Superficial Bladder Cancer: Selection of the Optimal Bladder Irrigation with a Chemotherapeutic Based on Personalized Primary Tumor Cultures
Zusammenfassung der Studie
In patients with superficial bladder cancer, tumor samples are cultured and the efficacy of 4 different chemotherapeutics is tested on these personalized cultures. The drug that shows the highest efficacy in the tumor model is selected. The bladder is then irrigated on an outpatient basis 6 times at weekly intervals with the drug after surgery to prevent recurrence.
(BASEC)
Untersuchte Intervention
The four drugs are already in clinical use for this condition, they show different efficacy and are currently used according to the urologist's preference and availability in the hospital. We wanted to test whether we could use primary cultures from superficial bladder cancer to test these chemotherapeutics. The information obtained should then help in the clinic to make a personalized decision regarding the choice of the appropriate drug.
(BASEC)
Untersuchte Krankheit(en)
Superficial bladder cancer, well-differentiated and low-aggressive
(BASEC)
Superficial bladder cancer, well-differentiated and low-aggressive > 18 years First diagnosis (BASEC)
Ausschlusskriterien
Previous injuries and scars of the urethra Aggressive bladder cancer Recurrent urinary tract infections Pregnancy and breastfeeding (BASEC)
Studienstandort
Andere
(BASEC)
Klinik für Urologie Spitalzentrum Biel
(BASEC)
Sponsor
Spitalzentrum Biel, 2501 Biel, Switzerland Represented by: Prof. Dr. med. Roland Seiler-Blarer, Chairman Klinik für Urologie, Spitalzentrum Biel Vogelsang 84, 2501 Biel, Schweiz
(BASEC)
Kontakt für weitere Auskünfte zur Studie
Kontaktperson Schweiz
Roland Seiler-Blarer
+41 32 324 32 06
Roland.Seiler-Blarer@clutterszb-chb.chKlinik für Urologie, Spitalzentrum Biel Vogelsang 84, 2501 Biel, Schweiz
(BASEC)
Allgemeine Auskünfte
Department of Urology
+41 32 324 32 06+41 32 324 32 06
urologie@szb-chb.chr_seiler@gmx.ch(ICTRP)
Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Ethikkommission Bern
(BASEC)
Datum der Bewilligung durch die Ethikkommission
14.12.2022
(BASEC)
ICTRP Studien-ID
NCT05024734 (ICTRP)
Offizieller Titel (Genehmigt von der Ethikkommission)
Guidance of adjuvant instillation in intermediate risk non-muscle invasive bladder cancer by drug screens in patient derived organoids. A Single center, Open-label, Phase II trial with a feasibility endpoint. (BASEC)
Wissenschaftlicher Titel
Guidance of Adjuvant Instillation in Intermediate Risk Non-muscle Invasive Bladder Cancer by Drug Screens in Patient Derived Organoids. a Single Center, Open-label, Phase II Trial with a Feasibility Endpoint. (GAIN-INST-TRIAL) (ICTRP)
Öffentlicher Titel
Guiding Instillation in Non Muscle-invasive Bladder Cancer Based on Drug Screens in Patient Derived Organoids (ICTRP)
Untersuchte Krankheit(en)
Bladder CancerNon-muscle Invasive (ICTRP)
Untersuchte Intervention
Drug: EpirubicinDrug: MitomycinDrug: GemcitabineDrug: Docetaxel (ICTRP)
Studientyp
Interventional (ICTRP)
Studiendesign
Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)
Ein-/Ausschlusskriterien
Inclusion Criteria:
- Age = 18 years
- Signed Informed Consent Form
- ECOG performance status of 0 or 1
- Histologically confirmed intermediate risk non muscle-invasive urothelial carcinoma
of the bladder (pTa low grade) Patients
- Representative fresh tumor specimen for PDO generation and drug screen
Exclusion Criteria:
- Known previous high grade and/or high risk non muscle-invasive bladder cancer
- Previous Intravesical biological/immuno (BCG) therapy
- Pregnancy or nursing
- Evidence of significant uncontrolled concomitant disease that could affect
compliance with the protocol
- Severe infection within 4 weeks prior to cycle 1, day 1
- Contraindication for frequent catheterization
- Voiding dysfunction
- Pregnancy or nursing
- Female subject of childbearing potential who is unwilling to use acceptable
method(s) of effective contraception during study treatment and through 6 months
after the last treatment.
- Male subject who is unwilling to use acceptable method of effective contraception
during IP treatment and through 6 months after the last dose of IP. (ICTRP)
nicht verfügbar
Primäre und sekundäre Endpunkte
Proportion of patients with successful drug selection (ICTRP)
Proportion of patients for whom patient-derived organoids (PDOs) can be successfully generated (regardless of subsequent drug screen);Rate of recurrence in the study population;Recurrence free survival 24 months after TURBT;Progression free survival 24 months after TURBT;General quality of Life;Quality of Life related to the bladder cancer;Safety profile of instillations (ICTRP)
Registrierungsdatum
nicht verfügbar
Einschluss des ersten Teilnehmers
nicht verfügbar
Sekundäre Sponsoren
University of Bern;Hospital Centre Biel/Bienne (ICTRP)
Weitere Kontakte
Roland Seiler-Blarer, MDRoland Seiler-Blarer, MDRoland Seiler-Blarer, Prof., urologie@szb-chb.chr_seiler@gmx.ch, +41 32 324 32 06+41 32 324 32 06, Department of Urology (ICTRP)
Sekundäre IDs
SZB-URO-21-001 (ICTRP)
Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
nicht verfügbar
Weitere Informationen zur Studie
https://clinicaltrials.gov/ct2/show/NCT05024734 (ICTRP)
Ergebnisse der Studie
Zusammenfassung der Ergebnisse
nicht verfügbar
Link zu den Ergebnissen im Primärregister
nicht verfügbar