Know Cancer

or
forgot password

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


Phase 3
40 Years
N/A
Open (Enrolling)
Both
Breast Cancer

Thank you

Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Prevalence of breast pain after Accelerated Partial Breast Radiotherapy (APBI)

Outcome Description:

Assessment by both treating investigators and by subjective patient outcomes questionnaires filled out at each follow-up visit

Outcome Time Frame:

5 years

Safety Issue:

Yes

Principal Investigator

Charles Leonard, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Rocky Mountain Cancer Centers

Authority:

United States: Institutional Review Board

Study ID:

2009-APBI

NCT ID:

NCT01185132

Start Date:

July 2009

Completion Date:

July 2028

Related Keywords:

  • Breast Cancer
  • 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
  • Breast Neoplasms

Name

Location

Rocky Mountain Cancer Centers - ThorntonThornton, Colorado  80229
Rocky Mountain Cancer Centers - AuroraAurora, Colorado  80012
Rocky Mountain Cancer Centers - LittletonLittleton, Colorado  80120
Rocky Mountain Cancer Centers - BoulderBoulder, Colorado  80303