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
1 other identifier
interventional
40
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 nonsmall-cell-lung-cancer
Started Jul 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2015
CompletedFirst Submitted
Initial submission to the registry
August 13, 2015
CompletedFirst Posted
Study publicly available on registry
October 23, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2018
CompletedOctober 23, 2015
October 1, 2015
3 years
August 13, 2015
October 21, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (5)
Objective response rate
1 month after RT
Progression free survival
2 year
Overall survival
2 year
Grade ≥ 2 radiation induced normal tissue toxicity
1 year
Questionnaire on quality of life
2 year
Study Arms (1)
SABR
EXPERIMENTALSABR group includes patients receiving pre-identified fractionated Stereotactic Ablative Radiotherapy (SABR)
Interventions
Six Gy irradiation per fraction times 12 fractionations, resulting a total dose of 72Gy
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Luhua Wanglead
Study Sites (1)
Cancer Hospital/Institute, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021, China
Related Publications (8)
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.
PMID: 8087777BACKGROUNDYang 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: 21108881BACKGROUNDWingo 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: 12784323BACKGROUNDRaz 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: 17505036BACKGROUNDRowell 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: 11462066BACKGROUNDDosoretz 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: 8226142BACKGROUNDTimmerman 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.
PMID: 20233825BACKGROUNDSenthi 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.
PMID: 22727222BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jingbo Wang, Dr.
Cancer Hospital/Institute, Chinese Academy of Medical Sciences
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- UNKNOWN
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Deputy president, Cancer Hospital, Chinese Academy of Medical Sciences
Study Record Dates
First Submitted
August 13, 2015
First Posted
October 23, 2015
Study Start
July 1, 2015
Primary Completion
July 1, 2018
Study Completion
July 1, 2018
Last Updated
October 23, 2015
Record last verified: 2015-10