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 enrollmentMarch 2010

ConditionsNon-small Cell Lung Cancer

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Non-small Cell Lung Cancer
Sponsor: AHS Cancer Control Alberta
Enrollment: 13
Locations: 2
Primary Endpoint: Local Control
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

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.

Registry

clinicaltrials.gov

Start Date

March 2010

End Date

June 2014

Last Updated

10 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

AHS Cancer Control Alberta

Responsible Party

Sponsor

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