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Recruiting NCT01185132

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

Phase III Interventional Breast Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: accelerated partial breast irradiation - 3D-conformal planning, accelerated partial breast irradiation - IMRT planning.
Who it may be relevant to
Registry conditions: Breast Cancer. Basic parameters: from 40 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

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.

Interventions

  • Radiation accelerated partial breast irradiation - 3D-conformal planning
    38.5 Gy, 10 fractions over 5 days
  • Radiation accelerated partial breast irradiation - IMRT planning
    38.5 Gy, 10 fractions over 5 days

Primary outcome measures

  • 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]
Secondary outcome measures (7)
  • Dosimetric comparison [Time frame: 5-10 days]
  • Acute skin reactions [Time frame: 6 months]
  • Cosmetic outcomes after APBI [Time frame: 2-5 years]
  • Ipsilateral breast event [Time frame: 5-15 years]
  • Cause specific survival [Time frame: 5-15 years]
  • Disease free survival [Time frame: 5-15 years]
  • Overall survival [Time frame: 5-15 years]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 5 centers
  • Rocky Mountain Cancer Centers - Aurora — Aurora
  • Rocky Mountain Cancer Centers - Boulder — Boulder
  • Rocky Mountain Cancer Centers - Lakewood — Lakewood
  • Rocky Mountain Cancer Centers - Littleton — Littleton
  • Rocky Mountain Cancer Centers - Thornton — Thornton

Publications

  • Leonard CE, Wang Y, Asmar L, Lei RY, Howell KT, Henkenberns PL, Johnson TK, Hobart TL, Tole SP, Kercher JM, Widner JL, Barke L, Kaske T, Carter DL. A prospective Phase III trial evaluating patient self-reported pain and cosmesis in accelerated partial breast irradiation utilizing 3-D versus intensity-modulated radiotherapy. Cancer Med. 2021 Oct;10(20):7089-7100. doi: 10.1002/cam4.4242. Epub 2021 S PMID 34469056

Identifiers

NCT: NCT01185132 · 2009-APBI · WIRB #20091193

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗