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

Sponsor
Laibin People's Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT05934461
Collaborator
(none)
48
Enrollment
102
Actual Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    48 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    A Retrospective Study of Radiotherapy Combined With EGFR-TKI for Stage III EGFR Mutant Lung Cancer
    Actual Study Start Date :
    Dec 1, 2014
    Actual Primary Completion Date :
    Dec 1, 2022
    Actual Study Completion Date :
    Jun 1, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    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.

    Outcome Measures

    Primary Outcome Measures

    1. progression-free survival (PFS) [2 years]

      the time from treatment initiation to first documented progressive disease (PD) or time to death.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Laibin People's Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Liu Gang, Deputy Director of the Department of Oncology, Laibin People's Hospital
    ClinicalTrials.gov Identifier:
    NCT05934461
    Other Study ID Numbers:
    • Z-G20221781
    First Posted:
    Jul 7, 2023
    Last Update Posted:
    Jul 7, 2023
    Last Verified:
    Dec 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Disease Progression

    Study Results

    No Results Posted as of Jul 7, 2023