Real-world Treatment Patterns and Clinical Outcomes in EGFR-mutant Unresectable Locally Advanced NSCLC

NCT ID: NCT04304638

Last Updated: 2020-03-11

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

UNKNOWN

Total Enrollment

450 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-03-31

Study Completion Date

2020-06-30

Brief Summary

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The investigators will obtain a cohort of patients from multiple large cancer centers in China and try to unravel the efficacy of "radiotherapy combined with EGFR-TKI", which may provide some evidences for the treatment of stage III-inoperable NSCLC.

Detailed Description

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The frequency of EGFR mutations in patients with stage III inoperable adenocarcinoma or non-squamous cell carcinoma is 17-31%, which is relatively low. Compared to patients with EGFR wild type, the efficacy of radiotherapy or chemo-radiotherapy may be different in EGFR mutant patients. Some small sample studies showed, compared with patients with EGFR wild type, patients with EGFR mutations have a lower risk of local recurrence and a higher risk of distant metastasis under the standard treatment for stage III lung cancer, which demonstrate the strength of systemic therapy may help. Radiotherapy combined with EGFR-Tyrosine kinase inhibitors(TKI) is a feasible treatment strategy. In view of the low mutation frequency and few prospective research results, the investigators try to explore the survival differences of three treatment strategies used in clinical practice based on the real world data. The investigators will obtain a cohort of patients from multiple large cancer centers in China and try to unravel the efficacy of "radiotherapy combined with EGFR-TKI", which may provide some evidences for the further study.

Conditions

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Non Small Cell Lung Cancer Stage III Non-small-cell Lung Cancer EGFR Mutation-Related Tumors

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Radiation(Chemo-radiation)

Patients in this group had been treated with definitive radiation/Chemo-radiation followed by no treatment until progression.

radiation or chemo-radiation

Intervention Type RADIATION

standard treatment for stage III lung cancer

radiation+EGFR-TKI

Patients in this group had been treated with one of the following three ways: 1) definitive radiation and concurrent EGFR-TKI followed by EGFR-TKI till progression; 2) EGFR-TKI followed by radiation and continue TKI util progression; 3) radiation and TKI thereafter until progression.

radiation or chemo-radiation

Intervention Type RADIATION

standard treatment for stage III lung cancer

EGFR-TKI Inhibitor

Intervention Type DRUG

the standard treatment for stage IV lung cancer with EGFR mutation

EGFR-TKI

Patients in this group had been treated with EGFR-TKI without any other treatment until progression.

EGFR-TKI Inhibitor

Intervention Type DRUG

the standard treatment for stage IV lung cancer with EGFR mutation

Interventions

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radiation or chemo-radiation

standard treatment for stage III lung cancer

Intervention Type RADIATION

EGFR-TKI Inhibitor

the standard treatment for stage IV lung cancer with EGFR mutation

Intervention Type DRUG

Other Intervention Names

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EGFR-TKI alone

Eligibility Criteria

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Inclusion Criteria

* histologically confirmed NSCLC with adenocarcinoma
* stage III (AJCC 7th edition)
* inoperable or refuse surgery
* EGFR-TKI mutation, specimen from tissue or blood

Exclusion Criteria

* the pathology was not adenocarcinoma
* stage I,II and IV
* anaplastic lymphoma kinase (ALK) rearrangement
* no follow-up data achievable
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chinese Academy of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Luhua Wang

Principal Investigator, Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Luhua Wang, MD

Role: PRINCIPAL_INVESTIGATOR

Cancer center of Chinese Academy of Medical Sciences

Central Contacts

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Luhua Wang, MD

Role: CONTACT

01087788799

Nan Bi, MD,PhD

Role: CONTACT

01087788799

Other Identifiers

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CAMS19/216-2000

Identifier Type: -

Identifier Source: org_study_id

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