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

Tracking Information

First Received Date ^ICMJE

July 11, 2006

Last Updated Date

January 18, 2012

Start Date ^ICMJE

September 2006

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00351962 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1
Phase 2

Study Design ^ICMJE

Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Lung Neoplasms
Lung Cancer

Intervention ^ICMJE

Procedure: Fractionated Stereotactic Radiotherapy

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Completion Date

Not Provided

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Harold P Lau, MD

403-521-3012

Location Countries ^ICMJE

Canada

Administrative Information

NCT Number ^ICMJE

NCT00351962

Other Study ID Numbers ^ICMJE

20131

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Alberta Health Services

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Harold P Lau, MD

Tom Baker Cancer Center

Information Provided By

Alberta Health Services

Verification Date

January 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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