Clinical trial · Interventional
Study of Stereotactic Ablative Radiotherapy (SABR) in Elderly Stage I NSCLC
Phase II Study of Stereotactic Ablative Radiotherapy in Elderly Patients With Stage I Non-Small Cell Lung Cancer
NCT02584699CI-TRIAL-00019567unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Stereotactic Ablative Radiotherapy (SABR) | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- SABR
- description
- SABR group includes patients receiving pre-identified fractionated Stereotactic Ablative Radiotherapy (SABR)
- interventionNames
- Radiation: Stereotactic Ablative Radiotherapy (SABR)
Primary outcomes (1)
- measure
- Local regional progression free survival
- timeFrame
- 2 year
- description
- Duration between radiotherapy commencement and local progression, regional progression, death of cancer or last date of follow up.
Secondary outcomes (5)
- measure
- Objective response rate
- timeFrame
- 1 month after RT
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 70 Years
Show eligibility criteria text
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
References
Publications (8)
- BACKGROUNDHavlik RJ, Yancik R, Long S, Ries L, Edwards B. The National Institute on Aging and the National Cancer Institute SEER collaborative study on comorbidity and early diagnosis of cancer in the elderly. Cancer. 1994 Oct 1;74(7 Suppl):2101-6. doi: 10.1002/1097-0142(19941001)74:7+3.0.co;2-m. PMID 8087777
- BACKGROUNDYang L, Li L, Chen Y, Parkin DM. [Mortality time trends and the incidence and mortality estimation and projection for lung cancer in China]. Zhongguo Fei Ai Za Zhi. 2005 Aug 20;8(4):274-8. doi: 10.3779/j.issn.1009-3419.2005.04.05. Chinese. PMID 21108881
- BACKGROUNDWingo PA, Cardinez CJ, Landis SH, Greenlee RT, Ries LA, Anderson RN, Thun MJ. Long-term trends in cancer mortality in the United States, 1930-1998. Cancer. 2003 Jun 15;97(12 Suppl):3133-275. doi: 10.1002/cncr.11380. PMID 12784323
- BACKGROUNDRaz DJ, Zell JA, Ou SH, Gandara DR, Anton-Culver H, Jablons DM. Natural history of stage I non-small cell lung cancer: implications for early detection. Chest. 2007 Jul;132(1):193-9. doi: 10.1378/chest.06-3096. Epub 2007 May 15. PMID 17505036
- BACKGROUNDRowell NP, Williams CJ. Radical radiotherapy for stage I/II non-small cell lung cancer in patients not sufficiently fit for or declining surgery (medically inoperable): a systematic review. Thorax. 2001 Aug;56(8):628-38. doi: 10.1136/thorax.56.8.628. PMID 11462066
- BACKGROUNDDosoretz DE, Galmarini D, Rubenstein JH, Katin MJ, Blitzer PH, Salenius SA, Dosani RA, Rashid M, Mestas G, Hannan SE, et al. Local control in medically inoperable lung cancer: an analysis of its importance in outcome and factors determining the probability of tumor eradication. Int J Radiat Oncol Biol Phys. 1993 Oct 20;27(3):507-16. doi: 10.1016/0360-3016(93)90373-4. PMID 8226142
- BACKGROUNDTimmerman R, Paulus R, Galvin J, Michalski J, Straube W, Bradley J, Fakiris A, Bezjak A, Videtic G, Johnstone D, Fowler J, Gore E, Choy H. Stereotactic body radiation therapy for inoperable early stage lung cancer. JAMA. 2010 Mar 17;303(11):1070-6. doi: 10.1001/jama.2010.261.