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

Sponsor

Mount Vernon Cancer Centre at Mount Vernon Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT00033436

Collaborator

(none)

330

Enrollment

Locations

Duration (Months)

23.6

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Bladder Cancer	Dietary Supplement: niacinamide Drug: carbogen Radiation: radiation therapy	Phase 3

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

330 participants

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

Study Start Date :

Oct 1, 2000

Actual Study Completion Date :

Nov 1, 2008

Outcome Measures

Primary Outcome Measures

Cystoscopic response at 6 months after initiation radiotherapy []
Local failure-free survival []
Overall disease-specific survival []

Secondary Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Sussex Cancer Centre at Royal Sussex County Hospital	Brighton	England	United Kingdom	BN2 5BF
2	Bristol Haematology and Oncology Centre	Bristol	England	United Kingdom	BS2 8ED
3	Kent and Canterbury Hospital	Canterbury	England	United Kingdom	CT2 3NG
4	Derbyshire Royal Infirmary	Derby	England	United Kingdom	DE1 2QY
5	Ipswich Hospital NHS Trust	Ipswich	England	United Kingdom	IP4 5PD
6	Cookridge Hospital at Leeds Teaching Hospital NHS Trust	Leeds	England	United Kingdom	LS16 6QB
7	Christie Hospital NHS Trust	Manchester	England	United Kingdom	M20 4BX
8	Clatterbridge Centre for Oncology NHS Trust	Merseyside	England	United Kingdom	CH63 4JY
9	Northern Centre for Cancer Treatment at Newcastle General Hospital	Newcastle-Upon-Tyne	England	United Kingdom	NE4 6BE
10	Mount Vernon Cancer Centre at Mount Vernon Hospital	Northwood	England	United Kingdom	HA6 2RN
11	Nottingham City Hospital NHS Trust	Nottingham	England	United Kingdom	NG5 1PB
12	Oldchurch Hospital	Romford	England	United Kingdom	RM7 OBE
13	Cancer Research Centre at Weston Park Hospital	Sheffield	England	United Kingdom	S1O 2SJ
14	Velindre Cancer Center at Velindre Hospital	Cardiff	Wales	United Kingdom	CF14 2TL