RecruitingPhase 2NCT06257017

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

Surveillance of the Genetic Signature in Circulating Tumor DNA for Guiding Adjuvant Chemotherapy in Urothelial Carcinoma: A Pilot Randomized Controlled Trial


Sponsor

Yung NA

Enrollment

20 participants

Start Date

Feb 2, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

Urothelial carcinomas are one of the most commonly diagnosed cancers worldwide. Postoperative patients carry a poor prognosis with an estimated five-year disease-specific survival rate of 50%. To improve overall survival and reduce the recurrent risk, chemotherapy is recommended as a standard of care. However, currently in Hong Kong, neoadjuvant (preoperational) chemotherapy and adjuvant (postoperative) chemotherapy are not commonly or regularly provided due to the concern of the potential harm from both physicians and patients. Recently, genetic signature from circulating tumor DNA (ctDNA) is emerging as a pivotal biomarker for detecting caner in early stage and molecular residual disease (MRD). With strengths of non-invasive and superior sensitivity, ctDNA is hopefully to serve as a cancer-agnostic surrogate analyte for risk stratification of tumor recurrence, thereby guiding individually tailored treatment. Therefore, this study is proposed to exploratively assess the benefit of ctDNA-guided approach for postoperative adjuvant therapy.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is investigating whether genetic material from tumor cells circulating in the blood (called ctDNA) can help guide decisions about whether someone with bladder or urinary tract cancer needs additional chemotherapy after surgery. **You may be eligible if...** - You are between 18 and 70 years old - You are in generally good health (ECOG score 0 or 1) - You have had surgery to remove your bladder or urinary tract due to muscle-invasive urothelial carcinoma (a type of cancer involving the urinary lining) - Your cancer has not spread to distant parts of the body - Your blood counts, kidney, and liver function meet minimum requirements **You may NOT be eligible if...** - You received anti-cancer treatment within the past 3 weeks - You participated in another clinical trial within the past 28 days - You had another type of cancer in the past 5 years - Your kidney function is too low for chemotherapy (creatinine clearance below 50 mL/min) - You have significant hearing loss or poor bone marrow function that prevents chemotherapy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGgemcitabine

1,000 mg/m2 intravenous gemcitabine on day 1 and day 8

DRUGCisplatin

70 mg/m2 intravenous cisplatin (split into 2 doses on day 1 and day 8)


Locations(1)

Queen Mary Hospital

Hong Kong, Hong Kong, Hong Kong

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NCT06257017


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