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Closed (no longer recruiting)Last updated: 12 February 2024

BCG+MMC: This phase III trial is looking at the effect of adding mitomycin C (a chemotherapy drug) to standard treatment, in patients with invasive bladder cancerAdding mitomycin C to Bacillus of Calmette-Guerin (BCG) as adjuvant intravesical therapy for high-risk, non-muscle invasive bladder cancer: a randomised phase 3 trial.

Clinical summary

Summary

Summary The purpose of this study is to determine the effect of adding mitomycin C (a chemotherapy drug) to best current treatment in patients with high-risk non-muscle invasive bladder cancer. Who is it for? You may be eligible to join this study if you are at least 18 years of age and have been diagnosed with non-muscle invasive bladder cancer. You should have undergone transurethral resection of the bladder tumour (TURBT) within 8 weeks prior to enrolment with no visible disease remaining. Trial details Non-muscle invasive bladder cancer is common, causes substantial suffering, and requires radical removal or irradiation of the bladder within 5 years in over 30% of people with high risk tumours despite best current treatment. Recent preliminary studies show promising results from adding mitomycin C, a chemotherapy drug, to best current treatment with BCG. Participants in this trial will be randomly (by chance) allocated to one of two groups. Participants in one group will receive the current standard treatment. This involves direct instillation of the drug, Bacillus of Calmette-Guerin (BCG) into the bladder weekly for 6 weeks, and then monthly for 10 months. Participants in the other group with receive BCG and the chemotherapy drug, mitomycin C, via instillation into the bladder weekly for 9 weeks, and then monthly for 9 months. Participants will be regularly assessed for up to 5 years in order to determine the effects of adding mitomycin C on cure rates, survival, side effects, and quality of life.

Conditions

This trial is treating patients with bladder cancer.

Cancer

Urinary System Cancers Genitourinary

Age

People18+

Phase

III

Trial Acronym

BCG+MMC

More information

Trial Identifiers

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Trial sponsor

Australian & New Zealand Urogenital and Prostate Cancer Trials Group Limited (ANZUP)

Scientific Title

Adding mitomycin C to Bacillus of Calmette-Guerin (BCG) as adjuvant intravesical therapy for high-risk, non-muscle invasive bladder cancer: a randomised phase 3 trial.

Eligibility

Inclusion

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 greater than or equal to 18 yrs
3. No macroscopically visible disease at cystoscopy within 8 weeks prior to randomisation. This may either be the initial 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, renal and liver function confirmed by pre-randomisation blood tests.
6. Study treatment both planned and able to start within 4 weeks of randomisation
7. Is willing to complete HRQL questionnaires or is unable to complete them because of literacy, insufficient English or limited vision
8. Willing and able to comply with all study requirements, including treatment, timing and/or nature of all required assessments
9. Signed, written informed consent

Exclusion

1. Contraindications or hypersensitivity to investigational products, BCG and MM
2. Prior treatment with any other intravesical agent including BCG or MM (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 e.g. 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.

Inclusion

  • Your cancer has not spread to other parts of the body.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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