Standard number and dose intravesical instillation therapy with BCG versus Reduced number and standard dose intravesical instillation therapy with BCG in patients with high grade non-muscle invasive urinary bladder carcinoma.
- Conditions
- on muscle invasive bladder cancer after transurethral resection of the Bladder Tumor (TURT).MedDRA version: 20.0Level: PTClassification code 10005003Term: Bladder cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2010-019181-91-ES
- Lead Sponsor
- EAU Foundation for Urological Research
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 824
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 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. Signed and dated informed consent form
8. 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 367
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 457
. 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Secondary end point(s): Number and grade of recurrent tumors.<br>Rate of progression to a higher stage (T2 or higher).<br>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.<br>This timepoint will also be used for evaluation of the the secondary end points.