dietary Supplement:
• niacinamide

Drug:
• carbogen

Radiation:
• radiation therapy

Locations

Country	Name	City	State
United Kingdom	Sussex Cancer Centre at Royal Sussex County Hospital	Brighton	England
United Kingdom	Bristol Haematology and Oncology Centre	Bristol	England
United Kingdom	Kent and Canterbury Hospital	Canterbury	England
United Kingdom	Velindre Cancer Center at Velindre Hospital	Cardiff	Wales
United Kingdom	Derbyshire Royal Infirmary	Derby	England
United Kingdom	Ipswich Hospital NHS Trust	Ipswich	England
United Kingdom	Cookridge Hospital at Leeds Teaching Hospital NHS Trust	Leeds	England
United Kingdom	Christie Hospital NHS Trust	Manchester	England
United Kingdom	Clatterbridge Centre for Oncology NHS Trust	Merseyside	England
United Kingdom	Northern Centre for Cancer Treatment at Newcastle General Hospital	Newcastle-Upon-Tyne	England
United Kingdom	Mount Vernon Cancer Centre at Mount Vernon Hospital	Northwood	England
United Kingdom	Nottingham City Hospital NHS Trust	Nottingham	England
United Kingdom	Oldchurch Hospital	Romford	England
United Kingdom	Cancer Research Centre at Weston Park Hospital	Sheffield	England

Sponsors (1)

Lead Sponsor	Collaborator
Mount Vernon Cancer Centre at Mount Vernon Hospital

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

Hoskin PJ, Rojas AM, Saunders MI, Bentzen SM, Motohashi KJ; BCON investigators. Carbogen and nicotinamide in locally advanced bladder cancer: early results of a phase-III randomized trial. Radiother Oncol. 2009 Apr;91(1):120-5. doi: 10.1016/j.radonc.2008. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cystoscopic response at 6 months after initiation radiotherapy			No
Primary	Local failure-free survival			No
Primary	Overall disease-specific survival			No
Secondary	Treatment related morbidity (i.e., acute and chronic bowel and bladder symptoms)			No
Secondary	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			No