Recruiting
Phase 3

IMRT vs. APBI

Sponsor:

Rocky Mountain Cancer Centers

Code:

NCT01185132

Conditions

Breast Cancer

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

Interventions

accelerated partial breast irradiation - 3D-conformal planning

accelerated partial breast irradiation - IMRT planning

Study Details

Brief summary:

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

Study ID

NCT01185132

Start date

Jul, 2009

Status verified date

Jun, 2014

Completion date

Jul, 2028

Anticipated

Primary completion date

Jul, 2018

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

Inclusion 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.

Exclusion Criteria:

  • 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.

Study Design

Enrollment

660 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: IMRT

Intensity modulated radiotherapy, 38.5 Gy, 10 fractions over 5 days

active comparator: 3D-CRT

Three dimensional conformal external radiotherapy, 38.5 Gy, 10 fractions over 5 days

Interventions

accelerated partial breast irradiation - 3D-conformal planning

38.5 Gy, 10 fractions over 5 days

accelerated partial breast irradiation - IMRT planning

38.5 Gy, 10 fractions over 5 days

Primary outcome measure

  • Prevalence of breast pain after Accelerated Partial Breast Radiotherapy (APBI) [ Time Frame: 5 years ]
  • Prevalence of chest wall pain after Accelerated Partial Breast Radiotherapy (APBI) [ Time Frame: 2-5 years ]

Central Contacts and Locations

Central contacts

Rachel Lei, BS

303-418-7607rachel.lei@usoncology.com

Charles Leonard, MD

303-730-4700

Locations

Rocky Mountain Cancer Centers - Aurora

Recruiting

Aurora, Colorado, United States, 80012

Rocky Mountain Cancer Centers - Boulder

Recruiting

Boulder, Colorado, United States, 80303

Rocky Mountain Cancer Centers - Lakewood

Recruiting

Lakewood, Colorado, United States, 80228

Principal Investigator:

Charles Leonard, MD

Rocky Mountain Cancer Centers - Littleton

Recruiting

Littleton, Colorado, United States, 80120

Principal Investigator:

Charles Leonard, MD

Rocky Mountain Cancer Centers - Thornton

Recruiting

Thornton, Colorado, United States, 80260

More Information

Sponsor

Rocky Mountain Cancer Centers

Last update posted

Jun 26, 2014

Last verified

Jun, 2014

Keywords

  • 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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Rocky Mountain Cancer Centers on 2014-06-26.