WithdrawnPhase 3

RITE-EUROPE (Radiofrequency-Induced Thermochemotherapy Effect-EUROPE)

0Started 2016-09

Plain-language summary

This multicenter, prospective, single-arm, phase 3 study will assess the proportion of disease-free patients, starting from administration of the first study treatment to at least 12-months after the first treatment, and up to 2 years (the latter only in patients choosing to participate in longer-term disease-free-survival data collection).

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Patients with CIS, with or without coexisting papillary NMIBC, who either:
✓. All clinical, intra-operative and pathological items for the EAU risk stratification must be documented including a bladder map.
✓. Patients with papillary disease must have undergone a repeat TUR:
✓. CT-IVU or IVU confirmation of absence of tumor(s) in the upper tract, kidney and ureters performed within 6 months before the treatment initiation in selected cases as recommended in latest EAU guidelines published prior to screening. If IVU protocol not available or contrast allergy/poor renal function preclude such imaging, then non-contrast CT or MRI of the abdomen/pelvis within the same timeframe will suffice.
✓. Visual inspection to exclude urothelial carcinoma (UC) in the urethra during cystoscopy.
✓. Biopsy of the prostatic urethra in male patients prior to recruitment to exclude UC of the prostatic urethra, in patients with:
✓. All patients must have urine cytology collected from either voided urine or bladder wash within the screening period prior to recruitment.
✓. All patients must have prostatic urethral biopsies collected within the screening period prior to recruitment.

Exclusion criteria

✕. Non-UC tumor of the urinary tract.
✕. Upper tract and intramural tumors (e.g., in ostium).
✕. Positive selective cytology from the upper tract.
✕. History of stage \> T1 UC.
✕. Papillary tumor in repeat TUR in patients diagnosed with HG \> 3cm and/or T1 in the initial TUR.
✕. Papillary tumor ≥ T1 in repeat TUR
✕. Known or suspected reduced bladder capacity. Patients will have a US estimation of maximum bladder capacity or void spontaneously the maximum they can retain in their bladder, and this will be used to determine urine volume. A minimum volume of 250 ml is required.
✕. Bleeding disorder.

What they're measuring

Recurrence-free survival

Timeframe: 12 months

Trial details

NCT IDNCT02471495

SponsorMedical Enterprises Europe B.V.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-01

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