Non-Small Cell Lung Cancer
Conditions
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.
Interventions
Six Gy irradiation per fraction times 12 fractionations, resulting a total dose of 72Gy
Sponsors
Luhua Wang
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate | 1 month after RT | Tumor response to radiotherapy evaluated by RECIST 1.1 |
| 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 |
| Questionnaire on quality of life | 2 year | Physical and psychologic status assessed by specific questionnaire |
Countries
China
Contacts
Primary ContactJingbo Wang, Dr.
Backup ContactLuhua Wang, Dr.
Outcome results
None listed