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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 : Active, not recruiting
First Posted : November 21, 2017
Last Update Posted : January 13, 2021
Sponsor:
Information provided by (Responsible Party):
Jørgen Bjerggaard Jensen, Aarhus University Hospital

Tracking Information
First Submitted Date  ICMJE November 13, 2017
First Posted Date  ICMJE November 21, 2017
Last Update Posted Date January 13, 2021
Actual Study Start Date  ICMJE November 1, 2017
Actual Primary Completion Date June 11, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 16, 2017)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 13, 2019)
  • 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.
  • 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.
  • Adverse events [ Time Frame: 6 months after complete enrollment ]
    Proportion of patients with adverse events related to neoadjuvant, short-term intensive chemoresection
  • Biomarkers [ Time Frame: within 2 years ]
    Composition of 650 cancer-associated genes expressed on the last resected tumour
Original Secondary Outcome Measures  ICMJE
 (submitted: November 16, 2017)
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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Neoadjuvant Short-term Intensive Chemoresection Versus Standard Adjuvant Intravesical Instillations in NMIBC
Official Title  ICMJE Neoadjuvant Short-term Intensive Chemoresection Versus Standard Adjuvant Intravesical Instillations in NMIBC
Brief Summary 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).
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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Randomized Clinical Trial
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Bladder Cancer
Intervention  ICMJE Drug: Mitomycin c
Neoadjuvant Mitomycin C
Other Name: Mitomycin "Medac"
Study Arms  ICMJE
  • Experimental: Intervention
    Neoadjuvant Mitomycin C
    Intervention: Drug: Mitomycin c
  • Active Comparator: Control
    Adjuvant Mitomycin C
    Intervention: Drug: Mitomycin c
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: November 16, 2017)
120
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 31, 2021
Actual Primary Completion Date June 11, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03348969
Other Study ID Numbers  ICMJE DaBlaCa13
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Jørgen Bjerggaard Jensen, Aarhus University Hospital
Study Sponsor  ICMJE Jørgen Bjerggaard Jensen
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jørgen Bjerggaard Jensen, MD Aarhus University Hospital
PRS Account Aarhus University Hospital
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP