Skip to main content
OpenTrials
Completed

NCT Number: NCT03385031

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Maastricht Radiation Oncology

Maastricht, 6202 AZ, Netherlands

About this study

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.

Who can participate

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

Inclusion criteria

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

Treatment and study plan

CBCT imaging

Other

CBCT imaging at first and last fraction of radiotherapy treatment

Primary outcomes

  1. Validation of quantitative action levels

    Time frame: 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 outcomes

  1. Automatic re-delineation

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Maastricht Radiation Oncology

Other

Registry information

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Dec 28, 2017
Registry last updated
Mar 8, 2019

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.