NCT03348969CompletedPhase 4
Neoadjuvant Short-term Intensive Chemoresection Versus Standard Adjuvant Intravesical Instillations in NMIBC
Source: ClinicalTrials.gov · Last updated 3 Mar 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 120 (actual)
- First submitted
- 13 Nov 2017
- Start date
- 1 Nov 2017
- Primary completion date
- 11 Jun 2019
- Lead sponsor
- Jørgen Bjerggaard Jensen
- Diseases
- Bladder cancer
- NCT number
- NCT03348969
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 120
- From 1 Nov 2017 to the primary completion date, 11 Jun 2019
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous BCG-treatment within the last 24 months
- Previous Mitomycin C-treatment (except single-shot postoperative instillation)
Other illness
- Known history of invasive tumour of the bladder (T1+)
- Known history of CIS of the bladder
- Known allergy or intolerance to Mitomycin C
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Aarhus University Hospital Coordinator of this site? Confirm its status | Aarhus | Denmark | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.