Image Guided and Breathing Adapted Radiotherapy of Early Stage Lung Cancer

NCT ID: NCT00910546

Last Updated: 2021-02-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-02-28
• Study Completion Date: 2011-04-30

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.

Conditions

Lung Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

visicoil gold marker 0.7 x 20 mm

Intervention Type: DEVICE

CT - guided implantation into lung tumors

Interventions

visicoil gold marker 0.7 x 20 mm

CT - guided implantation into lung tumors

Intervention Type: DEVICE

Other Intervention Names

Gold Ancor

Eligibility 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)

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gitte Fredberg Persson

OTHER

Sponsor Role: lead

Responsible Party

Gitte Fredberg Persson

MD PhD

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Gitte F Persson, MD

Role: PRINCIPAL_INVESTIGATOR

Rigshospitalet, Denmark

Ditte E Nygaard, MSc

Role: STUDY_CHAIR

Rigshospitalet, Denmark

Stine S Korreman, MSc PhD

Role: STUDY_CHAIR

Rigshospitalet, Denmark

Lena Specht, MD DMSc

Role: STUDY_CHAIR

Rigshospitalet, Denmark

Locations

Department of Radiation Oncology, Rigshospitalet

Copenhagen, , Denmark

Countries

Denmark

Other Identifiers

H-B-2007-016

Identifier Type: OTHER

Identifier Source: secondary_id

HPCRT002

Identifier Type: -

Identifier Source: org_study_id