DDR Genes Alteration and Response to Platinum-based Chemotherapy in Advanced Urothelial Cancer.
Trial Parameters
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Brief Summary
This study aims to prospectively observe whether certain alterations in some genes related to the DNA repair mechanism are related to better response to platinum-based chemotherapy used to treat metastatic bladder or urothelial cancers.
Eligibility Criteria
Inclusion Criteria: 1. Informed consent obtained before any study-specific procedures. Patients must be able to understand and be willing to sign a written informed consent. 2. Male or female patient ≥18 years of age. 3. Histological or cytological documentation of urothelial cancer. 4. Available tumor tissue for analysis 5. Measurable disease according to Response Evaluation Criteria in Solid Tumors criteria, version 1.1. 6. Eastern Cooperative Oncology Group performance status of ≤2. (Patients with ECOG PS of 2 were required to also meet the additional criteria: hemoglobin ≥10 g/dL, GFR ≥50mL/min, may not have NYHA class III heart failure). 7. Life expectancy of at least 6 months. 8. Eligible to standard chemotherapy with cisplatin or carboplatin + gemcitabine as per clinical practice. 9. Women of childbearing potential and men must agree to use adequate contraception since signing of the informed consent form until 180 days after the last dose of chemotherapy and 30 days after the l