An interventional study of Mitomycin/Gemcitabine and Saline in UTUC, sponsored by Carmel Medical Center. Recruiting at 10 sites in Israel. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-12-20.
Sponsored by Carmel Medical Center · Not applicable, Interventional, and Treatment
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.
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.
Carmel Medical Center is the lead sponsor of 119 studies on the registry; 7 are open to participants now.
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No recurrence within the last two years Are not on active bladder irrigation protocol
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Single post-operative MMC 40mg or gemcitabine 2gr in Saline 0.9% 50cc bladder instillation
Drug: Mitomycin/Gemcitabine
Single post-operative 50cc Saline 0.9% bladder instillation
Drug: Saline
Drug pages: Mitomycin · Gemcitabine
UTUC treatment
UTUC treatment
1 year IVR free survival
no intravesical recurrence of Upper Tract Urothelial Carcinoma in a patient for 1 year
Time frame: 1 year
2 years IVR free survival
no intravesical recurrence of Upper Tract Urothelial Carcinoma in a patient for second year
Time frame: 2 years
Disease free survival
Time frame: 2 years
High grade (>3) adverse events
Adverse events that are severe or medically significant but not immediately life threatening
Time frame: 2 years
Plan to share: No
No publications or documents are linked to this record.
Started Apr 2023 (actual). Primary completion is estimated for Jan 2028, 57 months after the start.
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Studies of the drugs tested here: Mitomycin · Gemcitabine