Ignite Creation Date:
2025-12-24 @ 2:15 PM
Ignite Modification Date:
2025-12-24 @ 2:15 PM
Study NCT ID:
NCT02471495
Status:
WITHDRAWN
Last Update Posted:
2018-05-07
First Post:
2015-06-11
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
RITE-EUROPE (Radiofrequency-Induced Thermochemotherapy Effect-EUROPE)
Sponsor:
Medical Enterprises Europe B.V.
Organization:
Study Overview
Official Title:
A Multicenter, Single-Arm Study Evaluating the Efficacy of Synergo® Radiofrequency-Induced Thermochemotherapy Effect With Mitomycin C in Non-Muscle Invasive Bladder Cancer Patients With BCG-refractory CIS
Status:
WITHDRAWN
Status Verified Date:
2018-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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).
Detailed Description:
The study will consist of three periods: 1) Screening; 2) Induction, and 3) Maintenance treatment and follow-up.
Screening period After signing informed consent, patients will be screened for study eligibility by assessment of inclusion and exclusion criteria. Screening procedures will include collection of demographic data, medical history, physical examination, vital signs, and laboratory evaluations.
Induction period Patients will receive 8 weekly treatments of 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 Treatment and Follow-up Period
During the maintenance period, 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, unless the patient's participation in the study is terminated due to either:
1. a lack of complete response (at 6 months) or worsening of disease (at 3 months; see first and second follow-up control below), or
2. recurrence/progression Patients will be assessed by cystoscopy, urine cytology and, if required, subsequent biopsy or transurethral resection (TUR) of suspect areas every 3 months till the end of the study.
Two consecutive definite positive urine cytologies will be required to confirm persistent or recurrent disease if visual and biopsy are negative. In such cases, investigation of extravesical locations (CT-IVU, prostatic urethra biopsy) will be performed between the first and second urine cytology.
At the first follow-up control, i.e., 3 months after administration of the first study treatment, patients will undergo a cystoscopy evaluation.
Patients failing to achieve a disease-free state at the time of the first follow-up will continue in the study, unless a new occurrence of a T1 and/or high-grade lesion is found or any extra-bladder involvement is evident from pathological analysis.
At the second, i.e., 6-month, follow-up visit, patients will undergo biopsies of suspicious areas and random bladder biopsies of the trigone, bladder dome, right, left, anterior and posterior of the bladder wall. Upper tract washes will be performed in patients in whom urine cytology will be positive with no pathological evidence of NMIBC lesions in the bladder or the prostatic urethra. Patients failing to achieve a disease-free state at the time of the 6 month assessment and/or experiencing a new disease occurrence, demonstrated by cystoscopy and biopsy, and/or in whom extra-bladder involvement is suggested by a positive upper tract washes result will be removed from the study.
Upper tract imaging (CT-IVU imaging is recommended, IVU if CT not available) will be performed at 12 months from the first study treatment.
Extended treatment and follow-up period For longer-term disease-free-survival data collection purposes, patients free of tumor at the end of the study will be offered to continue receiving one Synergo® RITE + MMC treatment every 8 weeks. Each such treatment will last about 60 minutes and will consist of two 30-minute cycles with 40 mg MMC/50 ml sterile water for injection, each cycle. These treatments will be given until the end of 24 months after the patient's first induction treatment. See table 2 for details on the extended treatment and follow-up.
Screening period After signing informed consent, patients will be screened for study eligibility by assessment of inclusion and exclusion criteria. Screening procedures will include collection of demographic data, medical history, physical examination, vital signs, and laboratory evaluations.
Induction period Patients will receive 8 weekly treatments of 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 Treatment and Follow-up Period
During the maintenance period, 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, unless the patient's participation in the study is terminated due to either:
1. a lack of complete response (at 6 months) or worsening of disease (at 3 months; see first and second follow-up control below), or
2. recurrence/progression Patients will be assessed by cystoscopy, urine cytology and, if required, subsequent biopsy or transurethral resection (TUR) of suspect areas every 3 months till the end of the study.
Two consecutive definite positive urine cytologies will be required to confirm persistent or recurrent disease if visual and biopsy are negative. In such cases, investigation of extravesical locations (CT-IVU, prostatic urethra biopsy) will be performed between the first and second urine cytology.
At the first follow-up control, i.e., 3 months after administration of the first study treatment, patients will undergo a cystoscopy evaluation.
Patients failing to achieve a disease-free state at the time of the first follow-up will continue in the study, unless a new occurrence of a T1 and/or high-grade lesion is found or any extra-bladder involvement is evident from pathological analysis.
At the second, i.e., 6-month, follow-up visit, patients will undergo biopsies of suspicious areas and random bladder biopsies of the trigone, bladder dome, right, left, anterior and posterior of the bladder wall. Upper tract washes will be performed in patients in whom urine cytology will be positive with no pathological evidence of NMIBC lesions in the bladder or the prostatic urethra. Patients failing to achieve a disease-free state at the time of the 6 month assessment and/or experiencing a new disease occurrence, demonstrated by cystoscopy and biopsy, and/or in whom extra-bladder involvement is suggested by a positive upper tract washes result will be removed from the study.
Upper tract imaging (CT-IVU imaging is recommended, IVU if CT not available) will be performed at 12 months from the first study treatment.
Extended treatment and follow-up period For longer-term disease-free-survival data collection purposes, patients free of tumor at the end of the study will be offered to continue receiving one Synergo® RITE + MMC treatment every 8 weeks. Each such treatment will last about 60 minutes and will consist of two 30-minute cycles with 40 mg MMC/50 ml sterile water for injection, each cycle. These treatments will be given until the end of 24 months after the patient's first induction treatment. See table 2 for details on the extended treatment and follow-up.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: