Clinical trial NCT01185132: Intensity Modulated Radiotherapy (IMRT) vs. 3D-conformal Accelerated Partial Breast Irradiation (APBI) for Early Stage Breast Cancer After Lumpectomy
Official title: A Phase III Randomized Study Comparing Intensity Modulated Planning Versus 3-Dimensional Planning for Accelerated Partial Breast Radiotherapy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Breast Cancer
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
Lead sponsor: Rocky Mountain Cancer Centers
Sponsor class: OTHER
First posted: 2010-08-19
Enrollment: 660
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Prevalence of breast pain after Accelerated Partial Breast Radiotherapy (APBI)
timeFrame: 5 years
measure: Prevalence of chest wall pain after Accelerated Partial Breast Radiotherapy (APBI)
timeFrame: 2-5 years
Secondary outcomes:
measure: Dosimetric comparison
timeFrame: 5-10 days
measure: Acute skin reactions
timeFrame: 6 months
measure: Cosmetic outcomes after APBI
timeFrame: 2-5 years
measure: Ipsilateral breast event
timeFrame: 5-15 years
measure: Cause specific survival
timeFrame: 5-15 years
measure: Disease free survival
timeFrame: 5-15 years
measure: Overall survival
timeFrame: 5-15 years
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Rocky Mountain Cancer Centers - Aurora
state: Colorado
city: Boulder
country: United States
facility: Rocky Mountain Cancer Centers - Boulder
state: Colorado
city: Lakewood
country: United States
facility: Rocky Mountain Cancer Centers - Lakewood
state: Colorado
city: Littleton
country: United States
facility: Rocky Mountain Cancer Centers - Littleton
state: Colorado
city: Thornton
country: United States
facility: Rocky Mountain Cancer Centers - Thornton
state: Colorado
Study officials:
affiliation: Rocky Mountain Cancer Centers
name: Charles Leonard, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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 Sep 1.