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APBI: 27Gy in 5 Fractions for Early Breast Cancer

NCT02681107 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 274

Last updated 2019-02-21

No results posted yet for this study

Summary

This study will test the safety of partial breast RT using 27Gy in 5 daily fractions which is expected to be equally tolerated as standard whole breast irradiation (WBI) based on radiobiologic modeling of the fibrosis response of normal tissues but be more convenient and less costly than 3-6 weeks of standard WBI. 274 women will be treated. Rates of fibrosis and cosmesis at 2 years will be compared to data already collected using standard WBI in the Canadian RAPID trial.

Conditions

Interventions

RADIATION

APBI 27Gy in 5 fractions

Patients will be treated with 3-D conformal, external beam, partial breast RT to deliver 27 Gy in 5 daily fractions using 3-5 beams on a linear accelerator. The target PTV will be the CT-visible seroma plus a 1cm margin to form the CTV (minus 5mm from skin and excluding chest wall) and a further 7mm to form the PTV. Real time review will ensure compliance with target and normal tissues dose constraints in this multi-institutional study. Any (or no) systemic therapy is permitted.

Sponsors & Collaborators

  • Alberta Cancer Foundation

    collaborator OTHER

  • AHS Cancer Control Alberta

    lead OTHER

Principal Investigators

  • Petra Grendarova, MD · Tom Baker Cancer Centre, Alberta Health Services

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-31
Primary Completion
2021-07-31
Completion
2021-07-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

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 NCT02681107 on ClinicalTrials.gov