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

Non-Small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02584699
• Other study ID #: 33320140105
• Status: Recruiting
• Phase: Phase 2
• First received: August 13, 2015
• Last updated: October 21, 2015
• Start date: July 2015
• Est. completion date: July 2018

Study information

• Verified date: October 2015
• Source: Chinese Academy of Medical Sciences
• Contact: Jingbo Wang, Dr.
• Phone: 8610-87788503
• Email: wangjingbo303[@]yahoo.com
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: July 2018
• Est. primary completion date: July 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 70 Years and older

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Non-Small Cell Lung Cancer

Intervention

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

Locations

Country	Name	City	State
China	Cancer Hospital/Institute, Chinese Academy of Medical Sciences	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Luhua Wang

Country where clinical trial is conducted

China, 

References & Publications (8)

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. — View 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. — View 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. Epub 2007 May 15. — View 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. Review. — View 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. — View 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. — View 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. Erratum in: Cancer. 2005 Jun 15;103(12):2658. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Local regional progression free survival	Duration between radiotherapy commencement and local progression, regional progression, death of cancer or last date of follow up.	2 year	No
Secondary	Objective response rate	Tumor response to radiotherapy evaluated by RECIST 1.1	1 month after RT	No
Secondary	Progression free survival	Duration between radiotherapy commencement and any progression, death of cancer or last date of follow up.	2 year	No
Secondary	Overall survival	Duration between radiotherapy commencement and any cause of death or last date of follow up.	2 year	No
Secondary	Grade = 2 radiation induced normal tissue toxicity	Incidence of radiation induced toxicities on lung, oesophagus, rib or chest wall pain assessed by CTCAE v 4.0	1 year	Yes
Secondary	Questionnaire on quality of life	Physical and psychologic status assessed by specific questionnaire	2 year	No