Actively Recruiting
DDR Genes Alteration and Response to Platinum-based Chemotherapy in Advanced Urothelial Cancer.
Led by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Updated on 2025-02-11
135
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
DDR Genes Alteration and Response to Platinum-based Chemotherapy in Advanced Urothelial Cancer.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provided informed consent and able to understand study procedures
- Male or female 18 years of age or older
- Confirmed diagnosis of urothelial cancer by tissue examination
- Available tumor tissue for genetic analysis
- Measurable disease by standard criteria (RECIST v1.1)
- Eastern Cooperative Oncology Group performance status of 0, 1, or 2 (with additional criteria for PS 2)
- Life expectancy of at least 6 months
- Eligible for standard platinum plus gemcitabine chemotherapy
- Willing to use adequate contraception during and after treatment as instructed
- Adequate bone marrow, liver, and kidney function based on recent lab tests
You will not qualify if you...
- Prior treatment for metastatic or locally advanced urothelial cancer
- Adjuvant therapy within 1 year before metastatic diagnosis
- Previous immunotherapy treatment
- Other active cancers within 3 years except certain treated cancers
- Major surgery or significant injury within 28 days before study medication
- Pregnancy or breastfeeding
- Serious heart conditions including severe heart failure, unstable angina, recent heart attack, or certain arrhythmias
- Uncontrolled high blood pressure
- Recent blood clot events within 4 months
- Active infection above mild severity
- Known HIV or chronic hepatitis B or C infection
- Autoimmune diseases that prevent immunotherapy use
- Seizure disorders requiring medication
- Symptomatic brain or meningeal tumors unless stable and treated
- History of organ transplant
- Recent serious bleeding events or bleeding disorders
- Non-healing wounds or fractures
- Kidney failure requiring dialysis
- Any unstable medical condition threatening safety or study compliance
- Live vaccine received within 30 days before study start
- Participation in another clinical trial at enrollment
AI-Screening
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Trial Site Locations
Total: 1 location
1
Fondazione Policlinico Universitario A. Gemelli IRCCS
Rome, Italy, 00168
Actively Recruiting
Research Team
R
Roberto Iacovelli, Prof
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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