Phase I/II Study of Fractionated Stereotactic Radiotherapy for Medically Inoperable Non-Small Cell Lung Cancer (NSCLC) or Metastatic Lung Tumours

This study is currently recruiting participants.

Verified January 2012 by Alberta Health Services

First Received on July 11, 2006. Last Updated on January 18, 2012 History of Changes

Sponsor:	Alberta Health Services
Information provided by:	Alberta Health Services
ClinicalTrials.gov Identifier:	NCT00351962

Purpose

Medically inoperable lung cancer or metastatic lung tumours will be treated with fractionated stereotactic radiation using a schedule of 1) 12 Gy x 4 treatments or 2) 6 Gy x 10 treatments.

Condition	Intervention	Phase
Lung Neoplasms Lung Cancer	Procedure: Fractionated Stereotactic Radiotherapy	Phase I Phase II

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Phase I/II Study of Fractionated Stereotactic Radiotherapy for Medically Inoperable Non-Small Cell Lung Cancer (NSCLC) or Metastatic Lung Tumours

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer

U.S. FDA Resources

Further study details as provided by Alberta Health Services:

Primary Outcome Measures:

Dose-limiting toxicity as defined by CTCAE V3 grade 4 or 5.

Estimated Enrollment:	58
Study Start Date:	September 2006

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

non-small cell lung cancer less than 6cm; no mediastinal or distant metastases
Open to Alberta,Canada Residents

Exclusion Criteria:

tumour size greater than 6cm; inadequate pulmonary function(ie. FEV1 less than 0.8 L), Karnofsky performance status less than 70, multiple co-morbid conditions

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00351962

Contacts

Contact: Harold P Lau, MD

403-521-3012

Locations

Canada, Alberta
Tom Baker Cancer Center	Recruiting
Calgary, Alberta, Canada, T2N 4N2
Contact: Marilyn David 403-521-3619 marilyn.david@albertahealthservices.ca

Sponsors and Collaborators

Alberta Health Services

Investigators

Principal Investigator:

Harold P Lau, MD

Tom Baker Cancer Center

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00351962 History of Changes
Other Study ID Numbers:	20131
Study First Received:	July 11, 2006
Last Updated:	January 18, 2012
Health Authority:	Canada: Health Canada

Keywords provided by Alberta Health Services:

lung neoplasms
metastatic lung cancer
stereotactic radiation

Additional relevant MeSH terms:

Neoplasms
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms

Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on February 09, 2012