urothelial cancer of the upper urinary tract Urothelial carcinoma of the upper urinary tract
Conditions
Interventions
A single intravesical instillation of Mitomycin within three hours before
surgery.
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Patients with histologically proven urothelial carcinoma of the UUT with or without concurrent carcinoma in situ (CIS only is also allowed) or patients with a suspicion of a urothelial carcinoma of the UUT on CTscan with or without a urinary cytology sample suspicious of the presence of high-grade urothelial carcinoma. In case urinary cytology shows no abnormality and no diagnostic URS is done, conclusive results of the CT-urography are sufficient for inclusion and the coordinating investigator will evaluate the eligibility of the subject in consultation with the local investigator. - Patients treated either by partial ureterectomy or by a radical nephro-ureterectomy (open or laparoscopic) including a bladder cuff. - Age >= 18 years. - WHO performance status 0,1, or 2. - Negative pregnancy test in women with childbearing potential. - Written informed consent.
Exclusion criteria
Exclusion criteria: - If pre-operative histology obtained by biopsy: aberrant histology of the UUT tumor of >50% (adenocarcinoma, small cell carcinoma, squamous cell carcinoma). - Postoperative pathological report shows absence of tumor (pT0) or >50% of the UUT tumor shows aberrant histology. - History or presence of a malignant tumor or carcinoma in situ of the bladder. - History of UUT urothelial carcinoma on the contralateral side or presence of bilateral UUT urothelial carcinoma. - Known allergy against Mitomycin. - Anticipated adjuvant intravesical treatment with chemo- or immunotherapy. - Anticipated adjuvant intravesical treatment with chemo- or immunotherapy following a diagnostic URS. - Acute urinary tract infection at the time of inclusion as assessed by urinary culturing. - Lymphadenopathy or distant metastases as assessed by preoperative CT-scan of thorax and abdomen. - Any other concurrent severe or uncontrolled disease preventing the safe administration of intravesical Mitomycin. - Breastfeeding women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary end point is the bladder recurrence rate (histologically proven urothelial carcinoma) at two years after surgery for an UUT urothelial carcinoma. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) To show a >80% compliance rate and accurate and consistent protocol performance of treating physicians. 2) The overall, cancer-specific, and recurrence-free survival at two years after surgery. 3) The toxicity of the regimen at three months (CTCAE version 4.0). 4) The quality of life of the subjects will be assessed at inclusion (T0, before surgery and neo-adjuvant treatment), at two weeks (T2) and three months (T3) after surgery. The EQ5D-5L and the EORTC QLQ-C30 will be used. 5) Costs from a societal perspective using a time horizon of two years. The costs consist of direct costs (e.g., personnel costs of health professionals involved, disorder related medication, disorder related innervations, time duration of hospital, informal care) and indirect costs (productivity loss) associated with each regimen. 6) Incremental cost-effectiveness ratios. The economic evaluation will be a cost-utility analysis and a cost-effectiveness analysis performed from a societal perspective. 7) At inclusion, patients will be asked to provide consent on the use of their tumor tissue for molecular analysis. Whole genome sequencing will be performed to investigate tumor-specific somatic mutations and copy number variations to compare the molecular profile of the primary UUT tumor and subsequent bladder tumor. | — |
Countries
Netherlands
Outcome results
None listed