REduce BlAdder CAncer REcurrence in patients treated for upper urinary tract urothelial carcinoma (REBACARE Trial) - REBACARE TRIA

Erasmus MC, Dept. Urology0 sites190 target enrollmentApril 12, 2017

Overview

No summary available.

Registry

who.int

Start Date

April 12, 2017

End Date

TBD

Last Updated

5 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

Erasmus MC, Dept. Urology

•\- 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 CT\-scan 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.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1\.2 Adults (18\-64 years) yes
•F.1\.2\.1 Number of subjects for this age range 100

•\- 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.