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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-000658-37-AT

Enrollment

124

Registered

2016-06-28

Start date

2016-08-02

Completion date

Unknown

Last updated

2018-09-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urothelial carcinoma of the urinary bladder MedDRA version: 19.0 Level: LLT Classification code 10046714 Term: Urothelial carcinoma bladder System Organ Class: 100000004864

Interventions

Trade Name: Gemcitabin Hospira Pharmaceutical Form: Infusion INN or Proposed INN: GEMCITABINE CAS Number: 95058-81-4 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concent

Eligibility

Sex/Gender

All

Inclusion criteria

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 50 mL/min · Adequate hematopoietic function, with WBC >3.0, Hb >9, and platelets >100,000. · Adequate hepatic function, with bilirubin =65 years) yes F.1.3.1 Number of subjects for this age range 24

Exclusion criteria

Exclusion criteria: please refer to Inclusion criteria

Design outcomes

Primary

Measure	Time frame
Main Objective: To compare GC and dose-dense MVAC in the neo-adjuvant setting for subjects with muscle-invasive urothelial carcinoma with respect to the rate of unacceptable toxicity: grade 3 or 4 mucositis or renal toxicity, grade 3 or 4 thrombocytopenia with bleeding, grade 2 neuropathy or death due to treatment in a phase II clinical trial. To compare GC and dose-dense MVAC in the neo-adjuvant setting for subjects with muscle-invasive urothelial carcinoma with respect to the pT0 rate at radical cystectomy and disease recurrence.;Secondary Objective: To evaluate select molecular markers to determine whether: A) They are associated with rates of disease recurrence associated with either treatment (RRM1, MDR1, BRCA1, ERCC1, XPD. topoisomerase II, p53) B) They can identify patients at higher risk for treatment-related toxicity. (CDA, XPD, GSTP-1, ERCC1);Primary end point(s): The primary endpoint of the trial will be toxicity, using a design that will allow for early stopping if a significant imbalance in unacceptable toxicity is identified. Unacceptable toxicity will be defined as grade 3 or 4 mucositis or renal toxicity, grade 3 or 4 thrombocytopenia with bleeding, grade 2 neuropathy (most common causes for treatment delays or early cessation) or death due to treatment.;Timepoint(s) of evaluation of this end point: after completion of last treatment cycle	—

Measure

Time frame

Main Objective: To compare GC and dose-dense MVAC in the neo-adjuvant setting for subjects with muscle-invasive urothelial carcinoma with respect to the rate of unacceptable toxicity: grade 3 or 4 mucositis or renal toxicity, grade 3 or 4 thrombocytopenia with bleeding, grade 2 neuropathy or death due to treatment in a phase II clinical trial. To compare GC and dose-dense MVAC in the neo-adjuvant setting for subjects with muscle-invasive urothelial carcinoma with respect to the pT0 rate at radical cystectomy and disease recurrence.;Secondary Objective: To evaluate select molecular markers to determine whether: A) They are associated with rates of disease recurrence associated with either treatment (RRM1, MDR1, BRCA1, ERCC1, XPD. topoisomerase II, p53) B) They can identify patients at higher risk for treatment-related toxicity. (CDA, XPD, GSTP-1, ERCC1);Primary end point(s): The primary endpoint of the trial will be toxicity, using a design that will allow for early stopping if a significant imbalance in unacceptable toxicity is identified. Unacceptable toxicity will be defined as grade 3 or 4 mucositis or renal toxicity, grade 3 or 4 thrombocytopenia with bleeding, grade 2 neuropathy (most common causes for treatment delays or early cessation) or death due to treatment.;Timepoint(s) of evaluation of this end point: after completion of last treatment cycle

—

Secondary

Measure	Time frame
Secondary end point(s): rate of disease recurrence at 3 years;Timepoint(s) of evaluation of this end point: within 3 years as of last treatment cycle	—

Countries

Austria

Contacts

Public ContactAgnieszka

Medizinische Universität Wien

agnieszka.maj-hes@meduniwien.ac.at004314040026150

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026