A preoperative (
ID
Bron
Verkorte titel
Aandoening
Bladder cancer (blaaskanker), chemotherapy (chemotherapie), nephro-ureterectomy (nefro-ureterectomie), upper urinary tract (hogere urinewegen), urothelial carcinoma (urotheelcelcarcinoom)
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
The bladder cancer recurrence rate up to two years following surgery.
Achtergrond van het onderzoek
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.
Doel van het onderzoek
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.
Onderzoeksopzet
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
Onderzoeksproduct en/of interventie
Intravesical instillation with Mitomycin within 3 hours before radical nephroureterectomy or partial ureterectomy.
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- 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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- 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.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL6361 |
| NTR-old | NTR6545 |
| CCMO | NL60919.078.17 |
| OMON | NL-OMON50424 |