Phase II Study of Stereotactic Ablative Radiotherapy in Elderly Patients With Stage I Non-Small Cell Lung Cancer
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Non-Small Cell Lung Cancer
- Sponsor
- Luhua Wang
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Local regional progression free survival
- Last Updated
- 10 years ago
Overview
Brief Summary
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
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.
Investigators
Luhua Wang
Deputy president, Cancer Hospital, Chinese Academy of Medical Sciences
Chinese Academy of Medical Sciences
Eligibility Criteria
Inclusion Criteria
- •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
Outcomes
Primary Outcomes
Local regional progression free survival
Time Frame: 2 year
Duration between radiotherapy commencement and local progression, regional progression, death of cancer or last date of follow up.
Secondary Outcomes
- Progression free survival(2 year)
- Overall survival(2 year)
- Grade ≥ 2 radiation induced normal tissue toxicity(1 year)
- Objective response rate(1 month after RT)
- Questionnaire on quality of life(2 year)