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

Phase 1

• Conditions: pper Tract Urothelial Carcinoma (UTUC).; MedDRA version: 20.0Level: HLGTClassification code 10038364Term: Renal and urinary tract neoplasms malignant and unspecifiedSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0Level: HLGTClassification code 10038365Term: Renal and urinary tract therapeutic proceduresSystem Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2017-000949-53-NL
• Lead Sponsor: Erasmus MC, Dept. Urology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-04-12
• Last Update Posted: 15 June 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• 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 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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 90

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 clinical trial of medicinal product
• Study Design: Not specified