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Image Guided Radiotherapy (IGRT) for Prone Partial Breast Irradiation

NCT02272400 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 310

Last updated 2021-01-14

No results posted yet for this study

Summary

Partial breast irradiation (PBI) is becoming a new paradigm for breast cancer radiation.\[1\] No type I or II evidence is currently available to demonstrate equivalence to standard whole breast radiotherapy, and a prospective randomized trial jointly sponsored by NSABP and RTOG (NSABP B-39 and RTOG 0413) is currently accruing patients, comparing whole breast radiotherapy to PBI, either by brachytherapy or external beam techniques (EB). Until the results of this or similar trials are available, PBI remains a research domain, and it should be offered to patients only in the context of a clinical experimental protocol.

Conditions

Interventions

OTHER

IGRT for prone partial breast irradiation (PBI)

IGRT for prone partial breast irradiation (PBI): All patients will be treated prone with 6 Gy/fraction delivered in 5 fractions over a 1-week period for a total dose of 30 Gy. Simulation and treatment will be started within 50 days from surgery in order to maximize the chances of optimal lumpectomy cavity visualization on the planning and cone beam CT scans. All patients will be followed monthly for the first 90 days then q3 months for the first year, then yearly for the next 10 years.

Sponsors & Collaborators

Principal Investigators

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

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-08-07
Primary Completion
2014-10-29
Completion
2014-10-29

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 NCT02272400 on ClinicalTrials.gov