Perioperative Treatment Outcomes of Early NSCLC

• Conditions: NSCLC

• Registration Number: NCT06610240
• Lead Sponsor: Shanghai Chest Hospital

Brief Summary

This is an observational study evaluating the clinical characteristics, treatment patterns, and clinical outcomes of perioperative NSCLC patients receiving different treatment strategies. According to the inclusion and exclusion criteria, perioperative NSCLC patients admitted to the study center from January 1, 2020, to one year after the study initiation will be retrospectively screened and collected.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-09-11
• Study First Submitted QC: 2024-09-23
• Study First Posted: 2024-09-24
• Status Verified: 2024-11
• Study Start: 2024-11-01
• Last Update Submitted: 2024-11-10
• Last Update Posted: 2024-11-13
• Primary Completion: 2025-05-31
• Study Completion: 2025-10-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• Stage I-III NSCLC patients confirmed by histological or cytological examination based on the 8th edition of the AJCC staging system.
• Patients who have undergone radical lung cancer surgery.
• Patients who have received neoadjuvant treatment before radical lung cancer surgery, including chemotherapy, targeted therapy, or immunotherapy both alone or combined.

Exclusion Criteria

• Patients with other previous malignancies, except those who achieved complete remission at least two years before radical lung cancer surgery and did not require additional treatment.
• Patients with incomplete key baseline and treatment information，including clinical stage, pathological type, neoadjuvant treatment, pathological response, imaging response after neoadjuvant.
• Patients included in anti-tumor drug intervention or unblinded clinical trials, in which the treatment being administered is unknown.
• Prior surgery, radiotherapy or systemic therapy for NSCLC, including radiofrequency ablation, etc.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
event-free survival	From date of diagnosis until the date of first documented progression, recurrence or date of death from any cause, whichever came first, assessed up to 36 months	the time from randomization to any progression of disease precluding surgery, progression or recurrence of disease after surgery, progression of disease in the absence of surgery, or death from any cause;
overall survival	From date of diagnosis until the date of death from any cause, whichever came first, assessed up to 60 months	from diagnosis to death

Secondary Outcome Measures

Name	Time	Method
R0 resection rate	usually 1 week after surgery	margin negative resection
major pathological response	usually 1 week after surgery	viable tumor cell less than 10%
p-CR	usually 1 week after surgery	no viable tumor cells was observed

Trial Locations

Locations (1)

Zhong Hua; 🇨🇳 Shanghai, Shanghai, China