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Prospective Trial of Two Prone Breast Radiotherapy Techniques With Randomization to Concurrent Versus Weekly Boost

NCT01591811 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 433

Last updated 2021-01-19

No results posted yet for this study

Summary

1. To test the hypothesis that when prone, patients treated with 3D-CRT breast radiotherapy and randomly assigned to either a weekly or a daily boost to the tumor bed develop acute toxicity that is not significantly worse than that of a concurrent cohort of patients treated with IMRT randomly assigned to a weekly or daily boost regimen.
2. To test the hypothesis that when prone, patients treated with 3D-CRT breast radiotherapy, randomly assigned to either a weekly or a daily boost to the tumor bed develop late toxicity that is not significantly worse than that of concurrent cohort of patients treated with IMRT randomly assigned to a weekly of daily boost.
3. To test hypothesis that 5 year local control rates of ≤ 5% in-breast recurrence can be achieved in each of the two randomized arms, for either technique tested.

Conditions

Interventions

RADIATION

Arm 1 Daily Boost of Radiation Therapy

Arm 1 Daily boost. IMRT at 2.7Gy x15 fractions. Total dose 40.50Gy. Daily Boost 0.5Gy to tumor bed x 15 fractions. Tumor Bed Total=48Gy

RADIATION

Arm 2 Weekly Boost of Radiation Therapy

Arm2: IMRT at 2.7Gy x 15 fractions. Total Dose=40.50 Gy. Weekly Boost 2Gy (on Friday). Tumor Bed Total 46.50Gy

Sponsors & Collaborators

Principal Investigators

  • Carmen Perez, M.D., Ph.D. · NYU Langone Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-04-16
Primary Completion
2015-04-30
Completion
2015-04-30

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

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 NCT01591811 on ClinicalTrials.gov