Adjuvant Chemotherapy for High-Risk Pathologic Stage I Non-Squamous NSCLC

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2072 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-01-01

Study Completion Date

2025-06-01

Brief Summary

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Brief Summary The goal of this clinical trial is to evaluate the effect of postoperative adjuvant chemotherapy (ACT) in patients with stage I non-squamous non-small cell lung cancer (NSCLC) after curative resection.

The main questions it aims to answer are:

Does ACT improve recurrence-free survival (RFS) compared with observation alone?

Does ACT provide disease-free survival (DFS) benefit in this patient population?

Researchers will compare the adjuvant chemotherapy group with the observation group to see if chemotherapy reduces the risk of recurrence and improves survival outcomes.

Participants will:

Receive standard platinum-based adjuvant chemotherapy after surgery or undergo regular postoperative surveillance according to institutional guidelines.

Be followed at scheduled intervals with clinical assessments and imaging to monitor for recurrence and survival outcomes.

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Detailed Description

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Conditions

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Non-small Cell Lung Cancer Stage I

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Adjuvant chemotherapy

Adjuvant chemotheapy

Intervention Type DRUG

apply adjuvant chemotheapy

Postoperative Observation

No interventions assigned to this group

Interventions

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Adjuvant chemotheapy

apply adjuvant chemotheapy

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Patients must have histologically confirmed non-squamous NSCLC
2. Patients must be ≥18 years of age at the time of diagnosis
3. Pathological stage I disease (T1-2N0M0) according to the AJCC 8th edition (specify if applicable)
4. Patients must have undergone complete surgical resection (R0) with systematic lymph node dissection
5. Surgery performed between January 1, 2015 and December 31, 2019

Exclusion Criteria

1. Prior history of malignant tumors or presence of synchronous other primary malignancy
2. Multiple primary lung cancers diagnosed at baseline
3. Receipt of any neoadjuvant chemotherapy, radiotherapy, or targeted therapy
4. Perioperative death occurring within 30 days after surgery
5. Incomplete or missing clinical or pathological information
6. Loss to follow-up before the first scheduled surveillance assessment

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No