EUCTR2017-001189-98-DK
Active, not recruiting
Phase 1
eoadjuvant short-term Intensive Chemoresection versus Standard Adjuvant intravesical instillations in NMIBC - A study on effect and tolerability of neoadjuvant short-term intensive chemoresection and molecular markers for prediction of chemo-response - NICSA
ConditionsPatients with recurrent non-muscle invasive bladder cancerMedDRA version: 20.0Level: LLTClassification code 10005004Term: Bladder cancer NOSSystem Organ Class: 100000017467Therapeutic area: Diseases [C] - Cancer [C04]
DrugsMitomycin C
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Patients with recurrent non-muscle invasive bladder cancer
- Sponsor
- Aarhus Universitet
- Enrollment
- 120
- Status
- Active, not recruiting
- Last Updated
- 8 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 120
- •F.1\.3 Elderly (\>\=65 years) yes
- •F.1\.3\.1 Number of subjects for this age range 120
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
Outcomes
Primary Outcomes
Not specified
Similar Trials
Completed
Phase 2
eo-adjuvant chemotherapy, cytoreductive surgery with hypethermic intraperitoneal chemotherapy for peritoneal carcinomatosis of colorectal origin.peritoneal cancerperitoneal carcinomatosis100346521001799110017998NL-OMON38114niversitair Medisch Centrum Groningen50
Active, not recruiting
Not Applicable
Pre treatment with chemotherapy followed by surgery and removal of all intra-abdominal tumor and intra-peritoneal heated chemotherapy for peritoneal metastastasized colorectal cancer.EUCTR2010-020787-37-NLniversitair Medisch Centrum Groningen10
Not yet recruiting
Not Applicable
A study comprising of chemotherapy and radiotherapy before the surgery of locally advanced rectal cancer.Health Condition 1: C20- Malignant neoplasm of rectumCTRI/2019/08/020847AIIMS New Delhi
Completed
Phase 4
Neoadjuvant Short-term Intensive Chemoresection Versus Standard Adjuvant Intravesical Instillations in NMIBCBladder CancerNCT03348969Jørgen Bjerggaard Jensen120
Completed
Phase 2
eo-Adjuvant Chemotherapy and Conservative Surgery in Cervical Cancer to Preserve Fertilitycervical cancercervical carcinoma10038594NL-OMON46384Antoni van Leeuwenhoek Ziekenhuis120