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Phase I/II Study of Fractionated Stereotactic Radiotherapy for Early Stage Non-Small Cell Lung Cancer

Primary Purpose

Non-small Cell Lung Cancer

Status
Completed
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
Stereotactic Radiotherapy
Sponsored by
AHS Cancer Control Alberta
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-small Cell Lung Cancer focused on measuring Fractionated stereotactic radiotherapy, Medically inoperable, Image-guided radiotherapy

Eligibility Criteria

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

Inclusion Criteria:

  • T1-T3N0 non-small cell lung cancer (maximum dimensions of 5cm, T3 by chestwall involvement only)
  • Medically inoperable due to co-morbid conditions or patient preference for radiation
  • adequate pulmonary function to withstand radical treatment (ie. FEV1 greater than 40% of predicted), as assessed by consulting radiation oncologist
  • age greater than or equal to 18, and Karnofsky performance status greater than of equal to 70

Exclusion Criteria:

  • Presence of mediastinal metastases or distant metastases
  • Life expectancy less than 1 year due to other co-morbid conditions

Sites / Locations

  • Tom Baker Cancer Center
  • Cross Cancer Institute

Outcomes

Primary Outcome Measures

Local Control

Secondary Outcome Measures

Toxicity
Quality of Life

Full Information

First Posted
April 27, 2009
Last Updated
March 14, 2016
Sponsor
AHS Cancer Control Alberta
Collaborators
Cross Cancer Institute
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1. Study Identification

Unique Protocol Identification Number
NCT00888823
Brief Title
Phase I/II Study of Fractionated Stereotactic Radiotherapy for Early Stage Non-Small Cell Lung Cancer
Official Title
Multicentre, Phase I/II Study of Fractionated Stereotactic Radiotherapy for Medically Inoperable Early Stage Non-Small Cell Lung Cancer (NSCLC)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AHS Cancer Control Alberta
Collaborators
Cross Cancer Institute

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
A new type of treatment called stereotactic radiotherapy has recently been developed in hopes of improving the success of the treatment and improving the convenience to patients, while reducing the side effects. This study is developing stereotactic radiotherapy as a state-of-the-art treatment for lung cancer patients.
Detailed Description
OBJECTIVES: Primary Objectives To determine the efficacy of hypofractionated, image guided radiotherapy in treating patients with lung tumours, with the primary outcome being local control at one year. To determine the toxicity of high dose, small field,hypofractionated radiotherapy to the lung, based on the RTOG and CTCAE scales.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer
Keywords
Fractionated stereotactic radiotherapy, Medically inoperable, Image-guided radiotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Radiation
Intervention Name(s)
Stereotactic Radiotherapy
Intervention Description
Stereotactic Radiotherapy
Primary Outcome Measure Information:
Title
Local Control
Time Frame
One Year
Secondary Outcome Measure Information:
Title
Toxicity
Time Frame
One Year
Title
Quality of Life
Time Frame
One Year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: T1-T3N0 non-small cell lung cancer (maximum dimensions of 5cm, T3 by chestwall involvement only) Medically inoperable due to co-morbid conditions or patient preference for radiation adequate pulmonary function to withstand radical treatment (ie. FEV1 greater than 40% of predicted), as assessed by consulting radiation oncologist age greater than or equal to 18, and Karnofsky performance status greater than of equal to 70 Exclusion Criteria: Presence of mediastinal metastases or distant metastases Life expectancy less than 1 year due to other co-morbid conditions
Facility Information:
Facility Name
Tom Baker Cancer Center
City
Calgary
State/Province
Alberta
Country
Canada
Facility Name
Cross Cancer Institute
City
Edmonton
State/Province
Alberta
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

Phase I/II Study of Fractionated Stereotactic Radiotherapy for Early Stage Non-Small Cell Lung Cancer

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