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Bladder CancerPhase 3NCT00033436

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

A Phase 3 study testing niacinamide, carbogen and radiation therapy in people with Bladder Cancer, run by Mount Vernon Cancer Centre at Mount Vernon Hospital at 14 sites in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Bladder Cancer
What is being tested?
niacinamide, carbogen and radiation therapy
Type of treatment
Surgery or procedure
How many people
330 participants
Where
14 sitesUnited Kingdom
Study dates
Oct 2000to Nov 2008
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

14 sites in 1 country.

14 sites in 1 country

United Kingdom14 sites

  • Sussex Cancer Centre at Royal Sussex County Hospital

    Brighton, England, BN2 5BF

  • Bristol Haematology and Oncology Centre

    Bristol, England, BS2 8ED

  • Kent and Canterbury Hospital

    Canterbury, England, CT2 3NG

  • Velindre Cancer Center at Velindre Hospital

    Cardiff, Wales, CF14 2TL

  • Derbyshire Royal Infirmary

    Derby, England, DE1 2QY

  • Ipswich Hospital NHS Trust

    Ipswich, England, IP4 5PD

  • Cookridge Hospital at Leeds Teaching Hospital NHS Trust

    Leeds, England, LS16 6QB

  • Christie Hospital NHS Trust

    Manchester, England, M20 4BX

  • Clatterbridge Centre for Oncology NHS Trust

    Merseyside, England, CH63 4JY

  • Northern Centre for Cancer Treatment at Newcastle General Hospital

    Newcastle upon Tyne, England, NE4 6BE

  • Mount Vernon Cancer Centre at Mount Vernon Hospital

    Northwood, England, HA6 2RN

  • Nottingham City Hospital NHS Trust

    Nottingham, England, NG5 1PB

  • Oldchurch Hospital

    Romford, England, RM7 OBE

  • Cancer Research Centre at Weston Park Hospital

    Sheffield, England, S1O 2SJ

Other trials in United Kingdom

About this study

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

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.

Read the 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.

Conditions
Bladder Cancer
Being tested
niacinamide, carbogen, radiation therapy
Keywords
stage I bladder cancer, stage II bladder cancer, stage III bladder cancer, transitional cell carcinoma of the bladder
Medical subject headings
Urinary Bladder Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • niacinamideDietary supplement

  • carbogenDrug

  • radiation therapyRadiation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cystoscopic response at 6 months after initiation radiotherapy

  2. Local failure-free survival

  3. Overall disease-specific survival

Secondary outcomes (2)

  1. Treatment related morbidity (i.e., acute and chronic bowel and bladder symptoms)

  2. 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2003 (estimated)
  2. Study startOct 2000
  3. Study completionNov 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Enrolment
330 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00033436
Sponsor's protocol ID
CDR0000069283
Other IDs
MTVERNHOSP-BCON, EU-20051
Status last verified
Dec 2002
First submitted
9 Apr 2002
Last updated
20 Sep 2013
Results posted
No

Publications

  • 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.

    PubMed 18992952

  • 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.

    PubMed 33539743

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing niacinamide, carbogen and radiation therapy in people with Bladder Cancer, run by Mount Vernon Cancer Centre at Mount Vernon Hospital at 14 sites in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cystoscopic response at 6 months after initiation radiotherapy. The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00033436, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2013.

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