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

Completed

• Conditions: Breast Cancer
• Interventions: Other: CBCT imaging

• Registration Number: NCT03385031
• Lead Sponsor: Maastricht Radiation Oncology

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.

Study Timeline

• Study First Submitted: 2017-12-20
• Study First Submitted QC: 2017-12-20
• Study First Posted: 2017-12-28
• Study Start: 2018-01-01
• Status Verified: 2018-08
• Primary Completion: 2018-08-20
• Study Completion: 2018-08-20
• Last Update Submitted: 2019-03-07
• Last Update Posted: 2019-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 46

Inclusion Criteria

• Breast cancer patients
• Planned for external beam radiation treatment.
• Whole breast irradiation or Simultaneous integrated boost

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
group 1	CBCT imaging	whole breast irradiation, CBCT imaging at first and last fraction of radiotherapy treatment
group 3	CBCT imaging	patients with seroma at start radiation treatment (whole breast irradiation or simultaneous integrated boost), CBCT imaging at first and last fraction of radiotherapy treatment
group 2	CBCT imaging	simultaneous integrated boost, CBCT imaging at first and last fraction of radiotherapy treatment

Primary Outcome Measures

Name	Time	Method
Validation of quantitative action levels	3-4 weeks (time between 1st and last fraction of radiotherapy)	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

Secondary Outcome Measures

Name	Time	Method
Automatic re-delineation	3-4 weeks (time between 1st and last fraction or radiotherapy)	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.

Trial Locations

Locations (1)

Maastricht Radiation Oncology; 🇳🇱 Maastricht, Netherlands