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

NCT02471495 | Withdrawn Phase 3 DMC

• 1 other identifier: RITE-2
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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).

Conditions

Bladder Cancer

Keywords

NMIBC; Non-Muscle-Invasive Bladder Cancer; Nonmuscle Invasive Bladder Cancer; BCG refractory; BCG failure; Carcinoma in situ; CIS

Outcome Measures

Primary Outcomes (1)

• Recurrence-free survival

  The study will be deemed successful if the recurrence-free survival probability after 12 months is at least 30%.

  12 months

Secondary Outcomes (3)

• Complete Response Rate (CRR)

  6 months after first treatment

• Rate of serious adverse events

  12 months

• Proportion of patients who discontinue treatment for safety reasons.

  12 months

Study Arms (1)

Synergo® RITE + MMC

EXPERIMENTAL

Induction Patients will receive 8 weekly treatments of Synergo® RITE + MMC, using the Synergo® System. Each treatment lasts about 60 minutes and consists of two 30-minute cycles with 40 mg MMC/50 ml sterile water for injection each cycle. These 8 treatments will be followed by a pause (see Table 1), after which a follow-up cystoscopy (first follow-up control) will be conducted during Weeks 12-13 (from the first treatment). Maintenance Patients will receive one Synergo® RITE + MMC treatment every 6 weeks. Each treatment lasts about 60 minutes and consists of two 30-minute cycles with 40 mg MMC/50 ml sterile water for injection each cycle. Maintenance treatments will be given until the end of 12 months after the patient's first induction treatment.

Device: Synergo® RITE + MMC

Interventions

Synergo® RITE + MMC DEVICE

Synergo® system delivers homogenous microwave hyperthermia to the bladder wall in combination with bladder instillation of cold chemotherapeutic agent - Mitomycin C (MMC).The energy-delivering unit and the intravesical irrigation system are computer-controlled, The irrigation system consists of a disposable tubing line and catheter set. The catheter is a triple-lumen, silicone, transurethral Foley-type catheter. MMC is constituted as a powder (40 mg) dissolved in 50 ml sterile water for injection.

Synergo® RITE + MMC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with CIS, with or without coexisting papillary NMIBC, who either:
• fail to achieve a disease-free status by 6 months after initial BCG therapy, with maintenance or re-induction at 3 months due to either persistent or rapidly recurrent disease, or
• experience a worsening in NMIBC state following initial BCG therapy presenting with a new NMIBC instance, other than TaLG.
• 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:
• if the initial TUR was incomplete.
• if there was no muscle in the specimen after the initial TUR (except in TaLG tumors).
• in all T1 tumors. TUR of T1 sites must include muscle.
• in all HG tumors \> 3cm.
• 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:
• tumor of trigone,
• tumor of bladder neck, or
• abnormal prostatic urethra

You may not qualify if:

• 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.
• Macrohematuria of ≥ 250 RBC/uL or equivalent (e.g., \> "+++" erythrocytes in a dipstick analysis) within 4 weeks before treatment start.
• Lactating women.
• Women of childbearing potential unwilling or unable to use adequate contraception if sexually active.
• More than a maintenance dose of oral corticosteroids (maintenance dose is defined as the same dose regimen over the past 6 months for a condition requiring continual corticosteroid treatment) or patients with an immunocompromised state for any reason.
• More than low-dose methotrexate (\>17.5 mg once a week).
• Other malignancy within the past 5 years, except: non-melanomatous skin cancer cured by excision, surgically treated carcinoma in situ of the cervix or ductal CIS (DCIS)/lobular CIS (LCIS) of the breast or stable prostate cancer (under active surveillance or hormone control) with a life expectancy of more than 5 years.
• Any known allergy (e.g., to MMC) or adverse event that would prevent a prospective study participant from receiving the study treatment.

Sponsors & Collaborators

• Medical Enterprises Europe B.V.: lead

MeSH Terms

Conditions

Urinary Bladder Neoplasms; Non-Muscle Invasive Bladder Neoplasms; Carcinoma in Situ

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Igal Ruvinsky, PhD

  Medical Enterprises

  STUDY DIRECTOR

• Shariat Shahrokh, Prof. med

  Medical University Vienna, General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2015
• First Posted: June 15, 2015
• Study Start: September 1, 2016
• Primary Completion: January 1, 2019
• Study Completion: January 1, 2020
• Last Updated: May 7, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share