search
Back to results

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

Primary Purpose

Non-Small Cell Lung Cancer

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Stereotactic Ablative Radiotherapy (SABR)
Sponsored by
Luhua Wang
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Small Cell Lung Cancer

Eligibility Criteria

70 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cancer Hospital/Institute, Chinese Academy of Medical SciencesRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SABR

Arm Description

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

Outcomes

Primary Outcome Measures

Local regional progression free survival
Duration between radiotherapy commencement and local progression, regional progression, death of cancer or last date of follow up.

Secondary Outcome Measures

Objective response rate
Tumor response to radiotherapy evaluated by RECIST 1.1
Progression free survival
Duration between radiotherapy commencement and any progression, death of cancer or last date of follow up.
Overall survival
Duration between radiotherapy commencement and any cause of death or last date of follow up.
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
Questionnaire on quality of life
Physical and psychologic status assessed by specific questionnaire

Full Information

First Posted
August 13, 2015
Last Updated
October 21, 2015
Sponsor
Luhua Wang
search

1. Study Identification

Unique Protocol Identification Number
NCT02584699
Brief Title
Study of Stereotactic Ablative Radiotherapy (SABR) in Elderly Stage I NSCLC
Official Title
Phase II Study of Stereotactic Ablative Radiotherapy in Elderly Patients With Stage I Non-Small Cell Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Unknown status
Study Start Date
July 2015 (undefined)
Primary Completion Date
July 2018 (Anticipated)
Study Completion Date
July 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Luhua Wang

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Small Cell Lung Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SABR
Arm Type
Experimental
Arm Description
SABR group includes patients receiving pre-identified fractionated Stereotactic Ablative Radiotherapy (SABR)
Intervention Type
Radiation
Intervention Name(s)
Stereotactic Ablative Radiotherapy (SABR)
Other Intervention Name(s)
Stereotactic body radiation therapy (SBRT)
Intervention Description
Six Gy irradiation per fraction times 12 fractionations, resulting a total dose of 72Gy
Primary Outcome Measure Information:
Title
Local regional progression free survival
Description
Duration between radiotherapy commencement and local progression, regional progression, death of cancer or last date of follow up.
Time Frame
2 year
Secondary Outcome Measure Information:
Title
Objective response rate
Description
Tumor response to radiotherapy evaluated by RECIST 1.1
Time Frame
1 month after RT
Title
Progression free survival
Description
Duration between radiotherapy commencement and any progression, death of cancer or last date of follow up.
Time Frame
2 year
Title
Overall survival
Description
Duration between radiotherapy commencement and any cause of death or last date of follow up.
Time Frame
2 year
Title
Grade ≥ 2 radiation induced normal tissue toxicity
Description
Incidence of radiation induced toxicities on lung, oesophagus, rib or chest wall pain assessed by CTCAE v 4.0
Time Frame
1 year
Title
Questionnaire on quality of life
Description
Physical and psychologic status assessed by specific questionnaire
Time Frame
2 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jingbo Wang, Dr.
Phone
8610-87788503
Email
wangjingbo303@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Luhua Wang, Dr.
Phone
8610-87788799
Email
wlhwq@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jingbo Wang, Dr.
Organizational Affiliation
Cancer Hospital/Institute, Chinese Academy of Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cancer Hospital/Institute, Chinese Academy of Medical Sciences
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100021
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jingbo Wang, Dr.
Phone
8610-87788503
Email
wangjingbo303@yahoo.com
First Name & Middle Initial & Last Name & Degree
Luhua Wang, Dr.
Phone
8610-87788799
Email
wlhwq@yahoo.com
First Name & Middle Initial & Last Name & Degree
Jingbo Wang, Dr.
First Name & Middle Initial & Last Name & Degree
Luhua Wang, Dr.
First Name & Middle Initial & Last Name & Degree
Zhouguang Hui, Dr.
First Name & Middle Initial & Last Name & Degree
JianYang Wang, Dr.

12. IPD Sharing Statement

Citations:
PubMed Identifier
8087777
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. doi: 10.1002/1097-0142(19941001)74:7+3.0.co;2-m.
Results Reference
background
PubMed Identifier
21108881
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.
Results Reference
background
PubMed Identifier
12784323
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. doi: 10.1002/cncr.11380. Erratum In: Cancer. 2005 Jun 15;103(12):2658.
Results Reference
background
PubMed Identifier
17505036
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. doi: 10.1378/chest.06-3096. Epub 2007 May 15.
Results Reference
background
PubMed Identifier
11462066
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. doi: 10.1136/thorax.56.8.628.
Results Reference
background
PubMed Identifier
8226142
Citation
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.
Results Reference
background
PubMed Identifier
20233825
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.
Results Reference
background
PubMed Identifier
22727222
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.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs