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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
Sponsor:
Information provided by:
Alberta Health Services
ClinicalTrials.gov Identifier:
NCT00351962
First received: July 11, 2006
Last updated: January 18, 2012
Last verified: January 2012
History of Changes
  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 1
Phase 2

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 May 23, 2013