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.

Phase 1

• 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-FR
• Lead Sponsor: EAU Foundation for Urological Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-05-10
• Last Update Posted: 6 October 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 824

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified