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 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 us to focus treatment on the tumor and exclude more normal tissues. Therefore, we hope to these methods will prove a better way in treating people with NSCLC.

Condition	Intervention	Phase
-carcinoma -non-small cell lung	Procedure: Tomotherapy	Phase I

Further Study Details: 

Primary Outcomes: -safety and adverse events
Secondary Outcomes: -efficacy and survival
Expected Total Enrollment:  30

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: the lung can move up to 4cm 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 us 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 us to create a more refined tumor volume treated and exclude more of the normal tissues. Consequently, we hope these methods will prove to be a better way to treat patients with non-resectable NSCLC.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• stage I-III NSCLC
• KPS equal to or greater than 70
• FEV1 equal to or greater than 1.0L

Exclusion Criteria:

• MI disease
• recurrent disease
• complete tumour resection

Please refer to this study by ClinicalTrials.gov identifier  NCT00129012

Wilson Roa, MD      780-432-8783    wilsonro@cancerboard.ab.ca

Canada, Alberta
      Cross Cancer Institute, Edmonton,  Alberta,  T6G 1Z2,  Canada; Recruiting

Study chairs or principal investigators

Wilson Roa, MD,  Principal Investigator,  Alberta Cancer Board   

Study ID Numbers:  LU-11-0051
Last Updated:  August 10, 2005
Record first received:  August 9, 2005
ClinicalTrials.gov Identifier:  NCT00129012
Health Authority: Canada: Health Canada
ClinicalTrials.gov processed this record on 2005-08-23