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

December 13, 2023 updated by: Jørgen Bjerggaard Jensen
A randomized controlled trial aiming to investigate neoadjuvant, short-term intensive chemoresection with Mitomycin C compared to standard treatment with TURB and adjuvant intravesical instillation therapy in patients with recurrent non-muscle invasive bladder cancer (NMIBC).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Objectives:

To assess the efficacy of neoadjuvant, short-term intensive chemoresection with Mitomycin C compared to standard treatment with TURB and adjuvant intravesical instillation therapy in patients with recurrent non-muscle invasive bladder cancer (NMIBC).

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 Type

Interventional

Enrollment (Actual)

120

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aarhus, Denmark, 8200
        • Aarhus University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
Neoadjuvant Mitomycin C
Drug: Mitomycin c
Neoadjuvant Mitomycin C
Other Names:
  • Mitomycin "Medac"
Active Comparator: Control
Adjuvant Mitomycin C
Drug: Mitomycin c
Neoadjuvant Mitomycin C
Other Names:
  • Mitomycin "Medac"

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
within 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tumour response rate
Time Frame: 6 months after complete enrollment
Number of patients with complete, partial and incomplete tumour response on neoadjuvant, short-term intensive chemoresection with Mitomycin C.
6 months after complete enrollment
5-year recurrence rate
Time Frame: within 5 years

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 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.
within 5 years
Adverse events
Time Frame: 6 months after complete enrollment
Proportion of patients with adverse events related to neoadjuvant, short-term intensive chemoresection
6 months after complete enrollment
Biomarkers
Time Frame: within 2 years
Composition of 650 cancer-associated genes expressed on the last resected tumour
within 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jørgen Bjerggaard Jensen

Investigators

  • Principal Investigator: Jørgen Bjerggaard Jensen, MD, Aarhus University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2017

Primary Completion (Actual)

June 11, 2019

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

November 13, 2017

First Submitted That Met QC Criteria

November 16, 2017

First Posted (Actual)

November 21, 2017

Study Record Updates

Last Update Posted (Actual)

December 14, 2023

Last Update Submitted That Met QC Criteria

December 13, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DaBlaCa13

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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