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

NCT ID: NCT02584699

Last Updated: 2015-10-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Study Completion Date

2018-07-31

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Non-Small Cell Lung Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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SABR

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

Group Type EXPERIMENTAL

Stereotactic Ablative Radiotherapy (SABR)

Intervention Type RADIATION

Six Gy irradiation per fraction times 12 fractionations, resulting a total dose of 72Gy

Interventions

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Stereotactic Ablative Radiotherapy (SABR)

Six Gy irradiation per fraction times 12 fractionations, resulting a total dose of 72Gy

Intervention Type RADIATION

Other Intervention Names

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Stereotactic body radiation therapy (SBRT)

Eligibility Criteria

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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
Minimum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Luhua Wang

UNKNOWN

Sponsor Role lead

Responsible Party

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Luhua Wang

Deputy president, Cancer Hospital, Chinese Academy of Medical Sciences

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Jingbo Wang, Dr.

Role: PRINCIPAL_INVESTIGATOR

Cancer Hospital/Institute, Chinese Academy of Medical Sciences

Locations

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Cancer Hospital/Institute, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Jingbo Wang, Dr.

Role: CONTACT

8610-87788503

Luhua Wang, Dr.

Role: CONTACT

8610-87788799

Facility Contacts

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Jingbo Wang, Dr.

Role: primary

8610-87788503

Luhua Wang, Dr.

Role: backup

8610-87788799

References

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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.

Reference Type BACKGROUND
PMID: 8087777 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21108881 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12784323 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17505036 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11462066 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8226142 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20233825 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22727222 (View on PubMed)

Other Identifiers

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33320140105

Identifier Type: -

Identifier Source: org_study_id

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