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

Overview

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 Title of Study: “Phase II Study of Stereotactic Ablative Radiotherapy in Elderly Patients With Stage I Non-Small Cell Lung Cancer”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: July 2018

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

  • Radiation: Stereotactic Ablative Radiotherapy (SABR)
    • Six Gy irradiation per fraction times 12 fractionations, resulting a total dose of 72Gy

Arms, Groups and Cohorts

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

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • Objective response rate
    • Time Frame: 1 month after RT
    • Tumor response to radiotherapy evaluated by RECIST 1.1
  • Progression free survival
    • Time Frame: 2 year
    • Duration between radiotherapy commencement and any progression, death of cancer or last date of follow up.
  • Overall survival
    • Time Frame: 2 year
    • Duration between radiotherapy commencement and any cause of death or last date of follow up.
  • Grade ≥ 2 radiation induced normal tissue toxicity
    • Time Frame: 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
    • Time Frame: 2 year
    • Physical and psychologic status assessed by specific questionnaire

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 70 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Luhua Wang
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Luhua Wang, Deputy president, Cancer Hospital, Chinese Academy of Medical Sciences – Chinese Academy of Medical Sciences
  • Overall Official(s)
    • Jingbo Wang, Dr., Principal Investigator, Cancer Hospital/Institute, Chinese Academy of Medical Sciences
  • Overall Contact(s)
    • Jingbo Wang, Dr., 8610-87788503, wangjingbo303@yahoo.com

References

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.

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.

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. Erratum in: Cancer. 2005 Jun 15;103(12):2658.

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. Epub 2007 May 15.

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. Review.

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.

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.

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.

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