Bladder CancerPhase 4NICSANCT03348969

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

A Phase 4 study testing Mitomycin c in people with Bladder Cancer, run by Jørgen Bjerggaard Jensen at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Bladder Cancer
What is being tested?: Mitomycin c
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 120 participants
Where: 1 siteDenmark
Study dates: 1 Nov 2017to 31 Dec 2025
Phase: Phase 4
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 12Show fewer

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

Trial locations and contacts

1 site in 1 country.

Denmark1 site

Aarhus University Hospital
Aarhus, 8200

Other trials in Denmark

About this study

Read the 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.

Conditions: Bladder Cancer
Being tested: Mitomycin c
Keywords: Mitomycin C, Neoadjuvant
Medical subject headings: Urinary Bladder Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Mitomycin cDrug
Also called Mitomycin "Medac"
Neoadjuvant Mitomycin C

Study groups in NCT03348969
Study group	Role	What they receive
Intervention	Experimental	Neoadjuvant Mitomycin C Receives: Drug: Mitomycin c
Control	Active comparator	Adjuvant Mitomycin C Receives: Drug: Mitomycin c

What is being measured

The primary outcome is the main question the study is designed to answer.

2-year recurrence rate
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.
Measured: within 2 years

Secondary outcomes (4)

Tumour response rate
Number of patients with complete, partial and incomplete tumour response on neoadjuvant, short-term intensive chemoresection with Mitomycin C.
Measured: 6 months after complete enrollment
5-year recurrence rate
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.
Measured: within 5 years
Adverse events
Proportion of patients with adverse events related to neoadjuvant, short-term intensive chemoresection
Measured: 6 months after complete enrollment
Biomarkers
Composition of 650 cancer-associated genes expressed on the last resected tumour
Measured: within 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Nov 201731 Dec 2025

First posted21 Nov 2017
Study start1 Nov 2017
Primary completion11 Jun 2019
Study completion31 Dec 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (15)Papers the sponsor has linked to this study.
Other trials for Bladder CancerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Randomized Clinical Trial
Masking: None (open label)
Enrolment: 120 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03348969
Sponsor's protocol ID: DaBlaCa13
Acronym: NICSA
Status last verified: Mar 2026
First submitted: 13 Nov 2017
Last updated: 3 Mar 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Herr H. Re: Marko Babjuk, Andreas Bohle, Maximilian Burger, et al. EAU Guidelines on Non-muscle-invasive Urothelial Carcinoma of the Bladder: Update 2016. Eur Urol 2017;71:447-61. Eur Urol. 2017 Jun;71(6):e171-e172. doi: 10.1016/j.eururo.2016.11.030. Epub 2016 Dec 12. No abstract available.
PubMed 27979427
Maffezzini M. Re: Richard J. Sylvester, Adrian P.M. van der Meijden, Willem Oosterlinck, J. Alfred Witjes, Christian Bouffioux, Louis Denis and Donald W.W. Newling. Predicting recurrence and progression in individual patients with stage Ta T1 bladder cancer using EORTC risk tables: a combined analysis of 2596 patients from seven EORTC trials. Eur Urol 2006;49:466-77. Eur Urol. 2006 Sep;50(3):623-4; author reply 624-5. doi: 10.1016/j.eururo.2006.04.005. Epub 2006 May 4. No abstract available.
PubMed 16707208
Kaasinen E, Wijkstrom H, Rintala E, Mestad O, Jahnson S, Malmstrom PU. Seventeen-year follow-up of the prospective randomized Nordic CIS study: BCG monotherapy versus alternating therapy with mitomycin C and BCG in patients with carcinoma in situ of the urinary bladder. Scand J Urol. 2016 Oct;50(5):360-8. doi: 10.1080/21681805.2016.1210672. Epub 2016 Aug 15.
PubMed 27603424
Lamm DL. Preventing progression and improving survival with BCG maintenance. Eur Urol. 2000;37 Suppl 1:9-15. doi: 10.1159/000052376.
PubMed 10575266
Shelley MD, Wilt TJ, Court J, Coles B, Kynaston H, Mason MD. Intravesical bacillus Calmette-Guerin is superior to mitomycin C in reducing tumour recurrence in high-risk superficial bladder cancer: a meta-analysis of randomized trials. BJU Int. 2004 Mar;93(4):485-90. doi: 10.1111/j.1464-410x.2003.04655.x.
PubMed 15008714
Shida K, Shimasaki J, Takahashi H, Kurihara H, Sato J. [Therapy and prognosis of bladder tumors--result of injection of mitomycin C into the bladder]. Gan No Rinsho. 1970 Jul;16(7):737-44. No abstract available. Japanese.
PubMed 5465489
Colombo R, Rocchini L, Suardi N, Benigni F, Colciago G, Bettiga A, Pellucchi F, Maccagnano C, Briganti A, Salonia A, Rigatti P, Montorsi F. Neoadjuvant short-term intensive intravesical mitomycin C regimen compared with weekly schedule for low-grade recurrent non-muscle-invasive bladder cancer: preliminary results of a randomised phase 2 study. Eur Urol. 2012 Nov;62(5):797-802. doi: 10.1016/j.eururo.2012.05.032. Epub 2012 May 18.
PubMed 22633362
Sousa A, Inman BA, Pineiro I, Monserrat V, Perez A, Aparici V, Gomez I, Neira P, Uribarri C. A clinical trial of neoadjuvant hyperthermic intravesical chemotherapy (HIVEC) for treating intermediate and high-risk non-muscle invasive bladder cancer. Int J Hyperthermia. 2014 May;30(3):166-70. doi: 10.3109/02656736.2014.900194. Epub 2014 Apr 3.
PubMed 24697672
Miyata Y, Sakai H. Predictive Markers for the Recurrence of Nonmuscle Invasive Bladder Cancer Treated with Intravesical Therapy. Dis Markers. 2015;2015:857416. doi: 10.1155/2015/857416. Epub 2015 Nov 23.
PubMed 26681820
Seo HK, Cho KS, Chung J, Joung JY, Park WS, Chung MK, Lee KH. Prognostic value of p53 and Ki-67 expression in intermediate-risk patients with nonmuscle-invasive bladder cancer receiving adjuvant intravesical mitomycin C therapy. Urology. 2010 Aug;76(2):512.e1-7. doi: 10.1016/j.urology.2010.04.040. Epub 2010 Jun 26.
PubMed 20579709
Chen JX, Deng N, Chen X, Chen LW, Qiu SP, Li XF, Li JP. A novel molecular grading model: combination of Ki67 and VEGF in predicting tumor recurrence and progression in non-invasive urothelial bladder cancer. Asian Pac J Cancer Prev. 2012;13(5):2229-34. doi: 10.7314/apjcp.2012.13.5.2229.
PubMed 22901199
Karam JA, Lotan Y, Ashfaq R, Sagalowsky AI, Shariat SF. Survivin expression in patients with non-muscle-invasive urothelial cell carcinoma of the bladder. Urology. 2007 Sep;70(3):482-6. doi: 10.1016/j.urology.2007.05.009.
PubMed 17905101
Bracci L, Schiavoni G, Sistigu A, Belardelli F. Immune-based mechanisms of cytotoxic chemotherapy: implications for the design of novel and rationale-based combined treatments against cancer. Cell Death Differ. 2014 Jan;21(1):15-25. doi: 10.1038/cdd.2013.67. Epub 2013 Jun 21.
PubMed 23787994
Hugo W, Zaretsky JM, Sun L, Song C, Moreno BH, Hu-Lieskovan S, Berent-Maoz B, Pang J, Chmielowski B, Cherry G, Seja E, Lomeli S, Kong X, Kelley MC, Sosman JA, Johnson DB, Ribas A, Lo RS. Genomic and Transcriptomic Features of Response to Anti-PD-1 Therapy in Metastatic Melanoma. Cell. 2017 Jan 26;168(3):542. doi: 10.1016/j.cell.2017.01.010. No abstract available.
PubMed 28129544
Lindgren MS, Hansen E, Azawi N, Nielsen AM, Dyrskjot L, Jensen JB. DaBlaCa-13 Study: Oncological Outcome of Short-Term, Intensive Chemoresection With Mitomycin in Nonmuscle Invasive Bladder Cancer: Primary Outcome of a Randomized Controlled Trial. J Clin Oncol. 2023 Jan 10;41(2):206-211. doi: 10.1200/JCO.22.00470. Epub 2022 Oct 12.
PubMed 36223555

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Neoadjuvant Short-term Intensive Chemoresection Versus Standard Adjuvant Intravesical Instillations in NMIBC
ClinicalTrials.gov ID: NCT03348969
Acronym / sponsor ID: NICSA / DaBlaCa13
Conditions: Bladder Cancer
Keywords: Mitomycin C, Neoadjuvant
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 120 participants (actual)
Lead sponsor: Jørgen Bjerggaard JensenUniversity, hospital or other
Study start: 1 Nov 2017 (actual)
Primary completion: 11 Jun 2019 (actual)
Study completion: 31 Dec 2025 (actual)
First posted: 21 Nov 2017 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Background:

Objectives:

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.

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

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: Randomized Clinical Trial

Arm	Type	Receives
Intervention	Experimental	Drug: Mitomycin cNeoadjuvant Mitomycin C
Control	Active comparator	Drug: Mitomycin cAdjuvant Mitomycin C

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (12 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Mitomycin cAlso: Mitomycin "Medac"Neoadjuvant Mitomycin C	Drug	Control, Intervention

Primary outcome

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.

4 secondary outcomes

Tumour response rate
Time frame: 6 months after complete enrollment
5-year recurrence rate
Time frame: within 5 years
Adverse events
Time frame: 6 months after complete enrollment
Biomarkers
Time frame: within 2 years

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2026.
Background: PubMed 27979427Herr H. Re: Marko Babjuk, Andreas Bohle, Maximilian Burger, et al. EAU Guidelines on Non-muscle-invasive Urothelial Carcinoma of the Bladder: Update 2016. Eur Urol 2017;71:447-61. Eur Urol. 2017 Jun;71(6):e171-e172. doi: 10.1016/j.eururo.2016.11.030. Epub 2016 Dec 12. No abstract available.
Background: PubMed 16707208Maffezzini M. Re: Richard J. Sylvester, Adrian P.M. van der Meijden, Willem Oosterlinck, J. Alfred Witjes, Christian Bouffioux, Louis Denis and Donald W.W. Newling. Predicting recurrence and progression in individual patients with stage Ta T1 bladder cancer using EORTC risk tables: a combined analysis of 2596 patients from seven EORTC trials. Eur Urol 2006;49:466-77. Eur Urol. 2006 Sep;50(3):623-4; author reply 624-5. doi: 10.1016/j.eururo.2006.04.005. Epub 2006 May 4. No abstract available.
Background: PubMed 27603424Kaasinen E, Wijkstrom H, Rintala E, Mestad O, Jahnson S, Malmstrom PU. Seventeen-year follow-up of the prospective randomized Nordic CIS study: BCG monotherapy versus alternating therapy with mitomycin C and BCG in patients with carcinoma in situ of the urinary bladder. Scand J Urol. 2016 Oct;50(5):360-8. doi: 10.1080/21681805.2016.1210672. Epub 2016 Aug 15.
Background: PubMed 10575266Lamm DL. Preventing progression and improving survival with BCG maintenance. Eur Urol. 2000;37 Suppl 1:9-15. doi: 10.1159/000052376.
Background: PubMed 15008714Shelley MD, Wilt TJ, Court J, Coles B, Kynaston H, Mason MD. Intravesical bacillus Calmette-Guerin is superior to mitomycin C in reducing tumour recurrence in high-risk superficial bladder cancer: a meta-analysis of randomized trials. BJU Int. 2004 Mar;93(4):485-90. doi: 10.1111/j.1464-410x.2003.04655.x.
Background: PubMed 5465489Shida K, Shimasaki J, Takahashi H, Kurihara H, Sato J. [Therapy and prognosis of bladder tumors--result of injection of mitomycin C into the bladder]. Gan No Rinsho. 1970 Jul;16(7):737-44. No abstract available. Japanese.
Background: PubMed 22633362Colombo R, Rocchini L, Suardi N, Benigni F, Colciago G, Bettiga A, Pellucchi F, Maccagnano C, Briganti A, Salonia A, Rigatti P, Montorsi F. Neoadjuvant short-term intensive intravesical mitomycin C regimen compared with weekly schedule for low-grade recurrent non-muscle-invasive bladder cancer: preliminary results of a randomised phase 2 study. Eur Urol. 2012 Nov;62(5):797-802. doi: 10.1016/j.eururo.2012.05.032. Epub 2012 May 18.
Background: PubMed 24697672Sousa A, Inman BA, Pineiro I, Monserrat V, Perez A, Aparici V, Gomez I, Neira P, Uribarri C. A clinical trial of neoadjuvant hyperthermic intravesical chemotherapy (HIVEC) for treating intermediate and high-risk non-muscle invasive bladder cancer. Int J Hyperthermia. 2014 May;30(3):166-70. doi: 10.3109/02656736.2014.900194. Epub 2014 Apr 3.
Background: PubMed 26681820Miyata Y, Sakai H. Predictive Markers for the Recurrence of Nonmuscle Invasive Bladder Cancer Treated with Intravesical Therapy. Dis Markers. 2015;2015:857416. doi: 10.1155/2015/857416. Epub 2015 Nov 23.
Background: PubMed 20579709Seo HK, Cho KS, Chung J, Joung JY, Park WS, Chung MK, Lee KH. Prognostic value of p53 and Ki-67 expression in intermediate-risk patients with nonmuscle-invasive bladder cancer receiving adjuvant intravesical mitomycin C therapy. Urology. 2010 Aug;76(2):512.e1-7. doi: 10.1016/j.urology.2010.04.040. Epub 2010 Jun 26.
Background: PubMed 22901199Chen JX, Deng N, Chen X, Chen LW, Qiu SP, Li XF, Li JP. A novel molecular grading model: combination of Ki67 and VEGF in predicting tumor recurrence and progression in non-invasive urothelial bladder cancer. Asian Pac J Cancer Prev. 2012;13(5):2229-34. doi: 10.7314/apjcp.2012.13.5.2229.
Background: PubMed 17905101Karam JA, Lotan Y, Ashfaq R, Sagalowsky AI, Shariat SF. Survivin expression in patients with non-muscle-invasive urothelial cell carcinoma of the bladder. Urology. 2007 Sep;70(3):482-6. doi: 10.1016/j.urology.2007.05.009.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jørgen Bjerggaard Jensen, MD principal investigator

Aarhus University Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Mitomycin c in people with Bladder Cancer, run by Jørgen Bjerggaard Jensen at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

2-year recurrence rate (time frame: within 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03348969, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2026.