RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2009-07
Study Completion:2028-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT01185132

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.

Ages Eligible for Study:40 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Histologically confirmed disease (AJC Classification): Tis, T1, T2 (≤ 3.0 cm), N0, M0.
  2. * Microscopic multifocal disease is only allowed when the entire span of identified disease measures 3.0 cm or less.
  3. * Negative surgical margins ( ≥ 0.2 cm) after final surgery.
  4. * 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.
  5. * Subjects with DCIS will be included in the study only if they had an MRI prior to lumpectomy.
  6. * 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.
  7. * Subjects with malignant calcifications on mammography will be required to have repeat mammography after surgery to ensure removal of all malignant calcifications.
  8. * Willing to complete additional screening requirements and meet eligibility criteria as defined in protocol Sec. 4.4.
  9. * Successful placement of fiducial markers for IGRT requiring nonmigrating fiducials.
  10. * PTV to ipsilateral breast ratio (IBR) ≤ 25 %.
  11. * Radiotherapy anticipated to begin within 10 weeks of lumpectomy or re-excision of margins.
  1. * Pregnancy or breast-feeding.
  2. * Have collagen-vascular disease.
  3. * Inadequate surgical margins ( \< 0.2 cm) after final surgery.
  4. * Subjects with persistent malignant/suspicious micro-calcifications.
  5. * Gross multifocal disease and microscopic disease greater than 3.0 cm.

Contacts and Locations

Study Contact

Rachel Lei, BS
CONTACT
303-418-7607
rachel.lei@usoncology.com
Charles Leonard, MD
CONTACT
303-730-4700

Principal Investigator

Charles Leonard, MD
PRINCIPAL_INVESTIGATOR
Rocky Mountain Cancer Centers

Study Locations (Sites)

Rocky Mountain Cancer Centers - Aurora
Aurora, Colorado, 80012
United States
Rocky Mountain Cancer Centers - Boulder
Boulder, Colorado, 80303
United States
Rocky Mountain Cancer Centers - Lakewood
Lakewood, Colorado, 80228
United States
Rocky Mountain Cancer Centers - Littleton
Littleton, Colorado, 80120
United States
Rocky Mountain Cancer Centers - Thornton
Thornton, Colorado, 80260
United States

Collaborators and Investigators

Sponsor: Rocky Mountain Cancer Centers

  • Charles Leonard, MD, PRINCIPAL_INVESTIGATOR, Rocky Mountain Cancer Centers

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2009-07
Study Completion Date2028-07

Study Record Updates

Study Start Date2009-07
Study Completion Date2028-07

Terms related to this study

Keywords Provided by Researchers

  • breast-conservation
  • adjuvant radiotherapy
  • breast cancer
  • early-stage breast cancer
  • DCIS
  • lumpectomy
  • accelerated partial breast irradiation
  • APBI
  • three dimensional conformal external radiotherapy
  • intensity modulated radiotherapy
  • 3D CRT
  • IMRT

Additional Relevant MeSH Terms

  • Breast Cancer