About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
aged 18-70 years old;
a score of ≤1 for the Eastern Cooperative Oncology Group (ECOG) Performance Status;
receiving radical cystectomy (with lymph node dissection) or nephroureterectomy;
histologically confirmed (surgical specimen) muscle invasive urothelial carcinoma, and the major histological type should be transitional cell carcinoma;
Disqualifiers
receiving any approved anti-cancer treatment within 3 weeks prior to study enrolment;
participation in another clinical trial with therapeutic intent within 28 days prior to enrolment;
suffering from malignancies other than urothelial carcinoma within 5 years prior to study enrolment;
conditions that contraindicate chemotherapy, such as renal impairment with creatinine clearance rate (CCr) <50 mL/min, hearing impairment, and inadequate marrow function;
Trial design
Parallel
Treatments tested in this trial
gemcitabine
Drug1,000 mg/m2 intravenous gemcitabine on day 1 and day 8
Cisplatin
Drug70 mg/m2 intravenous cisplatin (split into 2 doses on day 1 and day 8)
Treatment groups
Trial outcomes
Primary outcomes
the radiational disease-free survival (rDFS)
Secondary outcomes
Progression Free Survival (PFS)
time to recurrence
Overall Survival (OS)
ctDNA clearance rate in ctDNA(+) patients
Sponsors and contacts
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Yung NA
Lead sponsor
The University of Hong Kong
Sponsor institution
Pamela Youde Nethersole Eastern Hospital
Collaborator
Queen Mary Hospital, Hong Kong
Collaborator