About this trial
For patients with lung cancer who have undergone tumor resection, early relapse significantly impacts survival. However, there are currently no reliable screening or imaging tools available to identify patients at risk of early relapse. To address this clinical challenge, many studies have focused on understanding the clinicopathologic characteristics associated with an increased risk of early relapse. Despite these efforts, we can identify patients at risk but cannot pinpoint which individuals will actually experience early relapse. Studies on adjuvant therapy have shown improved survival in cases of more advanced disease but have not demonstrated a reduction in early relapse rates.
In our preliminary analysis of previous study data, we observed that patients with a smaller reduction in circulating tumor cells (CTCs) within the first three days after surgery, followed by an increase on the third-day post-operation, are more likely to experience early relapse during regular monitoring. This pattern may be indicative of minimal residual disease. By combining trends in circulating tumor cell variations with pathologic characteristics, we aim to select patients for adjuvant therapy who are at high risk of developing early relapse.
The objective of our study is to employ screening based on circulating tumor cell dynamics and pathologic features to identify patients likely to experience early relapse and to assess the effectiveness of adjuvant therapy in these cases.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients who presented with resectable disease ( Clinical stage 1a to 3a)
Patients who received tumor resection
Disqualifiers
Pathologic stage greater than stage 3b or 4
Pathologic stage less than stage 1a1
Could not complete treatment course
Could not receive blood sampling for CTC (circulating tumor cell) or regular surveillance
Trial design
Single group
Treatments tested in this trial
Cisplatin based chemottherapy
Drugadjuvant therapy for high risk patient
Treatment groups
Trial outcomes
Primary outcomes
Accuracy of proposed relapse prediction model
1. Utilized the enrolled patients to testify proposed relapse prediction model 2. Calculated Positive prediction rate, Negative prediction rate, accuracy 3. Goal: high positive prediction rate, lower negative prediction rate, high accuracy
early relapse rate
1. adjuvant therapy based on proposed relapse prediction model * calculate the early relapse rate (relapse within 3 years) 2. utilized historical cohort as historical control (cohort that utilized to establish proposed relapse prediction model * adjuvant therapy based on TNM stage * calculate the early relapse rate (relapse within 3 years) * follow up Chest CT/ CTC in 3-month interval
Secondary outcomes
Overall surveival
Goal: difference of overall survival among patients with relapse risk 1. treatment based on proposed relapse prediction model 2. calculate the overall survival 3. utilized historical cohort as historical control ( cohort that utilized to establish proposed relapse prediction model * treatment based on TNM stage * calculate the overall survival rate
Sponsors and contacts
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Chang Gung Memorial Hospital
Lead sponsor
National Science and Technology Council
Collaborator