Image Guided and Breathing Adapted Radiotherapy of Early Stage Lung Cancer

Not Applicable

Completed

• Conditions: Lung Cancer
• Interventions: Device: visicoil gold marker 0.7 x 20 mm

• Registration Number: NCT00910546
• Lead Sponsor: Gitte Fredberg Persson

Brief Summary

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

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 Timeline

• Study Start: 2009-02
• Study First Submitted: 2009-05-28
• Study First Submitted QC: 2009-05-28
• Study First Posted: 2009-06-01
• Primary Completion: 2011-04
• Study Completion: 2011-04
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-23
• Last Update Posted: 2021-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Implantation of gold marker	visicoil gold marker 0.7 x 20 mm	CT guided implantation of gold marker into early stage lung tumors. Extra 4DCT scans and fluoroscopies during planning and the 3 fraction radiotherapy course.

Primary Outcome Measures

Name	Time	Method
motion of lung tumours	3 weeks	measured on 4DCT

Secondary Outcome Measures

Name	Time	Method
toxicity of implanting gold coils into lung tumours	1 year	complication rate

Trial Locations

Locations (1)

Department of Radiation Oncology, Rigshospitalet; 🇩🇰 Copenhagen, Denmark