SHTC - EUROPE-1 Synergo Hyperthermia-Chemotherapy by European Urologists' Research Operation Preserving Evolution Study I
Information source: Medical Enterprises Europe B.V.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Urinary Bladder Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms; Neoplasms by Site; Urinary Bladder Diseases; Urologic Diseases
Intervention: Synergo + MMC (Device); Bacillus Calmette-Guérin (Drug)
Phase: Phase 3
Status: Withdrawn
Sponsored by: Medical Enterprises Europe B.V. Official(s) and/or principal investigator(s): Igal Ruvinsky, PhD, Study Director, Affiliation: Medical Enterprises Europe B.V. Gerson Luedecke, Dr. med., Principal Investigator, Affiliation: Universitätsklinikum Gießen und Marburg
Summary
A multi-institutional, prospective, randomised, open-label, superiority, comparative,
active-controlled, phase 3 study. The study will compare Synergo RF-induced
hyperthermia-chemotherapy (SHTC) plus mitomycin C (MMC) to standard treatment of bacillus
Calmette-Guérin (BCG) therapy as first-line adjuvant treatment for intermediate and
high-risk NMIBC, and will evaluate recurrence and progression rate over two years of
follow-up.
Clinical Details
Official title: A Multi-Centre, Randomised, Open-Label Active-Controlled Study Comparing Safety and Efficacy of Synergo Radiofrequency (RF)-Induced Hyperthermia-Chemotherapy With Mitomycin C (RITE) Versus Bacillus Calmette-Guérin (BCG) as First-Line Treatment of Non-Muscle Invasive Papillary Bladder Cancer (NMIBC)
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: RFS time
Secondary outcome: Progression-free survival timeRecurrence free survival time by risk group Organ preservation rate Overall survival time Disease-specific survival time Adverse events Treatment discontinuation
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. Patients with primary intermediate or high-risk papillary NMIBC according to the EAU
Guidelines and intermediate and high-risk recurrences that have not received BCG
within the previous 2 years or chemotherapy treatment (apart from one early
instillation) within the previous year.
2. All clinical, intra-operative and pathological items for the EAU risk stratification
must be documented including a bladder map.
3. Patients must have undergone a re-resection (second TURB in accordance with the EAU
Guidelines) (i) if the initial TURB was incomplete (ii) if there was no muscle in the
specimen after the initial TURB (except in TaG1/LG tumours) (iii) in all T1 and all
G3/HG tumours TURB of T1 sites must include muscle. Re-resection must be negative in
patients diagnosed with T1 and/or G3/HG and/or multiple tumours in the initial TURB.
4. No UC in the upper tract, kidney and ureters. This should be confirmed by CT-IVU or
IVU performed at time of initial diagnosis in selected cases as recommended in latest
EAU guidelines published prior to screening.
5. No UC in the urethra, excluded by visual inspection during cystoscopy and, in
addition, in patients with (i) tumour of trigone (ii) tumour of bladder neck (iii)
abnormal prostatic urethra UC must be excluded by biopsy of the prostatic urethra in
all male patients or, in female patients, from the portion of the urethra adjacent to
the bladder neck, before study recruitment.
6. All patients must have urine cytology dated within the screening period prior to
randomisation.
7. Age ≥ 18 yrs
8. Normal kidneys and ureters.
9. Pre-treatment haematology and biochemistry values within acceptable limits:
(i) haemoglobin ≥ 10 g/dl (g/100 ml) (ii) platelets ≥ 150 x 109/L (103/mm3)
(iii) WBC ≥ 3. 0 x 109/L (103/mm3) (iv) ANC ≥ 1. 5 x 109/L (103/mm3,
absolute neutrophil count) (v) Serum creatinine, SGOT, SGPT, Alkaline phosphatase: <
1. 5 x UNL (upper normal limit)
10. Negative pregnancy test for women of child-bearing potential
11. A life expectancy at least of the duration of the trial.
12. Unfit or unwilling to have a full or partial cystectomy.
13. Signed informed consent.
Exclusion Criteria:
1. UC involving the prostatic urethra
2. Non-UC tumour of the urinary tract
3. Upper tract and intramural tumours (e. g. in Ostium).
4. History of stage > T1 UC.
5. CIS (suspected or present).
6. 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.
7. Bleeding disorder
8. Macrohaematuria of ≥ 250 RBC's/uL or equivalent (e. g. > "+++" erythrocytes in a
dipstick analysis).
9. Pregnant or lactating women.
10. Women of childbearing potential unwilling or unable to use adequate contraception if
sexually active.
11. More than a maintenance dose of oral corticosteroids (maintenance dose defined as the
same dose regimen over the past 6 months for a condition requiring continual
corticosteroid treatment) or patients with an immuno-compromised state for any
reason.
12. More than low-dose Methotrexate (>17. 5 mg once a week).
13. Other malignancy within the past five years, except: non-melanomatous skin cancer
cured by excision, adequately 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.
14. Any known allergy or adverse event that would prevent them from receiving a treatment
that they may be randomised to within the trial.
15. Known untreated strictural disease or bladder neck contracture or any other condition
that may prevent catheterisation with 21F catheter. Patients may undergo dilation or
urethral incision before entering the study.
16. Bladder diverticula with cumulative diameter > 1cm
17. UTI at any time within 6 months preceding randomisation.
18. Significant urinary incontinence (spontaneous, requiring use of pads)
19. History of pelvic irradiation
20. Patients with implanted electronic devices (such as cardiac pacemakers) unless they
receive permission from their treating physician (e. g., cardiologist) and are
monitored by a treating physician during the treatment session.
21. Participation in another study which includes treatment that is liable to have an
effect on this study.
Locations and Contacts
Additional Information
Medical Enterprises ongoing trials
Last updated: March 31, 2015
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