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

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT00888823

First Posted: April 28, 2009

Last Update Posted: March 16, 2016

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Collaborator:

Cross Cancer Institute

Information provided by (Responsible Party):

AHS Cancer Control Alberta

Purpose

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.

Condition	Intervention	Phase
Non-small Cell Lung Cancer	Radiation: Stereotactic Radiotherapy	Phase 1 Phase 2


Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment
Official Title:	Multicentre, Phase I/II Study of Fractionated Stereotactic Radiotherapy for Medically Inoperable Early Stage Non-Small Cell Lung Cancer (NSCLC)

Resource links provided by NLM:

Genetics Home Reference related topics: lung cancer

MedlinePlus related topics: Lung Cancer

U.S. FDA Resources

Further study details as provided by AHS Cancer Control Alberta:

Primary Outcome Measures:

Local Control [ Time Frame: One Year ]

Secondary Outcome Measures:

Toxicity [ Time Frame: One Year ]
Quality of Life [ Time Frame: One Year ]


Enrollment:	13
Study Start Date:	March 2010
Study Completion Date:	June 2014
Primary Completion Date:	February 2014 (Final data collection date for primary outcome measure)

Intervention Details:

Stereotactic Radiotherapy

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.

Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00888823

Locations


Canada, Alberta
Tom Baker Cancer Center
Calgary, Alberta, Canada
Cross Cancer Institute
Edmonton, Alberta, Canada

Sponsors and Collaborators

AHS Cancer Control Alberta

Cross Cancer Institute

More Information


Responsible Party:	AHS Cancer Control Alberta
ClinicalTrials.gov Identifier:	NCT00888823 History of Changes
Other Study ID Numbers:	24541/ethics24761
First Submitted:	April 27, 2009
First Posted:	April 28, 2009
Last Update Posted:	March 16, 2016
Last Verified:	March 2016

Keywords provided by AHS Cancer Control Alberta:


Fractionated stereotactic radiotherapy Medically inoperable Image-guided radiotherapy

Additional relevant MeSH terms:


Lung Neoplasms Carcinoma, Non-Small-Cell Lung Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site	Neoplasms Lung Diseases Respiratory Tract Diseases Carcinoma, Bronchogenic Bronchial Neoplasms

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