Intensity Modulated Radiotherapy (IMRT) vs. 3D-conformal Accelerated Partial Breast Irradiation (APBI) for Early Stage Breast Cancer After Lumpectomy

Description

In the setting of radiotherapy as part of breast-conservation therapy for patients with early stage breast cancer, the novel planning and delivery method of intensity modulated radiotherapy is an effective and safe alternative to the commonly-used standard 3D-conformal external beam radiotherapy, spares more normal breast and lung tissue, and may lead to improved clinical outcomes.

Conditions

Breast Cancer

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Study Overview

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Study Details

Study overview

In the setting of radiotherapy as part of breast-conservation therapy for patients with early stage breast cancer, the novel planning and delivery method of intensity modulated radiotherapy is an effective and safe alternative to the commonly-used standard 3D-conformal external beam radiotherapy, spares more normal breast and lung tissue, and may lead to improved clinical outcomes.

A Phase III Randomized Study Comparing Intensity Modulated Planning Versus 3-Dimensional Planning for Accelerated Partial Breast Radiotherapy

Intensity Modulated Radiotherapy (IMRT) vs. 3D-conformal Accelerated Partial Breast Irradiation (APBI) for Early Stage Breast Cancer After Lumpectomy

Condition
Breast Cancer
Intervention / Treatment

-

Contacts and Locations

Aurora

Rocky Mountain Cancer Centers - Aurora, Aurora, Colorado, United States, 80012

Boulder

Rocky Mountain Cancer Centers - Boulder, Boulder, Colorado, United States, 80303

Lakewood

Rocky Mountain Cancer Centers - Lakewood, Lakewood, Colorado, United States, 80228

Littleton

Rocky Mountain Cancer Centers - Littleton, Littleton, Colorado, United States, 80120

Thornton

Rocky Mountain Cancer Centers - Thornton, Thornton, Colorado, United States, 80260

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Histologically confirmed disease (AJC Classification): Tis, T1, T2 (≤ 3.0 cm), N0, M0.
  • * Microscopic multifocal disease is only allowed when the entire span of identified disease measures 3.0 cm or less.
  • * Negative surgical margins ( ≥ 0.2 cm) after final surgery.
  • * Subjects with infiltrating lobular histologies or high nuclear grade DCIS will be required to have breast MRI scanning as part of the initial staging to verify localized disease.
  • * Subjects with DCIS will be included in the study only if they had an MRI prior to lumpectomy.
  • * Findings on MRI scanning revealing relevant suspicion of disease outside of planned lumpectomy volume should be further evaluated by ultrasound and, if necessary biopsy, to exclude multicentric/multifocal disease.
  • * Subjects with malignant calcifications on mammography will be required to have repeat mammography after surgery to ensure removal of all malignant calcifications.
  • * Willing to complete additional screening requirements and meet eligibility criteria as defined in protocol Sec. 4.4.
  • * Successful placement of fiducial markers for IGRT requiring nonmigrating fiducials.
  • * PTV to ipsilateral breast ratio (IBR) ≤ 25 %.
  • * Radiotherapy anticipated to begin within 10 weeks of lumpectomy or re-excision of margins.
  • * Pregnancy or breast-feeding.
  • * Have collagen-vascular disease.
  • * Inadequate surgical margins ( \< 0.2 cm) after final surgery.
  • * Subjects with persistent malignant/suspicious micro-calcifications.
  • * Gross multifocal disease and microscopic disease greater than 3.0 cm.

Ages Eligible for Study

40 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Rocky Mountain Cancer Centers,

Charles Leonard, MD, PRINCIPAL_INVESTIGATOR, Rocky Mountain Cancer Centers

Study Record Dates

2028-07