Prospective, randomized phase III study of two intensified treatment groups [Methotrexate/Vinblastine/Adriamycin/Cisplatin (MVAC) vs. Gemcitabine/Cisplatin] in patients with inoperable or recurrent urothelial cancer
- Conditions
- urothelial cancerCancer - Bladder
- Registration Number
- ACTRN12610000845033
- Lead Sponsor
- Hellenic Cooperative Oncology Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 206
1. Histologically confirmed inoperable or recurrent transitional cell advanced urothelial cancer
2. Age of >18 years
3. Life expectancy > 3 months
4. No prior chemotherapy for advanced disease is allowed
5. Eastern Cooperative Oncology Group (ECOG) Performance Status: 0 or 1
6. Creatinine clearance > 50 ml/min (Cockroft Formula)
7. Absolute Neutrophil Count (ANC)>= 1,500 /Microlitre (microL), platelets>= 100,000 /microL, bilirubin and aspartate aminotransferase (AST)/alanine aminotransferase (ALT) <2N
8. Absence of cardiac failure. Patients previously treated with adriamycin are excluded from the study. Patients with cardiac disease should demonstrate a baseline left ventricular ejection fraction (LVEF) >50%
9. Signed Informed Consent
1.Other histology types of urothelial cancer. Mixed histology types mainly of transitional cell cancer are allowed.
2.History of other neoplasm within the 5 last years except for radically excised basal cell carcinoma of the skin or in situ carcinoma of the uterine cervix.
3.Prior adjuvant or neo-adjuvant chemotherapy containing adriamycin. Patients who received adjuvant or neo-adjuvant chemotherapy with Gemcitabine/Cisplatin or Gemcitabine/Carboplatin within the last 12 months are excluded.
4.Any active infection or other uncontrolled underlying condition (infection, cardiac arrythmia, diabetes mellitus)
5.Women of reproductive age should obtain a negative pregnancy test. All sexually active patients should take efficient contraceptive measures.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare survival time from randomization to death from any cause between the two intensified treatment groups (MVAC vs Gemcitabine/Cisplatin).[6 years after study initiation. This assessement will be done using clinical data records]
- Secondary Outcome Measures
Name Time Method