Clinical trial NCT00910546: Image Guided and Breathing Adapted Radiotherapy of Early Stage Lung Cancer
Official title: Image Guided and Breathing Adapted Radiotherapy of Early Stage Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Cancer
Keywords: Lung Cancer
Stereotactic radiotherapy
Image guidance
breathing adaption
tumor motion
implanted marker
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2009-06-01
Enrollment: 15
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.

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)

Primary outcomes:
measure: motion of lung tumours
timeFrame: 3 weeks
Secondary outcomes:
measure: toxicity of implanting gold coils into lung tumours
timeFrame: 1 year
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Department of Radiation Oncology, Rigshospitalet
Study officials:
affiliation: Rigshospitalet, Denmark
name: Gitte F Persson, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rigshospitalet, Denmark
name: Ditte E Nygaard, MSc
role: STUDY_CHAIR
affiliation: Rigshospitalet, Denmark
name: Stine S Korreman, MSc PhD
role: STUDY_CHAIR
affiliation: Rigshospitalet, Denmark
name: Lena Specht, MD DMSc
role: STUDY_CHAIR
References: