A Phase 4 interventional study of Mitomycin c in Bladder Cancer, sponsored by Jørgen Bjerggaard Jensen. Completed at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-03.
Sponsored by Jørgen Bjerggaard Jensen · Phase 4, Interventional, and Treatment
A randomized controlled trial aiming to investigate neoadjuvant, short-term intensive chemoresection with Mitomycin C compared to standard treatment with TURB and adjuvant intravesical instillation therapy in patients with recurrent non-muscle invasive bladder cancer (NMIBC).
Background:
Bladder cancer is the 11th most common cancer in the world and one of the most costly cancers on a per patient basis, due to the cost of operative procedures, follow-up cystoscopies and instillation therapy. Furthermore there is a risk of progression to invasive and hence deadly cancer why efficient and immediate treatment is crucial. Treatment today consists of surgical removal of tumours (TURB) and adjuvant intravesical treatment. There is a chance; neoadjuvant intravesical treatment with chemotherapy can supersede surgical removal in chemo-sensitive tumours while however some tumours will not respond to intravesical chemotherapy. Currently it is not possible to predict which tumours are chemo-sensitive and which are not.
Objectives:
To assess the efficacy of neoadjuvant, short-term intensive chemoresection with Mitomycin C compared to standard treatment with TURB and adjuvant intravesical instillation therapy in patients with recurrent non-muscle invasive bladder cancer (NMIBC).
To investigate the ability to predict chemo-response in patients with recurrent non-muscle invasive bladder cancer (NMIBC).
Methods:
A randomised clinical controlled trial will include 120 patients with recurrent NMIBC.
The control group of 60 patients will receive standard care with TURB and adjuvant intravesical treatment. The intervention group of 60 patients will be submitted to neoadjuvant short-term intensive chemoresection with three instillations with Mitomycin C per week for two weeks. Remnant tumour tissue will be evaluated by flexible cystoscopy after four weeks.
To investigate the ability to predict chemo-response in patients with recurrent NMIBC, a connection between biomarkers of the initial tumour tissue and tumour response will be assessed.
Samples of the latest resected tumour prior to inclusion will be collected from all participants treated with neoadjuvant chemoresection and assessed against the tumour response seen in the trial.
Perspectives:
Validation of biomarkers to predict chemo-response will be an important step to integrate biomarkers in daily clinical practice and to individualize the treatment of NMIBC.
In some cases surgery could be avoided while ineffective chemotherapy could be avoided in others.
Exclusion Criteria:
Neoadjuvant Mitomycin C
Drug: Mitomycin c
Adjuvant Mitomycin C
Drug: Mitomycin c
Neoadjuvant Mitomycin C
Also known as: Mitomycin "Medac"
2-year recurrence rate
The primary outcome is the number of patients in need for a TURB or tumour fulguration in the first 2 years following randomization. TURBs included as primary endpoint are the initial TURB in the control group, the prospective TURB in the intervention group for patients without complete chemoresection as well as TURB due to recurrence in both study groups. In case a TURB is recommended, but a subject refuses to undergo surgery, the recommended TURB is also registered.
Time frame: within 2 years
Tumour response rate
Number of patients with complete, partial and incomplete tumour response on neoadjuvant, short-term intensive chemoresection with Mitomycin C.
Time frame: 6 months after complete enrollment
5-year recurrence rate
The number of patients in need of a TURB or tumour fulguration in the outpatient clinic in the first 5 years following randomization. TURBs included are the initial TURB in the control group, the prospective TURB in the intervention group for patients without complete chemoresection as well as TURB due to recurrence in both study groups. In case a TURB is recommended, but a subject refuses to undergo surgery, the recommended TURB is also registered.
Time frame: within 5 years
Adverse events
Proportion of patients with adverse events related to neoadjuvant, short-term intensive chemoresection
Time frame: 6 months after complete enrollment
Biomarkers
Composition of 650 cancer-associated genes expressed on the last resected tumour
Time frame: within 2 years
Plan to share: No
This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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Jørgen Bjerggaard Jensen