Optimizing the Delineation of the Tumour Bed in Breast Irradiation

Not Applicable

Completed

• Conditions: Breast Cancer
• Interventions: Device: extra treatment planning CT-scan

• Registration Number: NCT02626858
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

Brief Summary

The aim of the present study is:

1. to verify whether the delineation of the tumour bed, based on the combination of the visible postoperative changes and the position of the surgical clips on a CT scan in treatment position acquired 1 week before the start of the radiotherapy (RT), provides an accurate localisation of the boost volume compared to the localisation of the tumour on a pre-operative CT-scan.

2. to document the changes that occur in the tumour bed as seen on a CT scan as a function of the delay between surgery and radiotherapy.

3. to determine the ideal number and the positioning of the clips needed to reproduce the best treatment volume for the boost.

4. to propose new guidelines for tumour bed definition and delineation based on the study findings.

Detailed Description

Start of the study: february 2012

Study Timeline

• Status Verified: 2012-02
• Study Start: 2012-02
• Primary Completion: 2013-12
• Study Completion: 2015-07
• Study First Submitted: 2015-09-28
• Study First Submitted QC: 2015-12-07
• Last Update Submitted: 2015-12-07
• Study First Posted: 2015-12-10
• Last Update Posted: 2015-12-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 25

Inclusion Criteria

• Breast Cancer patients, without metastases, who will undergo breast conserving surgery and probably will receive adjuvant chemotherapy and thereafter radiotherapy.

Exclusion Criteria

• Metastases at time of diagnosis

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
extra treatment planning CT-scan	extra treatment planning CT-scan	Extra pre-operative CT-scan for treatment planning in RT

Primary Outcome Measures

Name	Time	Method
the interobserver variability (IOV) (%) of the delineated Clinical Target Volume (CTV) boost (cm3) with and without the fusion of the pre-operative CT-scan.	2 years
the volume of the delineated CTVboost (cm3) with and without the fusion of the pre-operative CT-scan.	2 years

Secondary Outcome Measures

Name	Time	Method
the volume changes over time (in case of adjuvant chemotherapy)	2 years
the correlation of the Cavity Visibility Scale (CVS) to volume changes and IOV	2 Years
the usefulness of the surgical clips assessed by the 6 observers.	2 years

Trial Locations

Locations (1)

UZ Leuven; 🇧🇪 Leuven, Belgium