Self-Gated Breath-Hold Technique for Helical Tomotherapy in Patients With Non-Small Cell Lung Cancer

Sponsor
AHS Cancer Control Alberta (Other)
Overall Status
Completed
CT.gov ID
NCT00129012
Collaborator
Cross Cancer Institute (Other)
30
1
17
1.8

Study Details

Study Description

Brief Summary

Non-small cell lung cancer (NSCLC) is a disease that often cannot be surgically operated on. As a result, treating the tumor with radiation has become the main standard of treatment. Radiation therapy though, is limited by various factors, including the difficulty in properly imaging the lung tumor since the lung can move up to 4 cm between breathing in and out. Consequently, a radiation oncologist must consider a larger area of the lung to treat with radiation - increasing the amount of normal tissue exposed to harmful rays and therefore leading to increased side-effects. Two techniques being explored into improving tumor management while minimizing the side effects in NSCLC are breath-held gating and tomotherapy. Breath-held gating is a technique for consistently imaging the tumor at the right moment in a patient's breathing cycle - decreasing the normal tissue exposed to harmful radiation. Tomotherapy, a new technique in delivering radiation, will further allow the investigators to focus treatment on the tumor and exclude more normal tissues. Therefore, they hope that these methods will prove to be a better way in treating people with NSCLC.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Tomotherapy
Phase 1

Detailed Description

Non-small cell lung cancer (NSCLC) is a disease that often presents as an unresectable tumor. As a result, radiotherapy is the main standard of treatment. Unfortunately, radiotherapy is limited by several factors, including that the lung can move up to 4 cm between inspiration and expiration. As a result, a radiation oncologist often has to widen his treatment field to include for this motion. This leads to greater side effects for the patient. Two techniques that are being explored to improve the tumor control of radiotherapy and to minimize side effects to normal tissues in NSCLC treatment include breath-held gating and tomotherapy. Breath-held gating will allow the investigators to treat patients at the right moment in their breathing cycle consistently - minimizing the normal tissue exposed to radiation. In addition, both gated breathing and tomotherapy will allow the investigators to create a more refined tumor volume treated and exclude more of the normal tissues. Consequently, they hope these methods will prove to be a better way to treat patients with non-resectable NSCLC.

Study Design

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Self-Gated Breath-Hold Technique for Helical Tomotherapy in Patients With Non-Small Cell Lung Cancer: A Feasibility Study
Study Start Date :
Apr 1, 2005
Actual Primary Completion Date :
Sep 1, 2006
Actual Study Completion Date :
Sep 1, 2006

Outcome Measures

Primary Outcome Measures

  1. safety and adverse events []

Secondary Outcome Measures

  1. efficacy and survival []

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Stage I-III NSCLC

  • Karnofsky Performance Status (KPS) equal to or greater than 70

  • Forced expiratory volume in 1 second (FEV1) equal to or greater than 1.0L

Exclusion Criteria:
  • Myocardial infarction (MI) disease

  • Recurrent disease

  • Complete tumour resection

Contacts and Locations

Locations

Site City State Country Postal Code
1 Cross Cancer Institute Edmonton Alberta Canada T6G 1Z2

Sponsors and Collaborators

  • AHS Cancer Control Alberta
  • Cross Cancer Institute

Investigators

  • Principal Investigator: Wilson Roa, MD, AHS Cancer Control Alberta

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
AHS Cancer Control Alberta
ClinicalTrials.gov Identifier:
NCT00129012
Other Study ID Numbers:
  • LU-11-0051 / 21808
First Posted:
Aug 11, 2005
Last Update Posted:
Feb 25, 2016
Last Verified:
Mar 1, 2012
Keywords provided by AHS Cancer Control Alberta
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 25, 2016