Aggressive Thoracic Radiotherapy for Stage Ⅳ Non Small Cell Lung Cancer

Study Overview
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Brief Summary
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This phase II trial studies the safety and efficacy of aggressive thoracic radiotherapy in treating patients with non-small cell lung cancer that has not progressed after the first line systemic therapy. In this trial, patients with stage Ⅳ non small cell lung cancer who did not progress after first line systemic therapy will receive the aggressive thoracic radiotherapy, and the safety and efficacy of aggressive thoracic radiotherapy will be evaluated. The primary end points of the study are overall survival (OS), the secondary end points are local control rate, local progression free survival(LPFS), PFS, and toxicity and quality of life(QOL).

Official Title
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The Efficacy and Toxicity of Aggressive Thoracic Radiotherapy for Stage Ⅳ Non-Small Cell Lung Cancer Patients With Controlled Extrathoracic Disease

Conditions
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Carcinoma, Non-Small-Cell Lung, Stage IV, Thoracic Radiotherapy

Intervention / Treatment
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* Radiation: Aggressive Thoracic Radiotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: histologically or cytologically confirmed NSCLC stage IV disease no progression after first line systemic therapy 18 to 80 years of age Karnofsky performance status(KPS) score ≥70% no contraindications to radiation therapy presumed ability to tolerate thoracic radiation therapy to a BED≥53Gy Exclusion Criteria: a history of thoracic surgery, radiation therapy, or more than first line chemotherapy pregnancy or lactation at the time of enrollment previous malignancy or other concomitant malignant disease

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm-R<br>patients in this arm will receive aggressive thoracic radiotherapy. | Radiation: Aggressive Thoracic Radiotherapy<br>* The target of the radiotherapy includes primary tumor and the locoregional positive lymph nodes, with a dose(BED)≥53Gray(Gy)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| OS | overall survival | two years after the beginning of first line systemic therapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LPFS | local progression free survival | 1 year after the beginning of first line systemic therapy | 
| PFS | progression free survival | 1 year after the beginning of first line systemic therapy | 
| toxicity related to the radiotherapy | assess according to the National Cancer Institute-Common Terminology Criteria for Adverse Events 3.0 | from the beginning of radiotherapy to the 3 month after the completion of radiotherapy |