Sequential Combination Therapy in Bladder Cancer (MITOBCG)
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|ClinicalTrials.gov Identifier: NCT03790384|
Recruitment Status : Unknown
Verified December 2018 by Azienda Ospedaliera "Sant'Andrea".
Recruitment status was: Not yet recruiting
First Posted : December 31, 2018
Last Update Posted : December 31, 2018
|Condition or disease||Intervention/treatment||Phase|
|Bladder Cancer||Drug: Mitomycin||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||140 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||The subjects will be assessed for eligibility at the screening visit (Visit 1) three weeks after TURB and re-TURB prior to randomization and only subjects who fulfil the inclusion criteria will be included: patients with a diagnosis of High risk NMIBC: T1 tumor, G3, CIS, or multiple and recurrent and large (>3 cm) Ta or patients in the last EAU recurrence category (EAU/EORTC recurrence score >/=10). Patients selected for the study, are centrally randomized (randomization is performed at the Sant'Andrea Hospital) to receive BCG induction treatment according to the standard protocol (an instillation once a week for six weeks) with ImmuCyst (81 mg Connaught strain BCG). Patients in group two received BCG treatment with the same protocol with a 40 mg mitomycin instillation the day before .|
|Official Title:||The Effects of Sequential Mitomycin and Bacillus Calmette-Guérin Treatment Versus Bacillus Calmette-Guérin Monotherapy in Patients With High Risk Non-Muscle Invasive Bladder Cancer|
|Estimated Study Start Date :||January 15, 2019|
|Estimated Primary Completion Date :||September 15, 2019|
|Estimated Study Completion Date :||January 15, 2021|
No Intervention: Bacillus Calmette-Guérin
Patients receive Bacillus Calmette-Guérin induction treatment according to the standard protocol (an instillation once a week for six weeks) with ImmuCyst (81 mg Connaught strain BCG).
Experimental: Mytomicin and Bacillus Calmette-Guérin
Patients received BCG treatment with the same protocol. Intervention will be a 40 mg mitomycin instillation the day before every single BCG instillation
Patients receive BCG induction treatment according to the standard protocol (an instillation once a week for six weeks) with ImmuCyst (81 mg Connaught strain BCG) with a 40 mg mitomycin instillation the day before .
Other Name: Bacillus Calmette-Guerin
- Recurrence rate [ Time Frame: 2 years ]To evaluate the effect in term of recurrence rate of sequential combination therapy of Mitomycin and Bacillus Calmette-Guérin versus Bacillus Calmette-Guérin monotherapy in patients with High grade Non-Muscle Invasive Bladder Cancer.through cystoscopy every three months and Uro Tomography Computerized yearly
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: 2 years ]To evaluate the overall toxicity of sequential combination therapy of Mitomycin and Bacillus Calmette-Guérin versus Bacillus Calmette-Guérin monotherapy through CTCAE v4.0. Patients have to fill in International Prostate Symptoms Score, NIH-CPSI, PUF questionaries. Every three months patients will be visited and have a cystoscopy. We will hear about self-reported symptoms and we will measure body temperature
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03790384
|Contact: Andrea Tubarofirstname.lastname@example.org|
|Principal Investigator:||Andrea Tubaro||Azienda Ospedaliera "Sant'Andrea"|