NL-OMON50424
Completed
Phase 4
REduce BlAdder CAncer REcurrence in patients treated for upper urinary tract urothelial carcinoma (REBACARE Trial) - REBACARE TRIA
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- urothelial cancer of the upper urinary tract
- Sponsor
- Erasmus MC, Universitair Medisch Centrum Rotterdam
- Enrollment
- 190
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
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.
Outcomes
Primary Outcomes
Not specified
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