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

NCT00033436 | Completed Phase 3

• 3 other identifiers: CDR0000069283MTVERNHOSP-BCONEU-20051
• Study Type: interventional
• Target: 330
• Locations: 1 country
• Sites: 14

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.

Conditions

Bladder Cancer

Keywords

stage I bladder cancer; stage II bladder cancer; stage III bladder cancer; transitional cell carcinoma of the bladder

Outcome Measures

Primary Outcomes (3)

• Cystoscopic response at 6 months after initiation radiotherapy

• Local failure-free survival

• Overall disease-specific survival

Secondary Outcomes (2)

• 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

Interventions

niacinamide DIETARY_SUPPLEMENT

carbogen DRUG

radiation therapy RADIATION

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Mount Vernon Cancer Centre at Mount Vernon Hospital: lead

Study Sites (14)

Sussex Cancer Centre at Royal Sussex County Hospital

Brighton, England, BN2 5BF, United Kingdom

Location

Bristol Haematology and Oncology Centre

Bristol, England, BS2 8ED, United Kingdom

Location

Kent and Canterbury Hospital

Canterbury, England, CT2 3NG, United Kingdom

Location

Derbyshire Royal Infirmary

Derby, England, DE1 2QY, United Kingdom

Location

Ipswich Hospital NHS Trust

Ipswich, England, IP4 5PD, United Kingdom

Location

Cookridge Hospital at Leeds Teaching Hospital NHS Trust

Leeds, England, LS16 6QB, United Kingdom

Location

Christie Hospital NHS Trust

Manchester, England, M20 4BX, United Kingdom

Location

Clatterbridge Centre for Oncology NHS Trust

Merseyside, England, CH63 4JY, United Kingdom

Location

Northern Centre for Cancer Treatment at Newcastle General Hospital

Newcastle upon Tyne, England, NE4 6BE, United Kingdom

Location

Mount Vernon Cancer Centre at Mount Vernon Hospital

Northwood, England, HA6 2RN, United Kingdom

Location

Nottingham City Hospital NHS Trust

Nottingham, England, NG5 1PB, United Kingdom

Location

Oldchurch Hospital

Romford, England, RM7 OBE, United Kingdom

Location

Cancer Research Centre at Weston Park Hospital

Sheffield, England, S1O 2SJ, United Kingdom

Location

Velindre Cancer Center at Velindre Hospital

Cardiff, Wales, CF14 2TL, United Kingdom

Location

Related Publications (2)

• 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.2008.10.001. Epub 2008 Nov 5.

  PMID: 18992952 RESULT

• Choudhury A, Porta N, Hall E, Song YP, Owen R, MacKay R, West CML, Lewis R, Hussain SA, James ND, Huddart R, Hoskin P; BC2001 and BCON investigators. Hypofractionated radiotherapy in locally advanced bladder cancer: an individual patient data meta-analysis of the BC2001 and BCON trials. Lancet Oncol. 2021 Feb;22(2):246-255. doi: 10.1016/S1470-2045(20)30607-0.

  PMID: 33539743 DERIVED

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

Niacinamide; carbogen; Radiotherapy

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Therapeutics

Study Officials

• Peter J. Hoskin, MD

  Mount Vernon Cancer Centre at Mount Vernon Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 9, 2002
• First Posted: January 27, 2003
• Study Start: October 1, 2000
• Study Completion: November 1, 2008
• Last Updated: September 20, 2013

Record last verified: 2002-12

Locations

GB (14)