Adding Mitomycin C to Bacillus of Calmette-Guerin (BCG) as Adjuvant Intravesical Therapy for High-risk Non-Muscle-invasive Bladder Cancer

  • STATUS
    Recruiting
  • participants needed
    500
  • sponsor
    University of Sydney
Updated on 8 November 2020
Concord Repatriation General Hospital (3.5 mi away) Contact
cancer
carcinoma
carcinoma in situ
mitomycin
bladder cancer
invasive bladder cancer
transurethral resection
cystoscopy
bladder tumor

Summary

Open label, randomised phase 3 trial of the addition of Mitomycin C to BCG as adjuvant intravesical therapy for high-risk, non-muscle-invasive bladder cancer. The study aim is to compare disease-free survival between treatment arms: BCG alone versus Mitomyicn C in addition to BCG.

Description

PROTOCOL SYNOPSIS

Background

Instillation of Bacillus of Calmette-Guerin (BCG) into the urinary bladder (intravesical administration) improves rates of disease recurrence and progression after transurethral resection (TUR) of high risk, non-muscle-invasive bladder cancer (NMIBC), but over 30% of people still recur despite optimal therapy with adjuvant intravesical BCG. The meta-analysis, including a recent randomised phase 2 trial, suggests that outcomes might be improved further by using an adjuvant intravesical regimen that includes both Mitomycin C (MMC) and BCG. These promising findings require corroboration in a definitive, large scale, randomised phase 3 trial using standard techniques for intravesical administration.

General Aim:

To determine the efficacy and safety of MMC in addition to BCG in patients with NMIBC.

Design

Open label, randomised, stratified, 2-arm multicentre phase 3 clinical trial. Population: The target population is adults with resected, high-risk NMIBC (high grade Ta or any grade T1) suitable for intravesical chemotherapy treatment. Key eligibility criteria include: prior transurethral resection of all visible tumour, adequate organ function, and ECOG performance status 0-2.

Study Treatments:

Arm A: Intravesical BCG Alone (standard): Induction (weekly x 6), followed by Maintenance (monthly x 10); or Arm B: Intravesical BCG + MMC (experimental): Induction (weekly x 9), followed by Maintenance (monthly x 9).

Statistical Considerations:

A sample size of 500 (followed until 213 events are observed) provides 85% power to detect a 10% improvement in DFS rate at 2 years from 70% on BCG alone to 80% on BCG and MMC (hazard ratio 0.63) at a significance level of 0.05, allowing for 10% non-compliance.

Details
Treatment Mitomycin C (MMC), Bacillus of Calmette-Guerin (BCG)
Clinical Study IdentifierNCT02948543
SponsorUniversity of Sydney
Last Modified on8 November 2020

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Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have bladder cancer?
Males or females with confirmed high grade pTa or stage pT1 (any grade) non-muscle invasive bladder cancer on initial or re-resection histology (concurrent carcinoma in situ is allowed)
Age >= 18 yrs
No macroscopically visible disease at cystoscopy within 8 weeks prior to randomisation. This may be either the initial Transurethral Resection of the Bladder Tumour (TURBT) at which the primary tumour was completely resected, or a planned second cystoscopy and/or re-resection done within 8 weeks of the initial TURBT
ECOG Performance Status of 0-2
Adequate bone marrow function
Adequate renal function
Adequate liver function
Study treatment both planned and able to start within 4 weeks of randomisation
Has completed the HRQL questionnaires or is unable to complete them because of literacy, insufficient English or limited vision
Willing and able to comply with all study requirements, including treatment, timing and/or nature of all required assessments
Signed, written informed consent

Exclusion Criteria

Contraindications or hypersensitivity to investigational products, BCG and Mitomycin C
Prior treatment with any other intravesical agent including BCG or Mitomycin C (excludes single doses given post TURBT)
Current or past transitional cell carcinoma (TCC) of the upper urinary tract
Prior muscle-invasive (stage T2 or higher) transitional-cell carcinoma of the bladder
Bladder dysfunction precluding intravesical therapy eg. Severe urinary incontinence or overactive or spastic bladder
Life expectancy < 3 months
Congenital or acquired immune deficiencies, whether due to a concurrent disease (e.g. acquired immune deficiency syndrome (AIDS), leukaemia, lymphoma) or immunosuppressive therapy (e.g. corticosteroids), or cancer therapy (cytotoxic drugs, radiation)
Prior radiotherapy of the pelvis
Prior or current treatment with radiotherapy-response or biological-response modifiers
Clinical evidence of existing active tuberculosis
History of another malignancy within 5 years prior to registration. Patients with non-melanomatous carcinoma of the skin are eligible for this study
Serious medical or psychiatric conditions that might limit the ability of the patient to comply with the protocol
Pregnancy, lactation, or inadequate contraception. Women must be post menopausal, infertile, or use a reliable means of contraception. Women of childbearing potential must have a negative pregnancy test done within 7 days prior to registration. Men must have been surgically sterilised or use a (double if required) barrier method of contraception
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