Pre- Versus Postoperative Accelerated Partial Breast Irradiation

NCT02913729 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2022-09-29

No results posted yet for this study

Summary

Most of the local recurrences (LR) found after breast-conserving therapy are within or close to the tumor bed. This pattern of recurrence was confirmed by studies of breast conserving surgery without adjuvant irradiation and by the update of the NSABP B-06 trial. In the EORTC boost trial, however, 29% of all LR were found outside the area of the original tumor. Still, a recent review of Breast Conserving Therapy (BCT) trials showed that the site of local recurrences after BCT was mostly in the tumor bed, with less than 10% of LR elsewhere in the breast. This led to the concept of partial breast irradiation. With accelerated partial breast irradiation (APBI), a limited volume of breast tissue is irradiated, allowing for a higher dose per fraction compared to whole breast irradiation (WBI), which is favorable considering the low alpha/beta ratio, and thus higher sensitivity to high dose per fraction.

Conditions

Interventions

RADIATION

partial breast irradiation

irradiation

Sponsors & Collaborators

  • Institut Curie

    collaborator OTHER
  • The Netherlands Cancer Institute

    lead OTHER

Principal Investigators

  • Astrid Scholten, MD, PhD · The Netherlands Cancer Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
51 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-10
Primary Completion
2022-02-28
Completion
2022-02-28

Countries

  • France
  • Netherlands
  • Portugal
  • Spain

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02913729 on ClinicalTrials.gov