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van CCT (UK)


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van CCT (UK)


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


- candidate number27444
- NTR NumberNTR6545
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR21-jun-2017
- Secondary IDsNL60919.078.17 OZBS62.14103
- Public TitleTo 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 TitleReduce Bladder Cancer Recurrence In Patients Treated For Upper Urinary Tract Urothelial Carcinoma
- ACRONYMREBACARE
- hypothesisA 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) studiedBladder 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 receivedyes
- multicenter trialyes
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-sep-2017
- planned closingdate1-sep-2021
- Target number of participants170
- InterventionsIntravesical instillation with Mitomycin within 3 hours before radical nephroureterectomy or partial ureterectomy.
- Primary outcomeThe 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.
- TimepointsT0 = 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
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES Thomas van Doeveren
- CONTACT for SCIENTIFIC QUERIESDr. J.L. Boormans
- Sponsor/Initiator Erasmus Medical Center
- Funding
(Source(s) of Monetary or Material Support)
KWF Kankerbestrijding, Integraal Kankercentrum Nederland (IKNL)
- Publications
- Brief summaryA 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)
- RECORD21-jun-2017 - 26-jul-2017


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