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 by Alberta Cancer Board, August 2008

Sponsored by:	Alberta Cancer Board
Information provided by:	Alberta Cancer Board
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

MedlinePlus related topics: Cancer Lung Cancer

U.S. FDA Resources

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

Further study details as provided by Alberta Cancer Board:

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

Criteria

Inclusion Criteria:

non-small cell lung cancer less than 6cm; no mediastinal or distant metastases; metastatic lung tumours (two or less)

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

403-521-3842

Locations

Canada, Alberta
Tom Baker Cancer Center	Recruiting
Calgary, Alberta, Canada, T2N 4N2
Contact: Rachel Syme, PhD 403-521-3388 rachelsy@cancerboard.ab.ca

Sponsors and Collaborators

Alberta Cancer Board

Investigators

Principal Investigator:

Harold P Lau, MD

Tom Baker Cancer Center

More Information

Study ID Numbers:	20131
Study First Received:	July 11, 2006
Last Updated:	August 13, 2008
ClinicalTrials.gov Identifier:	NCT00351962
Health Authority:	Canada: Health Canada

Keywords provided by Alberta Cancer Board:

lung neoplasms
metastatic lung cancer
stereotactic radiation

Study placed in the following topic categories:

Thoracic Neoplasms
Non-small cell lung cancer
Respiratory Tract Diseases
Lung Neoplasms

Lung Diseases
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on January 14, 2009