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

NCT05934461 | Completed

• 1 other identifier: Z-G20221781
• Study Type: observational
• Target: 48
• Locations: 0 countries
• Sites: N/A

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.

Conditions

The Primary Study Metric is Progression-free Survival (PFS)

Outcome Measures

Primary Outcomes (1)

• progression-free survival (PFS)

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

  2 years

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Laibin People's Hospital: lead

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Director of the Department of Oncology

Study Record Dates

• First Submitted: June 28, 2023
• First Posted: July 7, 2023
• Study Start: December 1, 2014
• Primary Completion: December 1, 2022
• Study Completion: June 1, 2023
• Last Updated: July 7, 2023

Record last verified: 2022-12