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

Luhua Wang

Status and phase: Unknown; Phase 2

Conditions: Non-Small Cell Lung Cancer

Treatments: Radiation: Stereotactic Ablative Radiotherapy (SABR)

Study type: Interventional

Funder types: Other

Identifiers

NCT02584699

33320140105

Details and patient eligibility

About

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).

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 70+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

SABR

Experimental group

Description:

SABR group includes patients receiving pre-identified fractionated Stereotactic Ablative Radiotherapy (SABR)

Treatment:

Radiation: Stereotactic Ablative Radiotherapy (SABR)