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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SABR | Experimental | SABR group includes patients receiving pre-identified fractionated Stereotactic Ablative Radiotherapy (SABR) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stereotactic Ablative Radiotherapy (SABR) | Radiation | Six Gy irradiation per fraction times 12 fractionations, resulting a total dose of 72Gy |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate | Tumor response to radiotherapy evaluated by RECIST 1.1 | 1 month after RT |
| Progression free survival | Duration between radiotherapy commencement and any progression, death of cancer or last date of follow up. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jingbo Wang, Dr. | Contact | 8610-87788503 | wangjingbo303@yahoo.com | |
| Luhua Wang, Dr. | Contact | 8610-87788799 | wlhwq@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Jingbo Wang, Dr. | Cancer Hospital/Institute, Chinese Academy of Medical Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Hospital/Institute, Chinese Academy of Medical Sciences | Recruiting | Beijing | Beijing Municipality | 100021 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 8087777 | Background | 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. | |
| 21108881 | Background |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| D016634 | Radiosurgery |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D013238 | Stereotaxic Techniques |
| D019635 | Neurosurgical Procedures |
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| 2 year |
| Overall survival | Duration between radiotherapy commencement and any cause of death or last date of follow up. | 2 year |
| 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 |
| Questionnaire on quality of life | Physical and psychologic status assessed by specific questionnaire | 2 year |
| 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. |
| 12784323 | Background | 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. |
| 17505036 | Background | 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. |
| 11462066 | Background | 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. |
| 8226142 | Background | 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. |
| 20233825 | Background | 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. |
| 22727222 | Background | 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. |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D013514 |
| Surgical Procedures, Operative |
| D008919 | Investigative Techniques |