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Completed

NCT Number: NCT00910546

Image Guided and Breathing Adapted Radiotherapy of Early Stage Lung Cancer

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.

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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Radiation Oncology, Rigshospitalet

Copenhagen, 2100, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

visicoil gold marker 0.7 x 20 mm

Device

CT - guided implantation into lung tumors

Other names: Gold Ancor

Primary outcomes

  1. motion of lung tumours

    Time frame: 3 weeks

    measured on 4DCT

Secondary outcomes

  1. toxicity of implanting gold coils into lung tumours

    Time frame: 1 year

    complication rate

Sponsors and collaborators

Lead sponsor

Gitte Fredberg Persson

Other

Registry information

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Jun 1, 2009
Registry last updated
Feb 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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