|- candidate number||27444|
|- NTR Number||NTR6545|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||21-jun-2017|
|- Secondary IDs||NL60919.078.17 OZBS62.14103|
|- Public Title||To investigate whether rinsing the bladder with chemotherapy right before an operation that removes the kidney and ureter because of a malignant tumor is effective to reduce the risk of a subsequent bladder tumor |
|- Scientific Title||Reduce Bladder Cancer Recurrence In Patients Treated For Upper Urinary Tract Urothelial Carcinoma|
|- hypothesis||A preoperative (<3 hours) intravesical instillation with Mitomycin will reduce the risk of a metachronous bladder tumor after radical nephroureterectomy or partial ureterectomy for urothelial carcinoma of the upper urinary tract. |
|- Healt Condition(s) or Problem(s) studied||Bladder cancer, Nephro-ureterectomy, Urothelial carcinoma, Upper urinary tract|
|- Inclusion criteria||- Histologically proven urothelial carcinoma of the upper urinary tract with or without concurrent carcinoma in situ (CIS only is allowed) or patients with a suspicion of a urothelial carcinoma of the UUT on CT-scan plus a urinary cytology sample showing high-grade urothelial carcinoma;|
-Patients planned to be treated either by partial ureterectomy or by a radical nephro-ureterectomy (open or laparoscopic) including a bladder cuff;
- Age ≥ 18 years;
- WHO perfomance status 0, 1 or 2;
- Negative pregnancy test in woman with childbearing potential;
- Written informed consent.
|- Exclusion criteria||- If pre-operative histology by biopsy shows aberrant histology of the UUT tumor of >50% (adenocarcinoma, small cell carcinoma, squamous cell carcinoma).|
- 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.
- 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 woman.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||Single arm|
|- planned startdate ||1-sep-2017|
|- planned closingdate||1-sep-2021|
|- Target number of participants||170|
|- Interventions||Intravesical instillation with Mitomycin within 3 hours before radical nephroureterectomy or partial ureterectomy.|
|- Primary outcome||The bladder cancer recurrence rate up to two years following surgery.|
|- Secondary outcome||- Compliance rate;|
- 2-year overall survival (OS), cancer-specific survival (CSS) and recurrence-free survival (RFS);
- Toxicity of the regime (CTCAE);
- Quality of life (EQ5D-5L, EORTC QLQ-C30);
- Calculation of costs of a single neoadjuvant instillation with Mitomycin;
- Molecular characterization of the upper urinary tract urothelial carcinoma and subsequent urothelial carcinoma of the bladder.
|- Timepoints||T0 = screening for elegibility|
T1 = inclusion, questionnaires (EQ5D-5L, EORTC QLQ-C30)
T2 = instillation, surgery, CTCAE
T3 = 1 month: postoperative controle and histology, CTCAE
T4 = 3 months: Cystoscopy, urine cytology, quistionnaires (EQ5D-5L, EORTC QLQ-C30)
T5 = 6 months: cystoscopy, urine cytology, CT urography, CT Thorax
T6 = 12 months: cystoscopy, urine cytology, CT urography, CT Thorax
T7 = 18 months: cystoscopy, urine cytology, CT urography
T8 = 24 months: cystoscopy, urine cytology, CT urography
|- Trial web site|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| Thomas van Doeveren|
|- CONTACT for SCIENTIFIC QUERIES||Dr. J.L. Boormans|
|- Sponsor/Initiator ||Erasmus Medical Center|
(Source(s) of Monetary or Material Support)
|KWF Kankerbestrijding, Integraal Kankercentrum Nederland (IKNL)|
|- Brief summary||A prospective, observational, cohort study to investigate the effect of a single, preoperative intravesical instillation with Mitomycin immediately before nephroureterectomy or partial ureterectomy for a urothelial carcinoma of the upper urinary tract on the risk for developping a bladder cancer recurrence compared to a historical control group who received no intravesical instillation.|
|- Main changes (audit trail)|
|- RECORD||21-jun-2017 - 26-jul-2017|