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Neoadjuvant Short-term Intensive Chemoresection Versus Standard Adjuvant Intravesical Instillations in NMIBC (NICSA)

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ClinicalTrials.gov Identifier: NCT03348969
Recruitment Status : Recruiting
First Posted : November 21, 2017
Last Update Posted : January 17, 2018
Sponsor:
Information provided by (Responsible Party):
Jørgen Bjerggaard Jensen, Aarhus University Hospital

Study Description
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Brief Summary:
To investigate the ability to predict chemo-response in patients with recurrent non-muscle invasive bladder cancer (NMIBC).

Condition or disease Intervention/treatment Phase
Bladder Cancer Drug: Mitomycin c Phase 3

Detailed Description:

Background:

Bladder cancer is the 11th most common cancer in the world and one of the most costly cancers on a per patient basis, due to the cost of operative procedures, follow-up cystoscopies and instillation therapy. Furthermore there is a risk of progression to invasive and hence deadly cancer why efficient and immediate treatment is crucial. Treatment today consists of surgical removal of tumours (TURB) and adjuvant intravesical treatment. There is a chance; neoadjuvant intravesical treatment with chemotherapy can supersede surgical removal in chemo-sensitive tumours while however some tumours will not respond to intravesical chemotherapy. Currently it is not possible to predict which tumours are chemo-sensitive and which are not.

Objective:

To investigate the ability to predict chemo-response in patients with recurrent non-muscle invasive bladder cancer (NMIBC).

Methods:

A randomised clinical controlled trial will include 120 patients with recurrent NMIBC.

The control group of 60 patients will receive standard care with TURB and adjuvant intravesical treatment. The intervention group of 60 patients will be submitted to neoadjuvant short-term intensive chemoresection with three instillations with Mitomycin C per week for two weeks. Remnant tumour tissue will be evaluated by flexible cystoscopy after four weeks.

To investigate the ability to predict chemo-response in patients with recurrent NMIBC, a connection between biomarkers of the initial tumour tissue and tumour response will be assessed.

Samples of the latest resected tumour prior to inclusion will be collected from all participants treated with neoadjuvant chemoresection and assessed against the tumour response seen in the trial.

Perspectives:

Validation of biomarkers to predict chemo-response will be an important step to integrate biomarkers in daily clinical practice and to individualize the treatment of NMIBC.

In some cases surgery could be avoided while ineffective chemotherapy could be avoided in others.


Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized Clinical Trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Neoadjuvant Short-term Intensive Chemoresection Versus Standard Adjuvant Intravesical Instillations in NMIBC
Actual Study Start Date : November 1, 2017
Estimated Primary Completion Date : November 1, 2018
Estimated Study Completion Date : October 31, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Intervention
Neoadjuvant Mitomycin C
 Drug: Mitomycin c
Neoadjuvant Mitomycin C
Other Name: Mitomycin "Medac"
Active Comparator: Control
Adjuvant Mitomycin C
 Drug: Mitomycin c
Neoadjuvant Mitomycin C
Other Name: Mitomycin "Medac"


Outcome Measures
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Primary Outcome Measures :
  1. 2-year recurrence rate [ Time Frame: within 2 years ]

    The primary outcome is the number of patients in need for a TURB or tumour fulguration in the first 2 years following randomization.

    TURBs included as primary endpoint are the initial TURB in the control group, the prospective TURB in the intervention group for patients without complete chemoresection as well as TURB due to recurrence in both study groups. In case a TURB is recommended, but a subject refuses to undergo surgery, the recommended TURB is also registered.



Secondary Outcome Measures :
  1. 5-year recurrence rate [ Time Frame: within 5 years ]

    Outcome number two is the number of patients in need of a TURB or tumour fulguration in the outpatient clinic in the first 5 years following randomization.

    TURBs included as primary endpoint are the initial TURB in the control group, the prospective TURB in the intervention group for patients without complete chemoresection as well as TURB due to recurrence in both study groups. In case a TURB is recommended, but a subject refuses to undergo surgery, the recommended TURB is also registered.



Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Known history of urothelial non-invasive Ta-tumour low-grade or high-grade.
  • ≥18 years old
  • Mentally healthy individual
  • The ability to understand Danish orally and in writing

Exclusion Criteria:

  • Known history of invasive tumour of the bladder (T1+)
  • Known history of CIS of the bladder
  • Previous BCG-treatment within the last 24 months
  • Previous Mitomycin C-treatment (except single-shot postoperative instillation)
  • Known allergy or intolerance to Mitomycin C
  • Solid tumour with suspicions of invasion
  • Single tumour of more than 2 cm in diameter
  • Suspicion of CIS (positive cytology with high-grade neoplastic cells combined with suspicious cystoscopy for flat lesions).
  • Small bladder volume (less than 100 ml) or incontinence
  • Acute cystitis
  • Pregnancy or breast-feeding
  • Not willing to use secure contraception with regard to men with partners and premenopausal women
Contacts and Locations
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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): NCT03348969


Contacts
Contact: Jørgen Bjerggaard Jensen +4530915682 bjerggaard@skejby.rm.dk
Contact: Maria Skydt Lindgren +4530915431 maalin@rm.dk

Locations
Denmark
Aarhus University Hospital Recruiting
Aarhus, Denmark, 8200
Contact: Jørgen Bjerggaard Mr Jensen    +4530915682    bjerggaard@skejby.rm.dk   
Contact: Maria Skydt Ms Lindgren    +4530915431    maalin@rm.dk   
Sponsors and Collaborators
Jørgen Bjerggaard Jensen
Investigators
Principal Investigator: Jørgen Bjerggaard Jensen, MD Aarhus University Hospital
More Information
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Publications:

Responsible Party: Jørgen Bjerggaard Jensen, Professor, MD, Aarhus University Hospital
ClinicalTrials.gov Identifier: NCT03348969     History of Changes
Other Study ID Numbers: DaBlaCa13
First Posted: November 21, 2017    Key Record Dates
Last Update Posted: January 17, 2018
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Jørgen Bjerggaard Jensen, Aarhus University Hospital:
Mitomycin C
Neoadjuvant

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Mitomycins
 Mitomycin
Antibiotics, Antineoplastic
Antineoplastic Agents
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors