Optimizing the Delineation of the Tumour Bed in Breast Irradiation

Breast Cancer Clinical Trial

Official title:

Optimizing the Delineation of the Tumour Bed in Breast Irradiation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02626858
• Other study ID #: s54017
• Status: Completed
• Phase: N/A
• First received: September 28, 2015
• Last updated: December 7, 2015
• Start date: February 2012
• Est. completion date: July 2015

Study information

• Verified date: February 2012
• Source: Universitaire Ziekenhuizen Leuven
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

Start of the study: february 2012

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: July 2015
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Device:
• extra treatment planning CT-scan
Beside the standard post-operative CT-scan, an extra pre-operative CT-scan is performed.

Locations

Country	Name	City	State
Belgium	UZ Leuven	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	the volume of the delineated CTVboost (cm3) with and without the fusion of the pre-operative CT-scan.		2 years	No
Secondary	the correlation of the Cavity Visibility Scale (CVS) to volume changes and IOV		2 Years	No
Secondary	the volume changes over time (in case of adjuvant chemotherapy)		2 years	No
Secondary	the usefulness of the surgical clips assessed by the 6 observers.		2 years	No