Perioperative Treatment Outcomes of Early NSCLC

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.

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Key information

Conditions

NSCLC Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Sex eligibility

All sexes

Study type

Observational

Primary location

Zhong Hua

Shanghai, Shanghai Municipality, 200030, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

event-free survival

Time frame: 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

Time frame: 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 outcomes

R0 resection rate

Time frame: usually 1 week after surgery

margin negative resection
major pathological response

Time frame: usually 1 week after surgery

viable tumor cell less than 10%
p-CR

Time frame: usually 1 week after surgery

no viable tumor cells was observed

Sponsors and collaborators

Lead sponsor

Shanghai Chest Hospital

Other

Registry information

Official study title

Perioperative Treatment Patterns and Clinical Outcomes in Early-Stage Non-Small Cell Lung Cancer: a Real-World Observational Study

Acronym: Peri-R

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2025
First posted: Sep 24, 2024
Registry last updated: Nov 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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