Clinical trial · Interventional
Neoadjuvant Short-term Intensive Chemoresection Versus Standard Adjuvant Intravesical Instillations in NMIBC
NCT03348969CI-TRIAL-00104467NICSAcompletedPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Mitomycin c | Drug | Mitomycin | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Intervention
- description
- Neoadjuvant Mitomycin C
- interventionNames
- Drug: Mitomycin c
- type
- ACTIVE_COMPARATOR
- label
- Control
- description
- Adjuvant Mitomycin C
- interventionNames
- Drug: Mitomycin c
Primary outcomes (1)
- measure
- 2-year recurrence rate
- timeFrame
- within 2 years
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (15)
- BACKGROUNDHerr 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. PMID 27979427
- BACKGROUNDMaffezzini 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. PMID 16707208
- BACKGROUNDKaasinen 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. PMID 27603424
- BACKGROUNDLamm DL. Preventing progression and improving survival with BCG maintenance. Eur Urol. 2000;37 Suppl 1:9-15. doi: 10.1159/000052376. PMID 10575266
- BACKGROUNDShelley 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. PMID 15008714
- BACKGROUNDShida 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.