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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorYung NA

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • gemcitabine

    Drug

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

  • Cisplatin

    Drug

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

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: Gemcitabine plus cisplatin chemotherapy arm (GC arm)Experimental treatment 2 interventions
Group B: Standard management arm (SM arm)Other 2 interventions

Trial outcomes

Primary outcomes

1

the radiational disease-free survival (rDFS)

Time frame
1 year

Secondary outcomes

1

Progression Free Survival (PFS)

time to recurrence

Time frame
1 year
2

Overall Survival (OS)

Time frame
5 year
3

ctDNA clearance rate in ctDNA(+) patients

Time frame
1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Yung NA

Lead sponsor

The University of Hong Kong

Sponsor institution

Pamela Youde Nethersole Eastern Hospital

Collaborator

Queen Mary Hospital, Hong Kong

Collaborator