CISTO: Comparison of Intravesical Therapy and Surgery as Treatment Options for Bladder Cancer (NCT03933826) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
CISTO: Comparison of Intravesical Therapy and Surgery as Treatment Options for Bladder Cancer
United States570 participantsStarted 2019-07-09
Plain-language summary
Bladder cancer is the most common urinary tract cancer and the 5th most common cancer in the US (1). Yet bladder cancer research is underfunded relative to other common cancers. As a result, bladder cancer care is prone to evidence gaps that produce decision uncertainty for both patients and clinicians. The Comparison of Intravesical Therapy and Surgery as Treatment Options (CISTO) for Bladder Cancer Study has the potential to fill these critical evidence gaps, change care pathways for the management of non-muscle-invasive bladder cancer (NMIBC), and provide for personalized, patient-centered care. The purpose of CISTO is to conduct a large prospective study that directly compares the impact of medical management versus bladder removal in recurrent high-grade NMIBC patients with Bacillus Calmette-Guerin (BCG) failure on clinical outcomes and patient and caregiver experience using standardized patient-reported outcomes (PROs).
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Adult 18 years of age or older; and
✓. Presenting with high-grade NMIBC established by anatomic pathology as tumor stage classification Tis, Ta, or T1, and with:
✓. Pathology documentation from any hospital/clinic/medical center, and
✓. More than 50% urothelial carcinoma component in the specimen
✓. History of high-grade NMIBC established by anatomic pathology as tumor stage classification Tis, Ta, or T1; and
✓. Attempted or received induction BCG (at least 3 out of 6 instillations) at any point in time; and
✓. In the previous 12 months, received at least one instillation of any intravesical agent (induction or maintenance) or one administration of systemic therapy for NMIBC treatment.
Exclusion criteria
✕. Any plasmacytoid or small cell (neuroendocrine) component in the pathology (past or current presentation);
✕. Previous history of cystectomy or radiation therapy for bladder cancer;
What they're measuring
1
Patient-reported Quality of Life as Measured by the Physical Function Scale of the European Organization for Research and Treatment of Cancer Quality-of-Life-Questionnaire-Core-30 (EORTC QLQ-C30)
Timeframe: 12 months after enrollment
2
Patient-reported Quality of Life as Measured by the Physical Function Scale of the European Organization for Research and Treatment of Cancer Quality-of-Life-Questionnaire-Core-30 (EORTC QLQ-C30)
Timeframe: 24 months after enrollment
3
Patient-reported Quality of Life as Measured by the Physical Function Scale of the European Organization for Research and Treatment of Cancer Quality-of-Life-Questionnaire-Core-30 (EORTC QLQ-C30)
✕. Previous history of muscle-invasive bladder cancer or metastatic bladder cancer;
✕. Any history of upper tract urothelial carcinoma;
✕. Incarcerated in a detention facility or in police custody (patients wearing a monitoring device can be enrolled) at baseline/screening;
✕. Contraindication to radical cystectomy (e.g., American Society of Anesthesiologists (ASA) physical status of 4, patient not considered a radical cystectomy candidate due to comorbidity);
✕. Contraindication to medical therapy (i.e., intolerant of all medical therapies);
✕. Unable to provide written informed consent in English;