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Randomized Study on Postmenopausal Women With Early Stage Breast Cancer: WBI Versus APBI

NCT02375048 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 179

Last updated 2018-10-24

No results posted yet for this study

Summary

Selected patients with early stage breast cancer undergone conservative surgery were randomized in two arms: Hypofractionated Whole Breast Irradiation versus Accelerated Partial Breast Irradiation.

Conditions

  • Cancer of Breast

Interventions

RADIATION

Hypofractionated WBI

Dose prescription was 40.5 Gy to PTVWB and 48.0 Gy to PTVboost in 15 fractions over 3 weeks, with simultaneous integrated boost delivering 2.7 and 3.2Gy/fraction for each PTV respectively. Daily image guided radiotherapy (IGRT) were generated before each treatment session in each patient to verify the set-up.

RADIATION

Accelerated Partial Breast Irradiation

APBI was delivered at a dose of 30 Gy in five 6-Gy/day fractions over 10 days (every other day) with IGRT at each treatment.

Sponsors & Collaborators

  • Istituto Clinico Humanitas

    lead OTHER

Principal Investigators

  • Marta Scorsetti, MD · Istituto Clinico Humanitas

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
55 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-19
Primary Completion
2018-02-01
Completion
2018-02-01

Countries

  • Italy

Study Locations

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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 NCT02375048 on ClinicalTrials.gov