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

Phase 2

• Conditions: Non-Small Cell Lung Cancer
• Interventions: Radiation: Stereotactic Ablative Radiotherapy (SABR)

• Registration Number: NCT02584699
• Lead Sponsor: Luhua Wang

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.

Study Timeline

• Study Start: 2015-07
• Study First Submitted: 2015-08-13
• Status Verified: 2015-10
• Study First Submitted QC: 2015-10-21
• Last Update Submitted: 2015-10-21
• Study First Posted: 2015-10-23
• Last Update Posted: 2015-10-23
• Primary Completion: 2018-07
• Study Completion: 2018-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Local regional progression free survival	2 year	Duration between radiotherapy commencement and local progression, regional progression, death of cancer or last date of follow up.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Cancer Hospital/Institute, Chinese Academy of Medical Sciences; 🇨🇳 Beijing, Beijing, China