Health TrialsbyHealthPanel

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Mitomycin/Gemcitabine

    Drug

    UTUC treatment

  • Saline

    Drug

    UTUC treatment

Treatment groups

264 Participants
are divided into 2 treatment groups
Group A: AExperimental treatment 1 intervention
Group B: BPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

1 year IVR free survival

no intravesical recurrence of Upper Tract Urothelial Carcinoma in a patient for 1 year

Time frame
1 year

Secondary outcomes

1

2 years IVR free survival

no intravesical recurrence of Upper Tract Urothelial Carcinoma in a patient for second year

Time frame
2 years
2

Disease free survival

Time frame
2 years
3

High grade (>3) adverse events

Adverse events that are severe or medically significant but not immediately life threatening

Time frame
2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Carmel Medical Center

Lead sponsor

Source ClinicalTrials.gov
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