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Image Guided and Breathing Adapted Radiotherapy of Early Stage Lung Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gitte Fredberg Persson, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT00910546
First received: May 28, 2009
Last updated: December 27, 2012
Last verified: December 2012
History of Changes
  Purpose

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.


Condition Intervention
Lung Cancer
 Device: visicoil gold marker 0.7 x 20 mm

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Image Guided and Breathing Adapted Radiotherapy of Early Stage Lung Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer
U.S. FDA Resources

Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:
  • motion of lung tumours [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • toxicity of implanting gold coils into lung tumours [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Enrollment: 15
Study Start Date: February 2009
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00910546

Locations
Denmark
Department of Radiation Oncology, Rigshospitalet
Copenhagen, Denmark, 2100
Sponsors and Collaborators
Gitte Fredberg Persson
Investigators
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
  More Information

No publications provided

Responsible Party: Gitte Fredberg Persson, MD PhD, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT00910546     History of Changes
Other Study ID Numbers: HPCRT002, H-B-2007-016
Study First Received: May 28, 2009
Last Updated: December 27, 2012
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics
Denmark: Danish Dataprotection Agency

Keywords provided by Rigshospitalet, Denmark:
Lung Cancer
Stereotactic radiotherapy
Image guidance
 breathing adaption
tumor motion
implanted marker

Additional relevant MeSH terms:
Respiratory Aspiration
Lung Neoplasms
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
 Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases

ClinicalTrials.gov processed this record on May 16, 2013