POST URS Chemotherapy Instillation
- Conditions
- UTUC
- Interventions
- Drug: Mitomycin/GemcitabineDrug: Saline
- Registration Number
- NCT06167057
- Lead Sponsor
- Carmel Medical Center
- Brief Summary
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.
- Detailed Description
URS is routinely used for both diagnosis and treatment of UTUC - it is used either as an initial diagnostic procedure or as a curative procedure in cases amenable for endoscopic tumor ablation; either with low-risk disease or an imperative indication due to impaired renal function.
Following extirpative surgery patients are prone to IVR. Those patients undergo routine follow-up with cystoscopy and in cases of IVR require TURBT and further management based on bladder cancer protocols. In this setting, a single post-operative bladder instillation with various chemotherapeutic agents has shown a significant reduction in IVR rates following RNU.
Retrospective evidence suggests there is an increase IVR rates following URS for UTUC.
In this study the investigators seek to evaluate the efficacy of a single, post URS, bladder instillation with chemotherapy to reduce IVR.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 264
- Radiographic and/or cytological suspicion for UTUC
- Planned endoscopic procedure for treatment / diagnosis of UTUC
- Patients with bladder cancer history are eligible if meeting both following criteria:
No recurrence within the last two years Are not on active bladder irrigation protocol
- Patients with history of UTUC are eligible if last endoscopic treatment or RNU was >1 year prior to enrollment
- Age โฅ 18 years
- Performance status ECOG 0-2
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description A Mitomycin/Gemcitabine Single post-operative MMC 40mg or gemcitabine 2gr in Saline 0.9% 50cc bladder instillation B Saline Single post-operative 50cc Saline 0.9% bladder instillation
- Primary Outcome Measures
Name Time Method 1 year IVR free survival 1 year no intravesical recurrence of Upper Tract Urothelial Carcinoma in a patient for 1 year
- Secondary Outcome Measures
Name Time Method 2 years IVR free survival 2 years no intravesical recurrence of Upper Tract Urothelial Carcinoma in a patient for second year
Disease free survival 2 years High grade (>3) adverse events 2 years Adverse events that are severe or medically significant but not immediately life threatening
Trial Locations
- Locations (10)
Tel Aviv Sourasky Medical Center - Ichilov
๐ฎ๐ฑTel Aviv, Israel
Bnai Zion Medical Center
๐ฎ๐ฑHaifa, Israel
Carmel Medical Center
๐ฎ๐ฑHaifa, Israel
Soroka University Medical Center
๐ฎ๐ฑBe'er Sheva, Israel
Kaplan Medical Center
๐ฎ๐ฑReแบovot, Israel
Rabin Medical Center - Beilinson and Hasharon
๐ฎ๐ฑPetah Tikva, Israel
Ziv Medical Center
๐ฎ๐ฑZefat, Israel
Assuta Ashdod Hospital
๐ฎ๐ฑAshdod, Israel
Shamir Medical Center
๐ฎ๐ฑBe'er Ya'aqov, Israel
Rambam Health Care Campus
๐ฎ๐ฑHaifa, Israel