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NCT03385031 Clinical Trial

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

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03385031
Other study ID # P0268
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2018
Est. completion date August 20, 2018

Study information
Verified date August 2018
Source Maastricht Radiation Oncology
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 46
Est. completion date August 20, 2018
Est. primary completion date August 20, 2018
Accepts healthy volunteers
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Breast cancer patients

- Planned for external beam radiation treatment.

- Whole breast irradiation or Simultaneous integrated boost

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• CBCT imaging
CBCT imaging at first and last fraction of radiotherapy treatment

Locations
Country Name City State
Netherlands Maastricht Radiation Oncology Maastricht

Sponsors (1)
Lead Sponsor Collaborator
Maastricht Radiation Oncology

Country where clinical trial is conducted

Netherlands, 

References & Publications (1)

Zegers CML, Baeza JA, van Elmpt W, Murrer LHP, Verhoeven K, Boersma L, Verhaegen F, Nijsten SMJJG. Three-dimensional dose evaluation in breast cancer patients to define decision criteria for adaptive radiotherapy. Acta Oncol. 2017 Nov;56(11):1487-1494. doi: 10.1080/0284186X.2017.1349334. Epub 2017 Aug 29. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary 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 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)
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