Optimizing the Delineation of the Tumour Bed in Breast Irradiation

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Device: extra treatment planning CT-scan

Detailed Description

Start of the study: february 2012

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Leuven, Belgium, 3000
    • UZ Leuven

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: extra treatment planning CT-scan; Extra pre-operative CT-scan for treatment planning in RT	Device: extra treatment planning CT-scan; Beside the standard post-operative CT-scan, an extra pre-operative CT-scan is performed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

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

Collaborators and Investigators

• Sponsor: Universitaire Ziekenhuizen KU Leuven
• Investigators: Principal Investigator: Caroline Weltens, PhD, Universitaire Ziekenhuizen KU Leuven

Study record dates

Study Major Dates

• Study Start: February 1, 2012
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): July 1, 2015

Study Registration Dates

• First Submitted: September 28, 2015
• First Submitted That Met QC Criteria: December 7, 2015
• First Posted (Estimate): December 10, 2015

Study Record Updates

• Last Update Posted (Estimate): December 10, 2015
• Last Update Submitted That Met QC Criteria: December 7, 2015
• Last Verified: February 1, 2012

More Information

Terms related to this study

• Other Study ID Numbers: s54017