Neoadjuvant Short-term Intensive Chemoresection Versus Standard Adjuvant Intravesical Instillations in NMIBC (NICSA)
|
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. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT03348969 |
|
Recruitment Status :
Active, not recruiting
First Posted : November 21, 2017
Last Update Posted : January 13, 2021
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Bladder Cancer | Drug: Mitomycin c | Phase 4 |
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 (Clinical Trial) |
| Actual 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 |
| Actual Primary Completion Date : | June 11, 2019 |
| Estimated Study Completion Date : | October 31, 2021 |
| 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" |
- 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.
- 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
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.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
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
| Denmark | |
| Aarhus University Hospital | |
| Aarhus, Denmark, 8200 | |
| Principal Investigator: | Jørgen Bjerggaard Jensen, MD | Aarhus University Hospital |
| Responsible Party: | Jørgen Bjerggaard Jensen, Professor, MD, Aarhus University Hospital |
| ClinicalTrials.gov Identifier: | NCT03348969 |
| Other Study ID Numbers: |
DaBlaCa13 |
| First Posted: | November 21, 2017 Key Record Dates |
| Last Update Posted: | January 13, 2021 |
| Last Verified: | January 2021 |
| 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 |
|
Mitomycin C Neoadjuvant |
|
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 |