Bladder CancerPhase 3NCT00042887
Chemotherapy With or Without Surgery in Treating Patients With Bladder Cancer
A Phase 3 study testing mitomycin C and conventional surgery in people with Bladder Cancer, run by European Organisation for Research and Treatment of Cancer - EORTC at 12 sites in 5 countries.
Trial summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Infusing chemotherapy drugs directly into the bladder may kill more cancer cells. Read more about this study
- Who is it for?
- Ages Up to 80 years
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- mitomycin C and conventional surgery
- Type of treatment
- Surgery or procedure
- How many people
- 58 participants
- Where
- 12 sitesin 5 countries
- Study dates
- May 2002to May 2004
- 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 Up to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
DISEASE CHARACTERISTICS:
- Cytologically confirmed solitary primary or recurrent papillary transitional cell carcinoma of the bladder
- Ta or T1
- Tumor no greater than 2 cm in diameter
- Negative urine cytology
- No suspicious lesions in bladder requiring biopsy
- No tumors in the prostatic urethra or upper urinary tract
- No prior history of T1 G3 tumors, muscle invasive tumors (T2 or greater), or carcinoma in situ
PATIENT CHARACTERISTICS:
Age
- 80 and under
Performance status
- WHO 0-1
Life expectancy
- Not specified
Hematopoietic
- Not specified
Hepatic
- Not specified
Renal
- Not specified
Other
- HIV negative
- No active intractable or uncontrollable bladder infection
- No urethral strictures that would preclude endoscopic procedures or repeated catheterization
- No prior or concurrent congenital or acquired immune deficiency syndrome
- No other prior or concurrent malignancy except cured basal cell skin cancer or intraepithelial cancer of the cervix
- No prior or concurrent leukemia or Hodgkin's disease
- No concurrent disease for which general anesthesia is contraindicated
- No psychological, familial, sociological, or geographical condition that would preclude study compliance
- Not pregnant or nursing
PRIOR CONCURRENT THERAPY:
Biologic therapy
- More than 12 months since prior BCG vaccine
Chemotherapy
- At least 1 year since prior mitomycin
Endocrine therapy
- Not specified
Radiotherapy
- No prior pelvic radiotherapy
Surgery
- No prior organ transplant
Other
- At least 3 months since prior intravesical treatment
Trial locations and contacts
12 sites in 5 countries.
12 sites in 5 countries
Belgium4 sites
Academisch Ziekenhuis der Vrije Universiteit Brussel
Brussels, 1090
Universitair Ziekenhuis Gent
Ghent, B-9000
Virga Jesse Hospital
Hasselt, 3500
U.Z. Gasthuisberg
Leuven, B-3000
Netherlands4 sites
Onze Lieve Vrouwe Gasthuis
Amsterdam, 1091 HA
Academisch Medisch Centrum
Amsterdam, 1105 AZ
Jeroen Bosch Ziekenhuis
NL'S Hertogenbosch, NL-5211
Daniel Den Hoed Cancer Center at Erasmus Medical Center
Rotterdam, 3008 AE
Italy2 sites
Universita Di Palermo
Palermo, 90141
Ospedale S.S. Annunziata
Savigliano, 12038
Turkey (Türkiye)1 site
Dokuz Eylul University School of Medicine
Izmir, 35340
About this study
Official title: Chemoresection With 4 Weekly Intravesical Instillations Of Mitomycin C Versus Transurethral Resection (TUR) Followed By One Single Immediate Instillation Of Mitomycin C In Single, Small, Papillary Stage Ta, T1 Bladder Tumors: A Prospective Randomized Phase III Trial
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Infusing chemotherapy drugs directly into the bladder may kill more cancer cells. It is not yet known if surgery followed by chemotherapy is more effective than chemotherapy alone in treating bladder cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of chemotherapy alone with that of transurethral resection followed by chemotherapy in treating patients who have bladder cancer.
Read the detailed description
OBJECTIVES:
- Compare the efficacy of chemoresection with 4 weekly intravesical instillations of mitomycin vs transurethral resection followed by 1 instillation of mitomycin in patients with low-risk superficial transitional cell carcinoma of the bladder.
- Compare the disease-free survival of patients treated with these regimens.
- Determine the response rate at 6 weeks in patients treated with chemoresection.
- Determine the percent of patients with tumor at 6 weeks treated with transurethral resection.
- Compare the quality of life of patients treated with these regimens.
- Compare the side effects of these regimens in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to disease status (primary vs recurrent) and participating center. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients undergo chemoresection with intravesical instillation of mitomycin once weekly for 4 weeks.
- Arm II: Patients undergo transurethral resection followed within 1-6 hours by intravesical instillation of mitomycin.
Quality of life is assessed at baseline, at week 1 (arm II only), at week 5 (arm I only), and then at week 6.
Patients are followed at weeks 6 and 19, every 6 months for 3 years, and then annually for 2 years.
PROJECTED ACCRUAL: A total of 1,000 patients (500 per treatment arm) will be accrued for this study within 5 years.
- Conditions
- Bladder Cancer
- Being tested
- mitomycin C, conventional surgery
- Keywords
- stage 0 bladder cancer, stage I bladder cancer, recurrent 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.
mitomycin CDrug
conventional surgeryProcedure or surgery
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 startMay 2002
- Primary completionMay 2004
Why it stopped: low accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- More trials run by European Organisation for Research and Treatment of Cancer - EORTCThe sponsor's other registered studies.
- 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
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Willem Oosterlinck, MD, PhD, Study chair, University Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00042887
- Sponsor's protocol ID
- EORTC-30004
- Other IDs
- EORTC-30004
- Status last verified
- Sep 2012
- First submitted
- 5 Aug 2002
- Last updated
- 24 Sep 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chemoresection With 4 Weekly Intravesical Instillations Of Mitomycin C Versus Transurethral Resection (TUR) Followed By One Single Immediate Instillation Of Mitomycin C In Single, Small, Papillary Stage Ta, T1 Bladder Tumors: A Prospective Randomized Phase III Trial
- ClinicalTrials.gov ID
- NCT00042887
- Acronym / sponsor ID
- EORTC-30004
- Conditions
- Bladder Cancer
- Keywords
- stage 0 bladder cancer, stage I bladder cancer, recurrent bladder cancer, transitional cell carcinoma of the bladder
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: low accrual
- Enrolment
- 58 participants (actual)
- Lead sponsor
- European Organisation for Research and Treatment of Cancer - EORTCResearch network
- Study start
- May 2002
- Primary completion
- May 2004 (actual)
- 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: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Infusing chemotherapy drugs directly into the bladder may kill more cancer cells. It is not yet known if surgery followed by chemotherapy is more effective than chemotherapy alone in treating bladder cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of chemotherapy alone with that of transurethral resection followed by chemotherapy in treating patients who have bladder cancer.
Detailed description
OBJECTIVES:
- Compare the efficacy of chemoresection with 4 weekly intravesical instillations of mitomycin vs transurethral resection followed by 1 instillation of mitomycin in patients with low-risk superficial transitional cell carcinoma of the bladder.
- Compare the disease-free survival of patients treated with these regimens.
- Determine the response rate at 6 weeks in patients treated with chemoresection.
- Determine the percent of patients with tumor at 6 weeks treated with transurethral resection.
- Compare the quality of life of patients treated with these regimens.
- Compare the side effects of these regimens in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to disease status (primary vs recurrent) and participating center. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients undergo chemoresection with intravesical instillation of mitomycin once weekly for 4 weeks.
- Arm II: Patients undergo transurethral resection followed within 1-6 hours by intravesical instillation of mitomycin.
Quality of life is assessed at baseline, at week 1 (arm II only), at week 5 (arm I only), and then at week 6.
Patients are followed at weeks 6 and 19, every 6 months for 3 years, and then annually for 2 years.
PROJECTED ACCRUAL: A total of 1,000 patients (500 per treatment arm) will be accrued for this study within 5 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
Who may qualify
- Ages
- Up to 80 years
- 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 |
|---|---|---|
| mitomycin C | Drug | – |
| conventional surgery | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early (reason given: low accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2012.
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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.
Willem Oosterlinck, MD, PhD study chair
University Ghent
12 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing mitomycin C and conventional surgery in people with Bladder Cancer, run by European Organisation for Research and Treatment of Cancer - EORTC at 12 sites in 5 countries.
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: stopped early, as of the sponsor's last update on 24 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Belgium, Netherlands, Italy, Slovakia, Turkey (Türkiye). 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 was stopped early (reason given: low accrual). Results are not available in the source record.
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?
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 24 Sep 2012.