A Retrospective Study of Radiotherapy Combined With EGFR-TKI for Stage III EGFR Mutant Lung Cancer

June 28, 2023 updated by: Liu Gang, Laibin People's Hospital
Objective: To investigate the efficacy and safety of radiotherapy combined with EGFR-KI in the treatment of stage III EGFR mutant lung cancer. Methods: Stage III EGFR mutant lung cancer cases who underwent radiotherapy combined with EGFR-TKI from December 2014 to December 2022 at the People's Hospital of Laibin, the First People's Hospital of Yulin, the Affiliated Hospital of Guilin Medical College, and the Park East Hospital of Guangxi Medical University Kaiyuan were collected, and the primary index of the study was progression-free survival (PFS), and the secondary indexes were objective remission rate, overall survival, recurrence pattern, and adverse events. Survival analysis was performed using the Kaplan-Meier method with Log rank test for univariate analysis and Cox proportional risk model for multifactorial analysis of prognosis.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
48

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

patients diagnosed with lung cancer by pathology,genetic testing for EGFR mutation type

Description

Inclusion Criteria:

  • ①patients diagnosed with lung cancer by pathology; ②genetic testing for EGFR mutation type; ③compliance with the international eighth edition of lung cancer TNM stage IIIA-IIIC; ④treatment modality of radiotherapy + targeted therapy. ⑤Eastern Cooperative Oncology Group (ECOG) physical status score ≤ 2

Exclusion Criteria:

  • (1) those who underwent surgery; (2) those who received chemotherapy. (3) Combination of other serious diseases that affect survival.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
an open-label, multiinstitutional, single-arm retrospective study
Three-dimensional conformal radiotherapy (3DCRT) or intensity-modulated conformal radiotherapy (IMRT) at a prescribed dose of 54-66 Gy/27-33 f. The combined TKI includes gefitinib, erlotinib, erlotinib, oseltinib, and ametinib. The specific uses are: gefitinib 250 mg orally once daily; erlotinib 125 mg orally three times daily; erlotinib 150 mg orally once daily; oseltinib 80 mg orally once daily; ametinib 110 mg orally once daily. TKI is taken until disease progression or intolerability.
RT+C
Three-dimensional conformal radiotherapy (3DCRT) or intensity-modulated conformal radiotherapy (IMRT) at a prescribed dose of 54-66 Gy/27-33 f. The combined TKI includes gefitinib, erlotinib, erlotinib, oseltinib, and ametinib. The specific uses are: gefitinib 250 mg orally once daily; erlotinib 125 mg orally three times daily; erlotinib 150 mg orally once daily; oseltinib 80 mg orally once daily; ametinib 110 mg orally once daily. TKI is taken until disease progression or intolerability.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
progression-free survival (PFS)
Time Frame: 2 years
the time from treatment initiation to first documented progressive disease (PD) or time to death.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Laibin People's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 28, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 28, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 7, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 7, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 28, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Z-G20221781

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings