Bladder CancerPhase 3NCT00002490
Radiation Therapy, Chemotherapy, or Observation in Treating Patients With Bladder Cancer
A Phase 3 study testing BCG vaccine, mitomycin C and radiation therapy in people with Bladder Cancer, run by Medical Research Council at 1 site in United Kingdom.
Trial summary
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with radiation therapy may kill more tumor cells. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- BCG vaccine, mitomycin C and radiation therapy
- Type of treatment
- Vaccines, Surgery or procedure
- How many people
- Not given
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 1991to not given
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
DISEASE CHARACTERISTICS:
- Diagnosis of transitional cell carcinoma of the bladder
- Stage T1 Nx M0, grade 3 disease
- No muscle invasion at base of tumor
- Diagnosis of this stage made within the past 6 months
- Earlier diagnosis of tumors with lower stage or grade allowed
- No history of higher stage urothelial tumors
- Presence of partial involvement of bladder with carcinoma in situ (CIS) or asymptomatic widespread CIS allowed
- No widespread CIS causing severe symptoms
- Prior complete transurethral resection of tumor with deep biopsy of underlying bladder wall required
- Disease currently amenable to adjuvant radiotherapy, followed by cystoscopy with biopsies
PATIENT CHARACTERISTICS:
Age:
- Any age
Performance status:
- WHO 0-2
Life expectancy:
- Not specified
Hematopoietic:
- Not specified
Hepatic:
- Not specified
Renal:
- Not specified
Other:
- No other prior or concurrent malignancy except nonmelanomatous skin cancer or cervical intraepithelial neoplasia
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No more than 1 prior adjuvant treatment with intravesical BCG
Chemotherapy:
- No more than 1 prior adjuvant treatment with intravesical chemotherapy
Endocrine therapy:
- Not specified
Radiotherapy:
- See Disease Characteristics
Surgery:
- See Disease Characteristics
- Diathermic removal of associated small papillary growths allowed
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Middlesex Hospital- Meyerstein Institute
London, England, WIT 3AA
About this study
Official title: A RANDOMIZED TRIAL OF RADICAL RADIOTHERAPY IN pT1G3 NXM0 BLADDER CANCER
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with radiation therapy may kill more tumor cells. It is not known whether receiving either radiation therapy, chemotherapy, or observation is more effective for cancer of the bladder.
PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy, chemotherapy, or observation following tumor surgery in treating patients who have bladder cancer.
Read the detailed description
OBJECTIVES:
- Compare the efficacy of adjuvant radical radiotherapy vs intravesical BCG or mitomycin vs observation alone after endoscopic resection in terms of the progression rate and survival of patients with stage I, grade 3 transitional cell carcinoma of the bladder.
- Determine the toxicity of radical radiotherapy in these patients.
- Determine the incidence of carcinoma in situ elsewhere in the bladder and its correlation with the subsequent clinical outcome of these patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to center, extent of tumor (single tumor without carcinoma in situ (CIS) vs multiple tumors or CIS), and WHO performance status. Patients with a single tumor and no CIS are randomized to arm I or II. Patients with multiple tumors or CIS are randomized to arm II or III.
- Arm I: Patients undergo observation only.
- Arm II: Patients undergo radical radiotherapy 5 days a week for 6 weeks. Patients found to be node positive on CT scan may undergo pelvic irradiation and remain on study.
- Arm III: Patients receive intravesical BCG or mitomycin (at the discretion of the physician) weekly for 6-12 weeks.
Patients on arms I and III are followed at 3 months after randomization. All patients are followed at 6, 9, and 12 months and then annually thereafter.
PROJECTED ACCRUAL: A total of 200 patients will be accrued for this study.
- Conditions
- Bladder Cancer
- Being tested
- BCG vaccine, mitomycin C, radiation therapy
- Keywords
- stage I 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.
BCG vaccineBiological
mitomycin CDrug
radiation therapyRadiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startSep 1991
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
Sponsor and investigators
- Lead sponsor
- Medical Research Council
- Sponsor type
- Other government
- Investigators
- Stephen J. Harland, MD, Study chair, University College London Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002490
- Sponsor's protocol ID
- CDR0000077404
- Other IDs
- MRC-BS06, EU-91019, ISRCTN65282717
- Status last verified
- Jun 2001
- First submitted
- 1 Nov 1999
- Last updated
- 18 Dec 2013
- Results posted
- No
Publications
Harland SJ: A randomised trial of radical radiotherapy in pT1G3 NXM0 bladder cancer (MRC BS06). [Abstract] J Clin Oncol 23 (Suppl 16): A-4505, 379s, 2005.
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A RANDOMIZED TRIAL OF RADICAL RADIOTHERAPY IN pT1G3 NXM0 BLADDER CANCER
- ClinicalTrials.gov ID
- NCT00002490
- Acronym / sponsor ID
- CDR0000077404
- Conditions
- Bladder Cancer
- Keywords
- stage I bladder cancer, transitional cell carcinoma of the bladder
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Medical Research CouncilOther government
- Study start
- Sep 1991
- First posted
- 27 Jan 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with radiation therapy may kill more tumor cells. It is not known whether receiving either radiation therapy, chemotherapy, or observation is more effective for cancer of the bladder.
PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy, chemotherapy, or observation following tumor surgery in treating patients who have bladder cancer.
Detailed description
OBJECTIVES:
- Compare the efficacy of adjuvant radical radiotherapy vs intravesical BCG or mitomycin vs observation alone after endoscopic resection in terms of the progression rate and survival of patients with stage I, grade 3 transitional cell carcinoma of the bladder.
- Determine the toxicity of radical radiotherapy in these patients.
- Determine the incidence of carcinoma in situ elsewhere in the bladder and its correlation with the subsequent clinical outcome of these patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to center, extent of tumor (single tumor without carcinoma in situ (CIS) vs multiple tumors or CIS), and WHO performance status. Patients with a single tumor and no CIS are randomized to arm I or II. Patients with multiple tumors or CIS are randomized to arm II or III.
- Arm I: Patients undergo observation only.
- Arm II: Patients undergo radical radiotherapy 5 days a week for 6 weeks. Patients found to be node positive on CT scan may undergo pelvic irradiation and remain on study.
- Arm III: Patients receive intravesical BCG or mitomycin (at the discretion of the physician) weekly for 6-12 weeks.
Patients on arms I and III are followed at 3 months after randomization. All patients are followed at 6, 9, and 12 months and then annually thereafter.
PROJECTED ACCRUAL: A total of 200 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BCG vaccine | Biological | – |
| mitomycin C | Drug | – |
| radiation therapy | Radiation | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2013.
- Results publicationHarland SJ: A randomised trial of radical radiotherapy in pT1G3 NXM0 bladder cancer (MRC BS06). [Abstract] J Clin Oncol 23 (Suppl 16): A-4505, 379s, 2005.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen J. Harland, MD study chair
University College London Hospitals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing BCG vaccine, mitomycin C and radiation therapy in people with Bladder Cancer, run by Medical Research Council at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00002490, which also lists 1 linked publication.
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 18 Dec 2013.