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

/Home/Lung Cancer Healthcare and Treatment/Lung Cancer Clinical Trials/Non Small Cell Lung Cancer Clinical Trials

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 Radiation Therapy
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 [history]
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:
Neoplasms by Site
Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Histologic Type



ClinicalTrials.gov processed this record on February 10, 2009


Back to top of Main Content


U.S. National Library of Medicine, Contact Help Desk
U.S. National Institutes of Health, U.S. Department of Health & Human Services,
USA.gov, Copyright, Privacy, Accessibility, Freedom of Information Act