Non muscle invasive bladder cancer after transurethral resection of the Bladder Tumor (TURT). MedDRA version: 20.0 Level: PT Classification code 10005003 Term: Bladder cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: BCG-medac
Pharmaceutical Form: Intravesical solution
Trade Name: BCG-medac. The IMP used in this (test) study arm is the same as the (comparator) standard arm but used in a reduced frequ
Sponsors
EAU Foundation for Urological Research
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Presence of high grade (Ta-T1) urothelial papillary carcinoma of the bladder with or without CIS 1.1. Tumors can be primary or recurrent 1.2. Tumors can be single or multiple 2. Re-TUR should be performed at weeks 4-8 after initial resection, which must include the deep resection or cold cup biopsy (deep enough to obtain muscle tisssue) of the initial tumor site(s) 3. Re-re-TUR should be performed in case of histological detection of high grade papillary NMIBC in the re-TUR, which must include the deep resection or cold cup biopsy (deep enough to obtain muscle tisssue) of the initial tumor site(s) 4. Histopathologically confirmed absence of high-grade papillary NMIBC in the re-TUR specimen and/or re-re-TUR specimen 5. All visible papillary tumors must be completely resected 6. Early postoperative (within 6 hours of resection) single dose chemotherapy is allowed after the first resection. However, it should not be given after re-TUR if the patient is considered eligible for this study 7. Prior multi-instillation intravesical chemotherapy is allowed, provided that the last instillation was completed 3 months before randomisation in this study. 8. Signed and dated informed consent form. 9. Patient is clinically fit enough to receive BCG bladder instillations. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 100 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 100
Exclusion criteria
Exclusion criteria: 1. Any previous intravesical BCG therapy 2. Presence of primary CIS only. 3. Presence of histopathologically proven muscle invasive urothelial carcinoma of the bladder at first or re-TUR surgical specimens 4. Patients with incomplete resection of visible tumors 5. Absence of muscle tissue in the re-TUR specimen(s) 6. Presence of any upper urinary tract tumors at any time 7. Presence of any other histological type of resected tumor other than urothelial carcinoma on the first or second resection 8. Presence of another malignancy other than the basal cell carcinoma of the skin or localised prostate cancer in active surveillance 9. Presence of pregnancy or lactation 10. Presence of active tuberculosis, any form of immunodeficiency (eg HIV + serology, transplant recipients) and/or any other contraindication of BCG therapy 11. Patients who have received any systemic cytostatic agents within the last 3 months 12. Patients with uncontrollable UTI
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to identify if reduced number of BCG instillations are not inferior to standard number and dose intravesical BCG treatment in patients with high grade NMIBC. The primary endpoint for inferiority analysis is time to first recurrence.;Secondary Objective: The secondary objectives are to identify if number and grade of recurrent tumors, rate of progression to a higher stage (T2 or higher) of the disease and safety, specifically the presence of treatment related toxicity > grade 2 differ between the two study arms. ;Primary end point(s): Time to first recurrence.;Timepoint(s) of evaluation of this end point: Timepoint after randomisation at which the date of first recurrence of the disease occurs up to a maximum of 5 years from the first administration of BCG Vaccine for intravesical instillation. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Number and grade of recurrent tumors. Rate of progression to a higher stage (T2 or higher). Incidence and severity of side effects, specifically the presence of treatment related toxicity > Grade 2. ;Timepoint(s) of evaluation of this end point: Timepoint after randomisation at which the date of first recurrence of the disease occurs up to a maximum of 5 years from the first administration of BCG Vaccine for intravesical instillation. | — |
Countries
Belgium, France, Germany, Spain
Contacts
Public ContactProject Manager
EAU Foundation for Urological Research
Outcome results
None listed