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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2014-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Non-small Cell Lung Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Stereotactic Radiotherapy

Intervention Type RADIATION

Eligibility Criteria

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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