POST URS Chemotherapy Instillation
ConditionUTUC
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCarmel Medical Center
About this trial
The goal of this study is to evaluate the safety and oncological outcomes of single chemotherapy bladder instillation following endoscopic treatment for UTUC in UTUC suspected patients .The main aim is to determine the efficacy of a single, post URS, chemotherapy bladder instillation to reduce IVR.
Participants will be given single chemotherapy bladder instillation within 24h following ureteroscopy and will follow routine follow-up for IVR which will include white light cystoscopy ;patients with suspected IVR (based on either imaging or cystoscopy) will undergo TURBT.
Eligibility criteria
Qualifiers
Radiographic and/or cytological suspicion for UTUC
Planned endoscopic procedure for treatment / diagnosis of UTUC
Patients with history of UTUC are eligible if last endoscopic treatment or RNU was >1 year prior to enrollment
Age ≥ 18 years
Disqualifiers
Subjects who have had bladder / prostate radiotherapy
Subjects with bladder cancer history on active bladder irrigation protocols or with active disease within two years prior to enrollment
Subjects with previously treated UTUC within one year prior to enrollment
Subjects with metastatic disease
Trial design
Treatments tested in this trial
- Mitomycin/Gemcitabine
- Saline
Treatment groups
264 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov