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40 mg MMC gel · OPTIMA

Pre-TURBT TC-3 Gel Intravesical Instillation in NMIBC

Ensayo de UroGen Pharma Ltd. en Carcinoma of Urinary Bladder, Superficial (del registro, en inglés).

Fase

Sin fase asignada

Estado

Completado

Participantes

80

previstos

Centros

13

Fin del objetivo primario

jul 2016

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, abierto. Comenzó en jun 2013.

Qué mide

ablative effect of pre-TURBT intravesical instillations of the treatments on The bladder lesion(s) of NMIBC patients (del registro, en inglés) (2 años)

Cómo lo describe el promotor

En el documentoEn inglés, del registroIn the proposed study the investigators aim to evaluate the effect of the standard of care dose (40mg) of MMC mixed with TC-3 gel (with sustained release mechanism on the drug) on low risk recurrent NMIBC lesions and to compare our findings to instillation with the standard mode of instillation- 40mg MMC in water in order to examine our hypothesis that MMC mixed with TC-3 gel will have at least non-inferior and even superior results over the standard instillation mode The investigators believe that this study is of importance of several aspects: 1. It evaluates a new mode of bladder instillation that may bypass the drawbacks of the current instillation mode. 2. If proved effective this mode of treatment might save the need of TURBT performance and serve as a new mode of tumor ablation. 3. Even if proved partially effective this mode of treatment will diminish tumors size or number thus enable a more limited TURBT procedure. 4. This mode of treatment will enable immediate medical attendance to the patient's tumor recurrence without the waiting period (resulting from queues in the medical centers) for TURBT, which might improve the patient's prognostic outcome. 5. If this experimental treatment will prove to have a better ablative effect, this could be translated to a better prophylactic effect of tumor recurrence.

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Ficha completa en ClinicalTrials.gov (NCT01803295), actualizada en jun 2017.