Prospective Validation of 3D Dose Metrics as Selection Criteria for Adaptive Radiotherapy in Breast Cancer Patients
1 other identifier
observational
46
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jan 2018
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 20, 2017
CompletedFirst Posted
Study publicly available on registry
December 28, 2017
CompletedStudy Start
First participant enrolled
January 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 20, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
August 20, 2018
CompletedMarch 8, 2019
August 1, 2018
8 months
December 20, 2017
March 7, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Automatic re-delineation
3-4 weeks (time between 1st and last fraction or radiotherapy)
Study Arms (3)
group 1
whole breast irradiation, CBCT imaging at first and last fraction of radiotherapy treatment
group 2
simultaneous integrated boost, CBCT imaging at first and last fraction of radiotherapy treatment
group 3
patients with seroma at start radiation treatment (whole breast irradiation or simultaneous integrated boost), CBCT imaging at first and last fraction of radiotherapy treatment
Interventions
CBCT imaging at first and last fraction of radiotherapy treatment
Eligibility Criteria
1. Whole breast irradiation (N=10) 2. Simultaneous integrated boost (N=10) 3. Patients with seroma at start radiation treatment (N=10)
You may qualify if:
- Breast cancer patients
- Planned for external beam radiation treatment.
- Whole breast irradiation or Simultaneous integrated boost
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Maastricht Radiation Oncology
Maastricht, 6202 AZ, Netherlands
Related 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.
PMID: 28849731BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Karolien Verhoeven, PHD
Radiation Oncologist
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 20, 2017
First Posted
December 28, 2017
Study Start
January 1, 2018
Primary Completion
August 20, 2018
Study Completion
August 20, 2018
Last Updated
March 8, 2019
Record last verified: 2018-08