eoadjuvant chemotherapy with gemcitabine and cisplatin (GC) versus dose-dense methotrexate, vinblastine, doxorubicin and cisplatin (MVAC) in muscle-invasive urothelial carcinoma of the bladder

Phase 1

• Conditions: rothelial carcinoma of the urinary bladder; MedDRA version: 19.0Level: LLTClassification code 10046714Term: Urothelial carcinoma bladderSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2016-000658-37-AT
• Lead Sponsor: Medizinische Universität Wien

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-06-28
• Last Update Posted: 10 September 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 124

Inclusion Criteria

· Transitional cell carcinoma; may have papillary, squamous, or adenocarcinoma features provided the dominant histology is TCC. Small cell will not be permitted.
· Pathologic stage of T3, T4, or N+ without evidence of distant metastases
· Radical cystectomy/nephrectomy (for upper tract) within 90 days prior to
enrollment
· ECOG performance status 0 or 1
· Adequate renal function, with serum creatinine < institutional ULN or
measured 24-hour creatinine clearance >50 mL/min
· Adequate hematopoietic function, with WBC >3.0, Hb >9, and platelets
>100,000.
· Adequate hepatic function, with bilirubin <1.5x ULN (except for patients with
Gilbert’s) and AST/ALT < 3 x ULN
· Normal LV EF and no unstable angina
· No prior systemic therapy for UC (intravesical therapy is permitted)
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 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 24

Exclusion Criteria

please refer to Inclusion criteria

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified