Therapeutic Instillation of Mistletoe (TIM)
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|ClinicalTrials.gov Identifier: NCT02106572|
Recruitment Status : Recruiting
First Posted : April 8, 2014
Last Update Posted : April 26, 2022
|Condition or disease||Intervention/treatment||Phase|
|Superficial Bladder Cancer||Drug: abnobaVISCUM 900 Drug: Mitomycin C||Phase 3|
This is a randomized, open-label, active-controlled, prospective, multinational Phase III confirmative study with 2 treatment groups and an adaptive design (Bauer and Köhne, 1994). The study is designed to compare the efficacy of treatment with abnobaVISCUM® 900 with Mitomycin C (MMC). Patients with completely resected superficial bladder carcinoma (Stage Ta) with an intermediate risk classification according to the European Association of Urology (EAU, update 2013) and with one immediately post operative MMC 40 mg intravesical instillation will be eligible for inclusion in the study.
The study comprises a screening period of not more than 6 weeks, a treatment period of 12 months for abnobaVISCUM® 900 and MMC and a follow-up period of 12 months. Patients will be screened within 6 weeks after the transurethral resection of the bladder (TURB) and the immediately post operative MMC 40 mg intravesical instillation. A re-resection should be performed before inclusion if indicated. Every patient is to provide written informed consent before any study related procedures will be performed.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||546 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Masking Description:||Blind Review in accordance with with ICH-Biostatistics Guideline ICH E9|
|Official Title:||Intravesical Mistletoe Extract in Superficial Bladder Cancer: A Phase III Efficacy Study|
|Actual Study Start Date :||April 2015|
|Estimated Primary Completion Date :||December 2024|
|Estimated Study Completion Date :||June 2025|
Experimental: abnobaVISCUM 900
intravesical instillation of abnobaVISCUM 900
Drug: abnobaVISCUM 900
intravesical instillation of abnobaVISCUM 900 13 times during treatment period
Active Comparator: Mitomycin C
intravesical instillation of Mitomycin C
Drug: Mitomycin C
intravesical instillation of Mitomycin C 10 times during treatment period
- Time to tumor recurrence [ Time Frame: up to two years ]The primary objective of the study is to assess the efficacy of abnobaVISCUM® 900. Primary efficacy criterion will be the time to tumor recurrence.
- Toxicity and tolerability of the study medication [ Time Frame: up to two years ]The secondary objective, namely safety including toxicity and tolerability of the study medication, will be assessed by the monitoring of adverse events (AEs) according to the Common Terminology Criteria for Adverse Events (CTCAE), laboratory assessments (hematology, biochemistry and urinalysis) and a global judgment of tolerability.
- Prognosis after 1 year for recurrence and progression [ Time Frame: 1 year ]A secondary efficacy endpoint is prognosis after 1 year for recurrence and progression, estimated by the European Organization for Research and Treatment of Cancer (EORTC) Bladder Cancer Calculator.
- Quality of Life with the EORTC QLQ-C30 and BLS24 Quality of Life Questionnaires [ Time Frame: up to two years ]A secondary efficacy endpoint is measurement of Quality of Life with the EORTC QLQ-C30 and BLS24 questionnaires.
- Tumor grading [ Time Frame: up to two years ]A secondary efficacy endpoint is the tumor grading in case of a recurrence by cytology, ultrasound, and cystoscopy.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02106572
|Contact: Juergen Eisenbraun, Dr.||+49 7233 7043 firstname.lastname@example.org|
|Principal Investigator:||Stephan Tschirdewahn, Dr.||Senior Physician of the Urological Clinic of the University Hospital Essen|