High Grade Non-Muscle Invasive Urothelial Carcinoma of the Bladder malignant bladder cancer
Conditions
Interventions
After randomisation, study objects will have one of the two following 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.
Sponsors
European Association of Urology
Eligibility
Age
18 Years to 99 Years
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 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 tisssue) of the (initial) tumor site(s) 2b. In case of a T1 high grade 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 tisssue) 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 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 T1 low/high grade tumor 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 of the last BCG treatment. 7. Signed and dated informed consent form. 8. 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-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 within 5 years 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-installation intravesical chemotherapy in the last 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 |
|---|---|
| Primary endpoint is the time to first recurrence. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints: - number and grade of recurrent tumors - rate of progression to a higher stage (T2 or higher) - incidence and severity of side effects. | — |
Countries
Netherlands
Outcome results
None listed