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Urinary Bladder NeoplasmsPhase 3SHTC-EUROPE-1NCT02254915

SHTC - EUROPE-1 Synergo Hyperthermia-Chemotherapy by European Urologists' Research Operation Preserving Evolution Study I

A Phase 3 study testing Synergo + MMC and Bacillus Calmette-Guérin in people with Urinary Bladder Neoplasms and Urologic Neoplasms, run by Medical Enterprises Europe B.V..

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Synergo + MMC and Bacillus Calmette-Guérin
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
Start not givento Jan 2020
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
  • All clinical, intra-operative and pathological items for the EAU risk stratification must be documented including a bladder map.
  • 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.
  • 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.
  • 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.
  • All patients must have urine cytology dated within the screening period prior to randomisation.
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  • Age ≥ 18 yrs
  • Normal kidneys and ureters.
  • Pre-treatment haematology and biochemistry values within acceptable limits:
  • 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)
  • Negative pregnancy test for women of child-bearing potential
  • A life expectancy at least of the duration of the trial.
  • Unfit or unwilling to have a full or partial cystectomy.
  • Signed informed consent.

Who cannot join

  • UC involving the prostatic urethra
  • Non-UC tumour of the urinary tract
  • Upper tract and intramural tumours (e.g. in Ostium).
  • History of stage > T1 UC.
  • CIS (suspected or present).
  • 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.
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  • Bleeding disorder
  • Macrohaematuria of ≥ 250 RBC's/uL or equivalent (e.g. > "+++" erythrocytes in a dipstick analysis).
  • Pregnant or 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 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.
  • More than low-dose Methotrexate (>17.5 mg once a week).
  • 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.
  • Any known allergy or adverse event that would prevent them from receiving a treatment that they may be randomised to within the trial.
  • 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.
  • Bladder diverticula with cumulative diameter > 1cm
  • UTI at any time within 6 months preceding randomisation.
  • Significant urinary incontinence (spontaneous, requiring use of pads)
  • History of pelvic irradiation
  • 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.
  • Participation in another study which includes treatment that is liable to have an effect on this study.

About this study

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)

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.

Being tested
Synergo + MMC, Bacillus Calmette-Guérin
Keywords
Synergo, RITE, SHTC, Non Muscle Invasive Bladder Cancer, NMIBC, Superficial Bladder Cancer, Urothelial Cell Cancer, Transitional Cell Cancer, Mitomycin
Medical subject headings
Urinary Bladder Neoplasms, Urologic Neoplasms, Urogenital Neoplasms, Neoplasms, Neoplasms by Site, Urinary Bladder Diseases, Urologic Diseases, Non-Muscle Invasive Bladder Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Synergo + MMCDevice

    Also called RITE, SHTC

    Synergo radiofrequency (RF)-Induced hyperthermia-chemotherapy with mitomycin C (RITE). Intravesical instillation of MMC utilizing the Synergo system.

  • Bacillus Calmette-GuérinDrug

    Also called BCG

    Intravesical instillation of BCG.

Study groups in NCT02254915
Study groupRoleWhat they receive
Synergo + MMCExperimentalSynergo radiofrequency (RF)-Induced hyperthermia-chemotherapy (SHTC) with mitomycin C (RITE) intravesical therapy as first-line adjuvant treatment for intermediate and high-risk NMIBC,
Receives: Device: Synergo + MMC
Bacillus Calmette-GuérinActive comparatorIntravesical BCG therapy as first-line adjuvant treatment for intermediate and high-risk NMIBC,
Receives: Drug: Bacillus Calmette-Guérin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. RFS time

    The recurrence-free survival time in patients with NMIBC following treatment with SHTC (investigational arm) compared to BCG (controlled arm).

    Measured: 2 years

Secondary outcomes (7)

  1. Progression-free survival time

    Measured: 2 years

  2. Recurrence free survival time by risk group

    Measured: 2 years

  3. Organ preservation rate

    Measured: 2 years

  4. Overall survival time

    Measured: 2 years

  5. Disease-specific survival time

    Measured: 2 years

  6. Adverse events

    Safety (rate of adverse events), as well as tolerability of SHTC compared to BCG in terms of the frequency, severity and nature of adverse events and the treatment received.

    Measured: 2 years

  7. Treatment discontinuation

    Proportion of treatment discontinuation of SHTC compared to BCG

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Oct 2014 (estimated)
  2. Primary completionJan 2020 (estimated)

Why it stopped: Shortages of the active comparator drug (BCG) on the market worldwide and a growing uncertainty as to its future supply.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02254915
Sponsor's protocol ID
CLN-002-00
Acronym
SHTC-EUROPE-1
Status last verified
Mar 2015
First submitted
30 Sep 2014
Last updated
1 Apr 2015
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Synergo + MMC and Bacillus Calmette-Guérin in people with Urinary Bladder Neoplasms and Urologic Neoplasms, run by Medical Enterprises Europe B.V..

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 1 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

RFS time (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02254915.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2015.

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