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

• Status: Unknown status
• Trial end date: 2020-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Sydney
• Collaborators: Australian and New Zealand Urogenital and Prostate Cancer Trials Group; Cancer Australia
• Treatments: BCG Vaccine; Mitomycin; Mitomycins

Criteria

Inclusion Criteria:

1. 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).

2. Age >= 18 yrs

3. 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.

4. ECOG Performance Status of 0-2

5. Adequate bone marrow function

6. Adequate renal function

7. Adequate liver function

8. Study treatment both planned and able to start within 4 weeks of randomisation

9. Has completed the HRQL questionnaires or is unable to complete them because of literacy, insufficient English or limited vision

10. Willing and able to comply with all study requirements, including treatment, timing and/or nature of all required assessments

11. Signed, written informed consent

Exclusion Criteria:

1. Contraindications or hypersensitivity to investigational products, BCG and Mitomycin C

2. Prior treatment with any other intravesical agent including BCG or Mitomycin C (excludes single doses given post TURBT)

3. Current or past transitional cell carcinoma (TCC) of the upper urinary tract

4. Prior muscle-invasive (stage T2 or higher) transitional-cell carcinoma of the bladder

5. Bladder dysfunction precluding intravesical therapy eg. Severe urinary incontinence or overactive or spastic bladder

6. Life expectancy < 3 months

7. 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)

8. Prior radiotherapy of the pelvis

9. Prior or current treatment with radiotherapy-response or biological-response modifiers

10. Clinical evidence of existing active tuberculosis

11. History of another malignancy within 5 years prior to registration. Patients with non-melanomatous carcinoma of the skin are eligible for this study.

12. Serious medical or psychiatric conditions that might limit the ability of the patient to comply with the protocol.

13. 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.