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

October 21, 2015 updated by: Luhua Wang

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

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100021
        • Recruiting
        • Cancer Hospital/Institute, Chinese Academy of Medical Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

70 years and older (OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SABR
SABR group includes patients receiving pre-identified fractionated Stereotactic Ablative Radiotherapy (SABR)
Radiation: Stereotactic Ablative Radiotherapy (SABR)
Six Gy irradiation per fraction times 12 fractionations, resulting a total dose of 72Gy
Other Names:
  • Stereotactic body radiation therapy (SBRT)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Local regional progression free survival
Time Frame: 2 year
Duration between radiotherapy commencement and local progression, regional progression, death of cancer or last date of follow up.
2 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective response rate
Time Frame: 1 month after RT
Tumor response to radiotherapy evaluated by RECIST 1.1
1 month after RT
Progression free survival
Time Frame: 2 year
Duration between radiotherapy commencement and any progression, death of cancer or last date of follow up.
2 year
Overall survival
Time Frame: 2 year
Duration between radiotherapy commencement and any cause of death or last date of follow up.
2 year
Grade ≥ 2 radiation induced normal tissue toxicity
Time Frame: 1 year
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
Time Frame: 2 year
Physical and psychologic status assessed by specific questionnaire
2 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Luhua Wang

Investigators

  • Principal Investigator: Jingbo Wang, Dr., Cancer Hospital/Institute, Chinese Academy of Medical Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2015

Primary Completion (Anticipated)

July 1, 2018

Study Completion (Anticipated)

July 1, 2018

Study Registration Dates

First Submitted

August 13, 2015

First Submitted That Met QC Criteria

October 21, 2015

First Posted (Estimate)

October 23, 2015

Study Record Updates

Last Update Posted (Estimate)

October 23, 2015

Last Update Submitted That Met QC Criteria

October 21, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 33320140105

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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