Study of Stereotactic Ablative Radiotherapy (SABR) in Elderly Stage I NSCLC

Study Overview
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Brief Summary
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This study aims to prospectively investigate the efficacy, toxicity and quality of life (QOF) of stereotactic ablative radiotherapy (SABR) using a moderate fractionation of 72 Gy/6 Gy/12 F (BED10 = 115 Gy) in a single arm of elderly ( ≥ 70) patients with stage I (2009 UICC) non-small cell lung cancer (NSCLC).

Detailed Description
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This study aims to prospectively investigate the local regional control, overall survival, treatment related toxicities and quality of life (QOF) of elderly stage I NSCLC patients receiving stereotactic ablative radiotherapy (SABR) with a moderate fractionation of 72 Gy/6 Gy/12 F (BED10 = 115 Gy). Patients' general characteristics, treatment modality, dose-volume histogram (DVH) parameters, toxicity profiling, quality of life, pattern of failure as well as survival time will be prospective recorded for the analysis.

Official Title
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Phase II Study of Stereotactic Ablative Radiotherapy in Elderly Patients With Stage I Non-Small Cell Lung Cancer

Conditions
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Non-Small Cell Lung Cancer

Intervention / Treatment
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* Radiation: Stereotactic Ablative Radiotherapy (SABR)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 70 Pathologically or cytologically confirmed NSCLC Stage T1- 2 N0M0 based on adequate workup Peripheral tumor Eastern Cooperative Oncology Group (ECOG) 0-1 Inoperable NSCLC Exclusion Criteria: Pathologically or cytologically confirmed SCLC Direct evidence of regional or distant metastasis Central tumor Past history of malignancy Past history of thoracic irradiation Past history of chemotherapy Past history of thoracic surgery Pure Bronchioalveolar adenocarcinoma Active systemic, pulmonary or pleural lung diseases Pulmonary infection

Ages Eligible for Study
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Minimum Age: 70 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: SABR<br>SABR group includes patients receiving pre-identified fractionated Stereotactic Ablative Radiotherapy (SABR) | Radiation: Stereotactic Ablative Radiotherapy (SABR)<br>* Six Gy irradiation per fraction times 12 fractionations, resulting a total dose of 72Gy<br>* Other names: Stereotactic body radiation therapy (SBRT);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Local regional progression free survival | Duration between radiotherapy commencement and local progression, regional progression, death of cancer or last date of follow up. | 2 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response rate | Tumor response to radiotherapy evaluated by RECIST 1.1 | 1 month after RT | 
| Progression free survival | Duration between radiotherapy commencement and any progression, death of cancer or last date of follow up. | 2 year | 
| Overall survival | Duration between radiotherapy commencement and any cause of death or last date of follow up. | 2 year | 
| Grade ≥ 2 radiation induced normal tissue toxicity | Incidence of radiation induced toxicities on lung, oesophagus, rib or chest wall pain assessed by CTCAE v 4.0 | 1 year | 
| Questionnaire on quality of life | Physical and psychologic status assessed by specific questionnaire | 2 year |