Bladder Cancer Clinical Trial
— BCG/EMDA-MMCOfficial title:
Sequential Bacillus Calmette-Guérin and Electromotive Mitomycin-C Versus Bacillus Calmette-Guérin Alone for High Risk Superficial Bladder Cancer: a Prospective Randomised Study
Verified date | September 2011 |
Source | University of Rome Tor Vergata |
Contact | n/a |
Is FDA regulated | No |
Health authority | Italy: Ethics Committee |
Study type | Interventional |
Intravesical treatment for superficial bladder cancer has been used for the past 4-5
decades. Intravesical chemotherapy is beneficial in terms of recurrence and time to
recurrence in grade 1-2 stage Ta tumours, usually non-invasive. Intravesical chemotherapy
has negligible effect on disease progression in high-risk superficial bladder cancer—ie,
grade 3, stage T1, and carcinoma in situ. However, BCG as induction and maintenance
treatment effectively delays progression. Electromotive mitomycin increases tissue uptake
compared with that of passive diffusion. Electromotive mitomycin has emerged as an
alternative or complementary treatment to BCG. The rationale for combining anticancer drugs
is based on the need to increase efficacy and reduce emergence of resistant malignant cells.
This approach is not frequently applied to use of intravesical agents for treatment of
superficial bladder cancer, for which immunotherapeutic BCG and chemotherapeutic mitomycin
seem to be a potentially effective combination. Studies have addressed concurrent use of
mitomycin and BCG, and assigned two roles to mitomycin: antitumor action and
tissue-scarifying (ie, surface-modifying) effect that enables BCG to attach more efficiently
to the urothelium. The investigators therefore aimed to assess whether induction of
inflammation by use of BCG before mitomycin treatment makes the bladder mucosa more
permeable and thus enables mitomycin to reach the target more easily. This randomised trial
to compare the efficacy of sequential BCG and electromotive mitomycin with that of the
current standard of BCG alone for patients with high-risk superficial bladder cancer.
After transurethral resection and multiple biopsies patients with stage pT1 bladder cancer
are randomly assigned to: 81 mg BCG infused over 120 min once a week for 6 weeks; or to 81
mg BCG infused over 120 min once a week for 2 weeks, followed by 40 mg electromotive
mitomycin (intravesical electric current 20 mA for 30 min) once a week as one cycle for
three cycles (n=107). Complete responders underwent maintenance treatment: those assigned
BCG alone had one infusion of 81 mg BCG once a month for 10 months, and those assigned BCG
and mitomycin had 40 mg electromotive mitomycin once a month for 2 months, followed by 81 mg
BCG once a month as one cycle for three cycles. The primary endpoint was disease-free
interval; secondary endpoints were time to progression; overall survival; and
disease-specific survival. Analyses were intention to treat.
Status | Completed |
Enrollment | 212 |
Est. completion date | June 2002 |
Est. primary completion date | June 2002 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 90 Years |
Eligibility |
Inclusion Criteria: - adequate bone-marrow reserve (ie, white-blood-cell count =4000 x106 cells/L and platelet count =120 x 109/L) - normal renal function (ie, serum creatinine =123•76 µmol/L) - normal liver function (ie, serum glutamic-oxaloacetic transaminase =42 U/L, serum glutamic-pyruvic transaminase =48 U/L, and total bilirubin =22•23 µmol/L) - Karnofsky performance status between 50 and 100. Exclusion Criteria: - previous treatment with BCG or electromotive mitomycin - treatment with any other intravesical cytostatic agent within the past 6 months - concomitant urothelial tumours of the upper urinary tract; - previous muscle-invasive (ie, stage T2 or higher) transitional-cell - carcinoma of the bladder - bladder capacity less than 2 L - untreated urinary-tract infection - severe systemic infection (ie, sepsis) - urethral strictures that would prevent endoscopic procedures and repeated catheterisation - disease of upper urinary tract (eg, vesicoureteral reflux or urinary-tract stones) that would make multiple transurethral procedures a risk - previous radiotherapy to the pelvis - other concurrent chemotherapy - treatment with radiotherapy-response or biological-response modifiers; - history of tuberculosis - other malignant diseases within 5 years of trial registration (except for basal-cell carcinoma) - pregnancy or nursing - psychological, familial, sociological, or geographical factors that would preclude study participation. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Italy | Dept. of Surgery/Urology, Tor Vergata University | Rome | RM |
Lead Sponsor | Collaborator |
---|---|
University of Rome Tor Vergata | University of L'Aquila |
Italy,
Di Stasi SM, Giannantoni A, Giurioli A, Valenti M, Zampa G, Storti L, Attisani F, De Carolis A, Capelli G, Vespasiani G, Stephen RL. Sequential BCG and electromotive mitomycin versus BCG alone for high-risk superficial bladder cancer: a randomised control — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Disease-free interval | The primary endpoint is disease-free interval for patients without carcinoma in situ and for patients with carcinoma in situ who are disease-free after treatment—ie, time from randomisation to first cystoscopy noting recurrence. Patients with carcinoma in situ who did not have complete response after 3 months of treatment are regarded as having recurrence with no follow-up. | From date of randomization until the date of first documented recurrence, assessed up to 120 months | Yes |
Secondary | Time to progression | Time to progression is defined as time from randomisation until the onset of muscle-invasive disease as recorded by pathological assessment of transurethral-resection samples or biopsy samples. Patients without recurrence or progression are censored at the last cystoscopy, and those lost to follow-up are censored at the last known day of survival. | From date of randomization until the date of documented progression, assessed up to 120 months. | Yes |
Secondary | Overall survival | Overall survival is defined as time from randomisation until death from any cause. Patients without recurrence or progression are censored at the last cystoscopy, and those lost to follow-up are censored at the last known day of survival. | From date of randomization until the date of death for any cause, assessed up to 120 months. | Yes |
Secondary | Disease-specific survival | Disease-specific survival as time from randomisation until death from bladder cancer. Patients without recurrence or progression are censored at the last cystoscopy, and those lost to follow-up are censored at the last known day of survival. | From date of randomization until the date of death for bladder cancer, assessed up to 120 months. | Yes |
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