Non-Muscle Invasive Urothelial Carcinoma of the Bladder. Niet spierinvasief urothelial carcinoma van de blaas
Conditions
Interventions
This is a multicentre prospective, randomized, parallel group, not blinded, trial to compare the efficacy and safety of two different adjuvant treatment schedules:
1) Induction cycle BCG-full dose
weeks 1 through 6 plus maintenance cycles at months 3, 6 and 12 (wks 1,2,3)
total 15 full dose BCG instillations
2) Induction cycle BCG-full dose (reduced frequency)
weeks 1,2, and 6 plus maintenance cycles at months 3, 6 and 12 (wks 1,3)
total 9 full dose BCG instillations.
BCG intravesical instillation therapy is registered as adjuvant treatment for the prevention of recurrence of NMIBC and can be considered as standard treatment for
bi-annually until the fifth year and yearly thereafter.
Sponsors
EAU Research Foundation
Arnhem, the Netherlands
Eligibility
Inclusion criteria
Inclusion criteria: 1. Presence of high grade (Ta-T1) urothelial carcinoma of the bladder with or without CIS 1.a. Tumors can be primary or recurrent; 1.b. Tumors can be single or multiple. 2a. In case of a Ta high grade tumor in the initial resection, a re-TUR can be performed at the discretion of the investigator. Initial resection or re-TUR must include the deep resection or cold cup biopsy (deep enough to obtain muscle tissue) of the (initial) tumor site(s) 2b. In case of a T1 high grade tumor in the initial resection, a 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 tissue) of the initial tumor site(s) 3. Re-re-TUR should be performed at weeks 4-8 after re-TUR in case of histological detection of T1 low/high grade tumor in the re-TUR, which must include the deep resection or cold cup biopsy (deep enough to obtain muscle tissue) of the initial tumor site(s) 4. Histopathologically confirmed absence of T1 low/high grade tumor(s) in the re-TUR specimen and/or re-re-TUR specimen 5. All visible papillary tumors must be completely resected 6. If the patient is male, he must use a condom during sexual intercourse during the first week after BCG treatment. If the patient is female, and of childbearing potential, she must practice adequate contraception for 30 days prior to administration of study treatment, have a negative pregnancy test and continue such precautions during all study treatment period and for 3 months after the last BCG treatment. 7. Patient is clinically fit enough to receive BCG bladder instillations.
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-)re-TUR surgical specimens 4. Presence of any tumors in upper urinary tract or in the prostatic urethra at any time 5. Presence of any other histological type of resected tumor other than urothelial carcinoma on the first or second resection 6. Presence of another malignancy in the 5 years before randomisation except for basal cell carcinoma of the skin or localised prostate cancer in active surveillance 7. Presence of pregnancy or lactation 8. Presence of active tuberculosis, any form of immunodeficiency (eg HIV + serology, transplant recipients) and/or any other contraindication of BCG therapy 9. Patients who have received any systemic cytostatic agents or multi-instillation intravesical chemotherapy in the 3 months prior to randomisation. Early postoperative (within 6 hours of resection) single dose chemotherapy is allowed after the first resection. However, it should not be given after (re-)re-TUR if the patient is considered eligible for this study. 10. Patients with uncontrollable UTI.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to first recurrence | — |
Secondary
| Measure | Time frame |
|---|---|
| - Number and grade of recurrent tumors; - Rate of progression to a higher stage (T2 or higher); - Incidence and severity of side effects. | — |
Contacts
Public ContactWim P.J. Witjes
P.O. Box 30016
Outcome results
None listed