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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by AHS Cancer Control Alberta.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
AHS Cancer Control Alberta
ClinicalTrials.gov Identifier:
NCT00351962
First received: July 11, 2006
Last updated: January 18, 2012
Last verified: January 2012
  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:


Further study details as provided by AHS Cancer Control Alberta:

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
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, see Learn About Clinical Studies.

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
AHS Cancer Control Alberta
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 AHS Cancer Control Alberta:
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 August 21, 2014