Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Sequential Combination Therapy in Bladder Cancer (MITOBCG)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03790384
Recruitment Status : Not yet recruiting
First Posted : December 31, 2018
Last Update Posted : December 31, 2018
Sponsor:
Information provided by (Responsible Party):
Azienda Ospedaliera "Sant'Andrea"

Brief Summary:
A consecutive series of patients with High Risk Non-Muscle Invasive Bladder Cancer will be enrolled in several centres. The subjects will be assessed for eligibility at the screening visit (Visit 1) three weeks after Trans-Urethral Resection of the Bladder (TURB) and re-TURB prior to randomization and only subjects who fulfil the inclusion criteria will be included. Patients selected for the study, are centrally randomized (randomization is performed at the Sant'Andrea Hospital) to receive BCG induction treatment according to the standard protocol (an instillation once a week for six weeks) with Immucyst (81 mg Connaught strain BCG). Patients in group two received BCG treatment with the same protocol with a 40 mg mitomycin instillation the day before .

Condition or disease Intervention/treatment Phase
Bladder Cancer Drug: Mitomycin Phase 4

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The subjects will be assessed for eligibility at the screening visit (Visit 1) three weeks after TURB and re-TURB prior to randomization and only subjects who fulfil the inclusion criteria will be included: patients with a diagnosis of High risk NMIBC: T1 tumor, G3, CIS, or multiple and recurrent and large (>3 cm) Ta or patients in the last EAU recurrence category (EAU/EORTC recurrence score >/=10). Patients selected for the study, are centrally randomized (randomization is performed at the Sant'Andrea Hospital) to receive BCG induction treatment according to the standard protocol (an instillation once a week for six weeks) with ImmuCyst (81 mg Connaught strain BCG). Patients in group two received BCG treatment with the same protocol with a 40 mg mitomycin instillation the day before .
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: The Effects of Sequential Mitomycin and Bacillus Calmette-Guérin Treatment Versus Bacillus Calmette-Guérin Monotherapy in Patients With High Risk Non-Muscle Invasive Bladder Cancer
Estimated Study Start Date : January 15, 2019
Estimated Primary Completion Date : September 15, 2019
Estimated Study Completion Date : January 15, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bladder Cancer

Arm Intervention/treatment
No Intervention: Bacillus Calmette-Guérin
Patients receive Bacillus Calmette-Guérin induction treatment according to the standard protocol (an instillation once a week for six weeks) with ImmuCyst (81 mg Connaught strain BCG).
Experimental: Mytomicin and Bacillus Calmette-Guérin
Patients received BCG treatment with the same protocol. Intervention will be a 40 mg mitomycin instillation the day before every single BCG instillation
Drug: Mitomycin
Patients receive BCG induction treatment according to the standard protocol (an instillation once a week for six weeks) with ImmuCyst (81 mg Connaught strain BCG) with a 40 mg mitomycin instillation the day before .
Other Name: Bacillus Calmette-Guerin




Primary Outcome Measures :
  1. Recurrence rate [ Time Frame: 2 years ]
    To evaluate the effect in term of recurrence rate of sequential combination therapy of Mitomycin and Bacillus Calmette-Guérin versus Bacillus Calmette-Guérin monotherapy in patients with High grade Non-Muscle Invasive Bladder Cancer.through cystoscopy every three months and Uro Tomography Computerized yearly


Secondary Outcome Measures :
  1. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: 2 years ]
    To evaluate the overall toxicity of sequential combination therapy of Mitomycin and Bacillus Calmette-Guérin versus Bacillus Calmette-Guérin monotherapy through CTCAE v4.0. Patients have to fill in International Prostate Symptoms Score, NIH-CPSI, PUF questionaries. Every three months patients will be visited and have a cystoscopy. We will hear about self-reported symptoms and we will measure body temperature



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients with high risk non muscle invasive bladder cancer
  • High risk of progression (EORTC risk score > 6)
  • Males
  • Signature of Informed Consent
  • Ability of consent

Exclusion Criteria:

  • Low Risk Non-Muscle Invasive Bladder Cancer
  • Muscle Invasive Bladder Cancer
  • Concomitant Urothelial Bladder Cancer in the Upper-Urinary Tract
  • Previous bladder or prostate surgery
  • Prostate or bladder radiotherapy
  • Urinary tract infection
  • Chronic urinary retention or indwelling catheters
  • Neurological patients
  • Previous BCG infections
  • Previous or current chemotherapy for other kind of cancers
  • Patients older than 75
  • WHO performance status 3-4
  • Residual tumour on re-TURB

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03790384


Contacts
Layout table for location contacts
Contact: Andrea Tubaro +390633777712 andrea.tubaro@mac.com

Sponsors and Collaborators
Azienda Ospedaliera "Sant'Andrea"
Investigators
Layout table for investigator information
Principal Investigator: Andrea Tubaro Azienda Ospedaliera "Sant'Andrea"

Publications:
Layout table for additonal information
Responsible Party: Azienda Ospedaliera "Sant'Andrea"
ClinicalTrials.gov Identifier: NCT03790384     History of Changes
Other Study ID Numbers: 2017-004540-37
First Posted: December 31, 2018    Key Record Dates
Last Update Posted: December 31, 2018
Last Verified: December 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Mitomycins
Mitomycin
BCG Vaccine
Antibiotics, Antineoplastic
Antineoplastic Agents
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs