Image Guided and Breathing Adapted Radiotherapy of Early Stage Lung Cancer
|ClinicalTrials.gov Identifier: NCT00910546|
Recruitment Status : Completed
First Posted : June 1, 2009
Last Update Posted : December 28, 2012
|Condition or disease||Intervention/treatment|
|Lung Cancer||Device: visicoil gold marker 0.7 x 20 mm|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Image Guided and Breathing Adapted Radiotherapy of Early Stage Lung Cancer|
|Study Start Date :||February 2009|
|Primary Completion Date :||April 2011|
|Study Completion Date :||April 2011|
Experimental: Implantation of gold marker
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
CT - guided implantation into lung tumors
Other Name: Gold Ancor
- motion of lung tumours [ Time Frame: 3 weeks ]
- toxicity of implanting gold coils into lung tumours [ Time Frame: 1 year ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00910546
|Department of Radiation Oncology, Rigshospitalet|
|Copenhagen, Denmark, 2100|
|Principal Investigator:||Gitte F Persson, MD||Rigshospitalet, Denmark|
|Study Chair:||Ditte E Nygaard, MSc||Rigshospitalet, Denmark|
|Study Chair:||Stine S Korreman, MSc PhD||Rigshospitalet, Denmark|
|Study Chair:||Lena Specht, MD DMSc||Rigshospitalet, Denmark|