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Evaluating the Effect of Pre-TURBT Intravesical Instillation of Mitomycin C (MMC) Mixed With TC-3 Gel in Patients With Non Muscle Invasive Bladder Cancer (NMIBC)

21 Years
Not Enrolling
Non Muscle Invasive Bladder Cancer

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Trial Information

Evaluating the Effect of Pre-TURBT Intravesical Instillation of Mitomycin C (MMC) Mixed With TC-3 Gel in Patients With Non Muscle Invasive Bladder Cancer (NMIBC)

Non-muscle-Invasive Bladder cancer is mainly treated by tumor resection (Trans Urethral
Resection - TUR), followed by series of intravesical instillations of prophylactic
chemotherapeutic drugs as Mitomycin C (MMC) or BCG. This treatment approach is limited due
to rapid dilution the chemotheraputic drug by the incoming urine and clearance by urination.

TheraCoat core technology is based on a reverse thermal biodegradable gel (TC-3) (low
viscosity at 5°C gel appearance at body temperature)for drug retention in the urinary

Prior to instillation, the TC-3 hydrogel, in a liquid state, is mixed with MMC.TC-3 mixed
with MMC is instilled to the bladder by a catheter. Following gel insertion to the bladder,
the gel solidifies and forms a drug reservoir inside the bladder. Upon contact with urine
the gel dissolves and is cleared out from the bladder.

Intravesical MMC instillation using TheraCoat gel is expected to increase treatment
efficiency due to prolongation of treatment duration and consequently improving bladder
exposure to MMC.

Treatment Protocol - Immediately following baseline cystoscopy and tumor diagnosis and
patient undergoes 6 weekly instillations followed by 2-4 weeks healing period.

1st Follow-Up Visit (Pre-Scheduled TURBT Visit): The patient will undergo a second
Cystoscopy to compare to the Baseline status and after that a follow-up period: 3,6,9,12

Inclusion Criteria:

- Single or multiple tumors (n≤7)

- Recurrent tumor.

- No prior history of HG and/or T1 and/or Tis

- At least one Tumor ≥ 1mm.

- Largest tumor diameter ≤ 30mm

- Cystoscopic appearance of papillary Low grade tumor

- The patient had upper urinary tract evaluation in the previous year excluding
urothelial carcinoma, hydronephrosis,Renal Cell Carcinoma or other renal cancers.

- Good performance status (Karnofsky performance status 70% or greater).

Exclusion Criteria:

- Sensitivity to MMC

- Acute urinary Tract Infection(UTI)

- Upper urinary tract obstruction.

- Treatment with intravesical chemotherapy within the 3 last months

- Cystoscopic Appearance suspicious for HG and/or solid and/or Tis

- The patient did not have at least 3 months cystoscopically confirmed tumor-free
interval between the last tumor recurrence and screening.

- Pregnant women as diagnosed by Beta - HCG, or women that are suspected to be

- Brest feeding women

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

ablative effect of pre-TURBT intravesical instillations of the treatments on The bladder lesion(s) of NMIBC patients

Outcome Description:

Cystoscopic and pathological effect (evaluated during TUR-BT visit) of pre-TURBT intravesical instillations with 40 mg of MMC mixed with 60cc TC-3 Hydrogel on bladder lesion(s) of NMIBC patients. At To, which is the time of identification of a recurrent tumor by cystoscopy, the number, size and location of the lesions will be documented and photographed. Each tumor size will be evaluated by photographing a ureter catheter adjacent to the tumor. Since the ureter catheter diameter is a pre-known variable, the tumor diameter can be calculated using specific software developed for study purposes. Photography of the tumor with a pre-known diameter ureter catheter will be performed during the same cystoscopy as described above and will be evaluated by a central clinic for uniformity of measurements, and the results of these measurements will serve for the post study evaluation of the change in tumor diameter

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Fred Witjes, Prof

Investigator Role:

Principal Investigator

Investigator Affiliation:

Radboud University Nijmegen Medical Centre, Department of Urology Geert Grooteplein South 10 (659), Nijmegen


Italy: Ministry of Health

Study ID:




Start Date:

May 2013

Completion Date:

Related Keywords:

  • Non Muscle Invasive Bladder Cancer
  • Non Muscle Invasive Bladder Cancer
  • Intravesical instillation
  • Mitomycin C
  • Hydrogel Reverse thermal gelation
  • Drug retention
  • Intravesical Instillation
  • Additional relevant MeSH terms:
  • Urinary Bladder Neoplasms
  • Carcinoma
  • Urologic Neoplasms
  • Urogenital Neoplasms
  • Neoplasms by Site
  • Neoplasms
  • Urinary Bladder Diseases
  • Urologic Diseases
  • Neoplasms, Glandular and Epithelial
  • Neoplasms by Histologic Type Mitomycins
  • Mitomycin
  • Antibiotics, Antineoplastic
  • Antineoplastic Agents
  • Therapeutic Uses
  • Pharmacologic Actions
  • Nucleic Acid Synthesis Inhibitors
  • Enzyme Inhibitors
  • Molecular Mechanisms of Pharmacological Action
  • Alkylating Agents
  • Urinary Bladder Neoplasms