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Clinical Trials/NCT00888823
NCT00888823CompletedPhase 1

Multicentre, Phase I/II Study of Fractionated Stereotactic Radiotherapy for Medically Inoperable Early Stage Non-Small Cell Lung Cancer (NSCLC)

AHS Cancer Control Alberta2 sites in 1 country13 target enrollmentStarted: March 2010Last updated:
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Conditions

Trial Snapshot

Phase
Phase 1
Status
Completed
Enrollment
13
Locations
2
Primary Endpoint
Local Control
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Local Control

Time Frame: One Year

Secondary Outcomes

  • Toxicity(One Year)
  • Quality of Life(One Year)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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