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

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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00129012
Enrollment
30
Registered
2005-08-11
Start date
2005-04-30
Completion date
2006-09-30
Last updated
2016-02-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Keywords

radiation therapy, carcinoma, non-small cell lung

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.

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.

Interventions

PROCEDURETomotherapy

Sponsors

Cross Cancer Institute
CollaboratorOTHER
AHS Cancer Control Alberta
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frame
safety and adverse events

Secondary

MeasureTime frame
efficacy and survival

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026