Clinical trial NCT02584699: Study of Stereotactic Ablative Radiotherapy (SABR) in Elderly Stage I NSCLC
Official title: Phase II Study of Stereotactic Ablative Radiotherapy in Elderly Patients With Stage I Non-Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Non-Small Cell Lung Cancer
Lead sponsor: ChineseAMS
Sponsor class: UNKNOWN
First posted: 2015-10-23
Enrollment: 40
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Local regional progression free survival
timeFrame: 2 year
Secondary outcomes:
measure: Objective response rate
timeFrame: 1 month after RT
measure: Progression free survival
timeFrame: 2 year
measure: Overall survival
timeFrame: 2 year
measure: Grade ≥ 2 radiation induced normal tissue toxicity
timeFrame: 1 year
measure: Questionnaire on quality of life
timeFrame: 2 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Cancer Hospital/Institute, Chinese Academy of Medical Sciences
state: Beijing
Study officials:
affiliation: Cancer Hospital/Institute, Chinese Academy of Medical Sciences
name: Jingbo Wang, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Havlik 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.
citation: Yang 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.
citation: Wingo 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.
citation: Raz 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.
citation: Rowell 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.
citation: Dosoretz 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.
citation: Timmerman 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.
citation: Senthi S, Lagerwaard FJ, Haasbeek CJ, Slotman BJ, Senan S. Patterns of disease recurrence after stereotactic ablative radiotherapy for early stage non-small-cell lung cancer: a retrospective analysis. Lancet Oncol. 2012 Aug;13(8):802-9. doi: 10.1016/S1470-2045(12)70242-5. Epub 2012 Jun 22.