Image Guided and Breathing Adapted Radiotherapy of Early Stage Lung Cancer

Study Overview
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Brief Summary
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The purpose of this study is to quantify the variation in tumour middle position during a course of stereotactic body radiotherapy (SBRT), and thereby be able to design radiotherapy margins that takes into account the full motion span throughout an entire course of SBRT.

Detailed Description
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Lung tumours move with respiration. This must be considered when designing margins for radiotherapy. This movement can be quantified by fluoroscopy or 4DCT. It is possible to identify a tumour middle position for planning. This middle position will vary from day to day and the extent of this variation is not fully known. The aim of this study is to quantify the variation in tumour middle position during a course of stereotactic body radiotherapy (SBRT), and thereby be able to design margins for patients that take into account the full motion span throughout an entire course of SBRT Patients: 15 consecutive patients with inoperable low stage lung cancer or solitary metastases to the lung (1-2) referred for SBRT - 45 Gy/3 fractions. Methods: A gold coil will be implanted into the lung tumour one week before the planning. At planning and all treatment days supplementary 4DCT of thorax and two orthogonal fluoroscopy sessions will be performed. Tumour motion in the superior-inferior, medio-lateral and cranio-caudal direction will be measured and variation in amplitude and baseline for the tumour motion will be reported. Perspective: By examining the variation in tumour movement it will be possible design margins for SBRT, accounting for the full tumour motion span and minimizing the risk of geographical miss and thereby optimizing the chance for local tumour control.

Official Title
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Image Guided and Breathing Adapted Radiotherapy of Early Stage Lung Cancer

Conditions
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Lung Cancer

Intervention / Treatment
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* Device: visicoil gold marker 0.7 x 20 mm


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: tumor > 6 cm no more than 2 tumours histological proven non small celled lung cancer signed Informed Consent Exclusion Criteria: Serious bleeding disorder Performance status 3-4 Tumour close to large vessels (judged by interventional radiologist)

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Implantation of gold marker<br>CT guided implantation of gold marker into early stage lung tumors. Extra 4DCT scans and fluoroscopies during planning and the 3 fraction radiotherapy course. | Device: visicoil gold marker 0.7 x 20 mm<br>* CT - guided implantation into lung tumors<br>* Other names: Gold Ancor;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| motion of lung tumours | measured on 4DCT | 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| toxicity of implanting gold coils into lung tumours | complication rate | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lung Cancer, Stereotactic radiotherapy, Image guidance, breathing adaption, tumor motion, implanted marker