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Completed

NCT Number: NCT02626858

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

UZ Leuven

Leuven, 3000, Belgium

About this study

Start of the study: february 2012

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

extra treatment planning CT-scan

Device

Beside the standard post-operative CT-scan, an extra pre-operative CT-scan is performed.

Primary outcomes

  1. the interobserver variability (IOV) (%) of the delineated Clinical Target Volume (CTV) boost (cm3) with and without the fusion of the pre-operative CT-scan.

    Time frame: 2 years

  2. the volume of the delineated CTVboost (cm3) with and without the fusion of the pre-operative CT-scan.

    Time frame: 2 years

Secondary outcomes

  1. the correlation of the Cavity Visibility Scale (CVS) to volume changes and IOV

    Time frame: 2 Years

  2. the volume changes over time (in case of adjuvant chemotherapy)

    Time frame: 2 years

  3. the usefulness of the surgical clips assessed by the 6 observers.

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2015
First posted
Dec 10, 2015
Registry last updated
Dec 10, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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