Superficial Bladder Cancer: Selection of the Optimal Bladder Irrigation with a Chemotherapeutic Based on Personalized Primary Tumor Cultures
Résumé de l'étude
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)
Intervention étudiée
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)
Maladie en cours d'investigation
Superficial bladder cancer, well-differentiated and low-aggressive
(BASEC)
Superficial bladder cancer, well-differentiated and low-aggressive > 18 years First diagnosis (BASEC)
Critères d'exclusion
Previous injuries and scars of the urethra Aggressive bladder cancer Recurrent urinary tract infections Pregnancy and breastfeeding (BASEC)
Lieu de l’étude
Autre
(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)
Contact pour plus d'informations sur l'étude
Personne de contact en Suisse
Roland Seiler-Blarer
+41 32 324 32 06
Roland.Seiler-Blarer@clutterszb-chb.chKlinik für Urologie, Spitalzentrum Biel Vogelsang 84, 2501 Biel, Schweiz
(BASEC)
Informations générales
Department of Urology
+41 32 324 32 06+41 32 324 32 06
urologie@szb-chb.chr_seiler@gmx.ch(ICTRP)
Nom du comité d'éthique approbateur (pour les études multicentriques, uniquement le comité principal)
Commission cantonale d'éthique de Berne
(BASEC)
Date d'approbation du comité d'éthique
14.12.2022
(BASEC)
Identifiant de l'essai ICTRP
NCT05024734 (ICTRP)
Titre officiel (approuvé par le comité d'éthique)
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)
Titre académique
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)
Titre public
Guiding Instillation in Non Muscle-invasive Bladder Cancer Based on Drug Screens in Patient Derived Organoids (ICTRP)
Maladie en cours d'investigation
Bladder CancerNon-muscle Invasive (ICTRP)
Intervention étudiée
Drug: EpirubicinDrug: MitomycinDrug: GemcitabineDrug: Docetaxel (ICTRP)
Type d'essai
Interventional (ICTRP)
Plan de l'étude
Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)
Critères d'inclusion/exclusion
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)
non disponible
Critères d'évaluation principaux et secondaires
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)
Date d'enregistrement
non disponible
Inclusion du premier participant
non disponible
Sponsors secondaires
University of Bern;Hospital Centre Biel/Bienne (ICTRP)
Contacts supplémentaires
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)
ID secondaires
SZB-URO-21-001 (ICTRP)
Résultats-Données individuelles des participants
non disponible
Informations complémentaires sur l'essai
https://clinicaltrials.gov/ct2/show/NCT05024734 (ICTRP)
Résultats de l'essai
Résumé des résultats
non disponible
Lien vers les résultats dans le registre primaire
non disponible