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

Phase 4

Completed

Conditions: urothelial cancer of the upper urinary tract
Urothelial carcinoma of the upper urinary tract
10038364
10046400

Registration Number: NL-OMON50424

Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 190

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
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.

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.
- 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.
- Breastfeeding women.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary end point is the bladder recurrence rate (histologically proven<br /><br>urothelial carcinoma) at two years after surgery for an UUT urothelial<br /><br>carcinoma.</p><br>

Secondary Outcome Measures