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

NCT ID: NCT03385031

Last Updated: 2019-03-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

46 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-01

Study Completion Date

2018-08-20

Brief Summary

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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

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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.

Conditions

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Breast Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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group 1

whole breast irradiation, CBCT imaging at first and last fraction of radiotherapy treatment

CBCT imaging

Intervention Type OTHER

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

CBCT imaging

Intervention Type OTHER

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

CBCT imaging

Intervention Type OTHER

CBCT imaging at first and last fraction of radiotherapy treatment

Interventions

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CBCT imaging

CBCT imaging at first and last fraction of radiotherapy treatment

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Breast cancer patients
* Planned for external beam radiation treatment.
* Whole breast irradiation or Simultaneous integrated boost
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Maastricht Radiation Oncology

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Karolien Verhoeven, PHD

Role: PRINCIPAL_INVESTIGATOR

Radiation Oncologist

Locations

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Maastricht Radiation Oncology

Maastricht, , Netherlands

Site Status

Countries

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Netherlands

References

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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.

Reference Type BACKGROUND
PMID: 28849731 (View on PubMed)

Related Links

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https://www.ncbi.nlm.nih.gov/pubmed/?term=(Zegers+et+al.+Acta+Oncol+2017)

Three-dimensional dose evaluation in breast cancer patients to define decision criteria for adaptive radiotherapy.

Other Identifiers

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P0268

Identifier Type: -

Identifier Source: org_study_id

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