Low Grade Upper Tract Urothelial Cancer
Conditions
Brief summary
The primary efficacy outcome is the absence of UTUC tumors in the entire ipsilateral calyces, renal pelvis and ureter on endoscopic evaluation. This outcome will be determined dichotomously as either failure or success in achieving complete response., Complete Response will be defined as absence of disease based on: •absence of visual tumor on endoscopy •no evidence of tumor on biopsy (if feasible) •negative urinary cytology by instrumented collection, Additional information are part of the protocol (section Primary Endpoint/Estimand)
Detailed description
The duration of response at the entire ipsilateral kidney will be defined as absence of disease in the entire ipsilateral calyces, renal pelvis and ureter, The duration of response at the Treatment Area of the ipsilateral kidney will be defined as absence of disease in the ipsilateral Treatment Area, Overall renal functional outcome, Kidney organ loss or preservation, Pathological evaluation of response performed in kidney tissue of patient that will undergo kidney surgical removal following at least one TOOKAD (padeliporfin) VTP treatment, Safety follow up based and recording of adverse events, Additional information are part of the protocol (section Secondary Endpoint/Estimand)
Interventions
DRUGPADELIPORFIN
DRUGTOOKAD 183 mg powder for solution for injection
Sponsors
Steba Biotech S.A.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary efficacy outcome is the absence of UTUC tumors in the entire ipsilateral calyces, renal pelvis and ureter on endoscopic evaluation. This outcome will be determined dichotomously as either failure or success in achieving complete response., Complete Response will be defined as absence of disease based on: •absence of visual tumor on endoscopy •no evidence of tumor on biopsy (if feasible) •negative urinary cytology by instrumented collection, Additional information are part of the protocol (section Primary Endpoint/Estimand) | — |
Secondary
| Measure | Time frame |
|---|---|
| The duration of response at the entire ipsilateral kidney will be defined as absence of disease in the entire ipsilateral calyces, renal pelvis and ureter, The duration of response at the Treatment Area of the ipsilateral kidney will be defined as absence of disease in the ipsilateral Treatment Area, Overall renal functional outcome, Kidney organ loss or preservation, Pathological evaluation of response performed in kidney tissue of patient that will undergo kidney surgical removal following at least one TOOKAD (padeliporfin) VTP treatment, Safety follow up based and recording of adverse events, Additional information are part of the protocol (section Secondary Endpoint/Estimand) | — |
Countries
Austria, France, Germany, Italy, Spain
Outcome results
None listed