Prospective Validation of 3D Dose Metrics as Selection Criteria for Adaptive Radiotherapy in Breast Cancer Patients

Study Overview
=================
Brief Summary
-----------------
In a retrospective study the investigators defined quantitative action levels based on dose and volume measures for adaptive radiation therapy in breast cancer patients (Zegers et al. Acta Oncol 2017). The aim of this study is to validate these parameters in a prospective study.

Detailed Description
-----------------
During radiotherapy, changes in patient anatomy or positioning can result into differences in dose deposition, which is the main factor influencing tumor control or side-effects. Dose-guided radiation therapy is the systematic evaluation of the dose delivery during treatment for an individual patient with the aim to adapt the treatment if needed. Recalculation of the dose during treatment can be performed using the imaging information during treatment. In a retrospective study the investigators defined quantitative action levels based on dose and volume measures for adaptive radiation therapy in breast cancer patients (Zegers et al. Acta Oncol 2017). The aim of this study is to validate these parameters in a prospective study.

Official Title
-----------------
Prospective Validation of 3D Dose Metrics as Selection Criteria for Adaptive Radiotherapy in Breast Cancer Patients

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Other: CBCT imaging


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Breast cancer patients Planned for external beam radiation treatment. Whole breast irradiation or Simultaneous integrated boost

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| group 1<br>whole breast irradiation, CBCT imaging at first and last fraction of radiotherapy treatment | Other: CBCT imaging<br>* CBCT imaging at first and last fraction of radiotherapy treatment<br>|
| group 2<br>simultaneous integrated boost, CBCT imaging at first and last fraction of radiotherapy treatment | Other: CBCT imaging<br>* CBCT imaging at first and last fraction of radiotherapy treatment<br>|
| group 3<br>patients with seroma at start radiation treatment (whole breast irradiation or simultaneous integrated boost), CBCT imaging at first and last fraction of radiotherapy treatment | Other: CBCT imaging<br>* CBCT imaging at first and last fraction of radiotherapy treatment<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Validation of quantitative action levels | Evaluation of DVH parameters on the CBCT of the 1st and last fraction of radiotherapy treatment. Evaluate if the changes during treatment are within the thresholds set by the previous retrospective study; are parameters within predefined criteria yes/no | 3-4 weeks (time between 1st and last fraction of radiotherapy) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Automatic re-delineation | Evaluation of automatic re-delineation of the target volume against manual re-delineation by a radiotherapy oncologist on the CBCT of the 1st and last fraction of radiotherapy treatment. | 3-4 weeks (time between 1st and last fraction or radiotherapy) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CBCT, Dose-guided radiation therapy