Surveillance of the Genetic Signature in Circulating Tumor DNA for Guiding Adjuvant Chemotherapy in Urothelial Carcinoma

Launched by YUNG NA · Feb 5, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a new way to guide chemotherapy treatment for patients with muscle-invasive bladder cancer after surgery. Researchers want to see if analyzing a specific genetic signature from circulating tumor DNA (ctDNA) in the blood can help doctors better decide if and when patients should receive additional chemotherapy. This approach could lead to more personalized treatment plans, potentially improving survival rates and reducing the chances of the cancer coming back.

To participate in this study, patients should be between 18 and 70 years old and have had surgery for their bladder cancer, with no remaining cancer detected in their body. They also need to be in good overall health, as determined by specific blood tests. If eligible, participants will undergo testing to check their ctDNA and may receive chemotherapy based on those results. The trial is currently recruiting patients, and participants will be closely monitored throughout the study. This research is important because it could change how doctors treat bladder cancer and improve outcomes for patients.

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ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. aged 18-70 years old;
• • 2. a score of ≤1 for the Eastern Cooperative Oncology Group (ECOG) Performance Status;
• • 3. receiving radical cystectomy (with lymph node dissection) or nephroureterectomy;
• • 4. histologically confirmed (surgical specimen) muscle invasive urothelial carcinoma, and the major histological type should be transitional cell carcinoma;
• • 5. Classification of tumour, node and metastasis (TNM): pT2-4a N0-2M0;
• • 6. absence of microscopic (i.e., positive margin) or gross residual of the tumor (R0 resection) and absence of metastasis, confirmed by a negative CT or MRI scan of pelvis, abdomen and chest within 4 weeks prior to enrolment;
• 7. adequate hematologic and end-organ function, defined by the following laboratory results obtained within 28 days prior to the first study treatment:
• • ANC≥1500 cells/μL (without granulocyte colony-stimulating factor support within 2 weeks prior to Cycle 1, Day 1)
• • WBC counts \> 2500 cells/μL
• • Lymphocyte count ≥ 300 cells/μL
• • Platelet count ≥ 100,000 cells/μL (without transfusion within 2 weeks prior to Cycle 1, Day 1)
• • Hemoglobin ≥ 9.0 g/dL
• • AST, ALT, and alkaline phosphatase ≤ 2.5 × the upper limit of normal (ULN),
• • PTT ≤ 1.5 × ULN
• • PT ≤ 1.5 × ULN or INR \< 1.7
• • Calculated creatinine clearance ≥ 30 mL/min (Cockcroft-Gault formula)
• • 8. able to understand and provide written informed consent, and agree to receive the treatment arrangement and study procedures stated in the informed consent
• Exclusion Criteria:
• • 1. receiving any approved anti-cancer treatment within 3 weeks prior to study enrolment;
• • 2. participation in another clinical trial with therapeutic intent within 28 days prior to enrolment;
• • 3. suffering from malignancies other than urothelial carcinoma within 5 years prior to study enrolment;
• • 4. conditions that contraindicate chemotherapy, such as renal impairment with creatinine clearance rate (CCr) \<50 mL/min, hearing impairment, and inadequate marrow function;
• • 5. anaphylactic or hypersensitivity reactions or other contraindication to cisplatin and gemcitabine;
• • 6. active or uncontrolled infections, including human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV), or tuberculosis;
• • 7. pregnancy or breastfeeding.