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Bladder CancerPhase 3NCT00867347

Radiation Therapy or Surgery in Treating Patients Receiving Chemotherapy for Bladder Cancer

A Phase 3 study testing therapeutic conventional surgery and radiation therapy in people with Bladder Cancer, run by Institute of Cancer Research, United Kingdom at 1 site 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: Drugs used in chemotherapy, such as gemcitabine and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Read more about this study

Who is it for?
Ages 18 to 120 years
Conditions the study is for
Bladder Cancer
What is being tested?
therapeutic conventional surgery and radiation therapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
45 participants
Where
1 siteUnited Kingdom
Study dates
Jul 2007to Apr 2017
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 to 120 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS:

  • Histologically confirmed transitional cell carcinoma (TCC) of the bladder
  • Clinical stage T2-T3, N0, M0
  • No widespread carcinoma in situ (CIS) or CIS remote from muscle invasive tumor
  • No adenocarcinoma, squamous cell carcinoma (SCC), small cell carcinoma, or other variant histology
  • N.B. squamoid differentiation or mixed TCC/SCC allowed
  • No simultaneous upper tract, urethral, or prostatic urethral TCC
  • Direct prostatic urethral extension from bladder primary allowed if not involving prostatic stroma
  • Currently receiving 3 courses of gemcitabine hydrochloride-cisplatin or other protocol approved neoadjuvant chemotherapy regimen AND willing and fit to receive a 4th course according to study protocol

PATIENT CHARACTERISTICS:

  • WHO performance status 0-1
  • Hemoglobin > 10 g/dL
  • WBC > 3,000/mm³
  • Platelet count > 150,000/mm³
  • Bilirubin < 1.5 times upper limit of normal (ULN)
  • AST < 1.5 times ULN
  • Alkaline phosphatase < 1.5 times ULN
  • Not pregnant
  • Fit for radical cystectomy or radical radiotherapy
  • No prior malignancy within the past 5 years except superficial TCC or CIS
  • No untreated hydronephrosis
  • Patients with hydronephrosis are eligible if the kidney/ureter has been stented or nephrostomy has been inserted and renal function has been maintained
  • No contraindication to radical radiotherapy (e.g., inflammatory bowel disease, radiosensitivity syndrome, or severe diverticular disease)
  • No bilateral total hip replacements
  • No significant comorbid medical conditions that would interfere with administration of any protocol treatment

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No prior pelvic radiotherapy

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • Institute of Cancer Research - Sutton

    Sutton, England, SM2 5PT

Other trials in United Kingdom

About this study

Official title: Randomised Trial of Selective Bladder Preservation Against Radical Excision (Cystectomy) in Muscle Invasive T2/T3 Transitional Cell Carcinoma of the Bladder - Feasibility Study

RATIONALE: Drugs used in chemotherapy, such as gemcitabine and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Radiation therapy uses high-energy x-rays to kill tumor cells. It is not yet known whether radiation therapy is more effective than surgery in treating patients with bladder cancer.

PURPOSE: This randomized phase III trial is studying radiation therapy to see how well it works compared with surgery in treating patients with bladder cancer who are receiving chemotherapy.

Read the detailed description

OBJECTIVES:

Primary

  • To determine the feasibility and patient acceptability of radical cystectomy vs selective bladder preservation (SBP) after neoadjuvant chemotherapy in patients with muscle-invasive transitional cell carcinoma of the bladder.
  • To determine compliance rates of patients with their assigned treatments.
  • To determine if bladder preservation is equivalent to radical cystectomy, in terms of overall survival, in responders to neoadjuvant chemotherapy.

Secondary

  • To compare the overall survival of patients receiving SBP vs radical cystectomy.
  • To determine the rate of salvage cystectomy in patients undergoing bladder preservation.
  • To determine and compare the toxicity of treatment in both arms.
  • To determine and compare quality of life of patients treated with these regimens.
  • To compare locoregional progression-free and metastasis-free survival of patients treated with these regimens.

OUTLINE: This is a multicenter study. Patients are stratified according to cancer center and randomized to 1 of 2 treatment arms. Patients are assessed after completion of 3 courses of pre-study neoadjuvant chemotherapy. Patients with poor response (≥ pT2, residual pT2, macroscopic invasive tumor) undergo immediate radical cystectomy (within 6 weeks fo completing chemotherapy). Patients* with responsive disease (≤ pT1 tumor or macroscopically normal bladder) proceed to course 4 of chemotherapy (on-study) followed by treatment according to randomization arm.

NOTE: *Patients with a clear bladder or those who are unsure of their histological results prior to course 4 also proceed to chemotherapy.

  • Course 4 of neoadjuvant chemotherapy: Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and cisplatin IV over 4 hours on day 1.
  • Arm I (radical cystectomy): Patients undergo a radical cystectomy, including pelvic lymphadenectomy, between 4 and 6 weeks after initiating course 4 of chemotherapy.
  • Arm II (selective bladder preservation): Patients with no visible residual tumor (cT0 or pT0) or residual but superficial tumor (pTa, pT1) undergo radiotherapy beginning within 4-6 weeks of day 1 of course 4 and continuing for 6.5 weeks.

Health-related quality of life is assessed periodically.

After completion of study treatment, patients are followed periodically for up to 5 years.

Conditions
Bladder Cancer
Being tested
therapeutic conventional surgery, radiation therapy
Keywords
transitional cell carcinoma of the bladder, stage II bladder cancer, stage III bladder cancer
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.

Study groups in NCT00867347
Study groupRoleWhat they receive
Arm IActive comparatorPatients undergo a radical cystectomy, including pelvic lymphadenectomy, between 4 and 6 weeks after initiating course 4 of chemotherapy.
Receives: Procedure: therapeutic conventional surgery
Arm IIExperimentalPatients with no visible residual tumor (cT0 or pT0) or residual but superficial tumor (pTa, pT1) undergo radiotherapy beginning within 4-6 weeks of day 1 of course 4 and continuing for 6.5 weeks.
Receives: Radiation: radiation therapy

What is being measured

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

  1. Number of patients randomized over 3 years

  2. Proportion of patients undergoing selective bladder preservation

  3. Proportion of patients undergoing radical cystectomy

  4. Overall survival

Secondary outcomes (5)

  1. Compliance with randomized treatment

  2. Rate of salvage cystectomy after selective bladder preservation

  3. Toxicity as assessed by NCI CTCAE v3.0

  4. Quality of life as assessed by the QLQ-C30 v3.0 questionnaire

  5. Locoregional progression-free, metastasis-free, and overall survival

Timeline

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

  1. First posted23 Mar 2009 (estimated)
  2. Study startJul 2007
  3. Primary completionFeb 2010
  4. Study completionApr 2017

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
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
45 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00867347
Sponsor's protocol ID
CDR0000633526
Other IDs
ICR-SPARE, ISRCTN61126465, EU-20907, ICR-CTSU/2006/10002
Status last verified
Jan 2019
First submitted
20 Mar 2009
Last updated
4 Jan 2019
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Paramasivan S, Huddart R, Hall E, Lewis R, Birtle A, Donovan JL. Key issues in recruitment to randomised controlled trials with very different interventions: a qualitative investigation of recruitment to the SPARE trial (CRUK/07/011). Trials. 2011 Mar 15;12:78. doi: 10.1186/1745-6215-12-78.

    PubMed 21406089

  • Huddart RA, Birtle A, Maynard L, Beresford M, Blazeby J, Donovan J, Kelly JD, Kirkbank T, McLaren DB, Mead G, Moynihan C, Persad R, Scrase C, Lewis R, Hall E. Clinical and patient-reported outcomes of SPARE - a randomised feasibility study of selective bladder preservation versus radical cystectomy. BJU Int. 2017 Nov;120(5):639-650. doi: 10.1111/bju.13900. Epub 2017 May 29.

    PubMed 28453896

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing therapeutic conventional surgery and radiation therapy in people with Bladder Cancer, run by Institute of Cancer Research, United Kingdom at 1 site 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 4 Jan 2019. 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.

What does the primary outcome measure?

Number of patients randomized over 3 years. The study lists 4 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 NCT00867347, 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 4 Jan 2019.

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