Intensity Modulated Radiotherapy (IMRT) vs. 3D-conformal Accelerated Partial Breast Irradiation (APBI) for Early Stage Breast Cancer After Lumpectomy
2009-APBI
A Phase III Randomized Study Comparing Intensity Modulated Planning Versus 3-Dimensional Planning for Accelerated Partial Breast Radiotherapy
2 other identifiers
interventional
660
1 country
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 breast-cancer
Started Jul 2009
Longer than P75 for phase_3 breast-cancer
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2009
CompletedFirst Submitted
Initial submission to the registry
August 18, 2010
CompletedFirst Posted
Study publicly available on registry
August 19, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2028
ExpectedJune 26, 2014
June 1, 2014
9 years
August 18, 2010
June 24, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Prevalence of breast pain after Accelerated Partial Breast Radiotherapy (APBI)
Assessment by both treating investigators and by subjective patient outcomes questionnaires filled out at each follow-up visit
5 years
Prevalence of chest wall pain after Accelerated Partial Breast Radiotherapy (APBI)
Assessment by both treating investigators and by subjective patient outcomes questionnaires filled out at each follow-up visit
2-5 years
Secondary Outcomes (7)
Dosimetric comparison
5-10 days
Acute skin reactions
6 months
Cosmetic outcomes after APBI
2-5 years
Ipsilateral breast event
5-15 years
Cause specific survival
5-15 years
- +2 more secondary outcomes
Study Arms (2)
IMRT
EXPERIMENTALIntensity modulated radiotherapy, 38.5 Gy, 10 fractions over 5 days
3D-CRT
ACTIVE COMPARATORThree dimensional conformal external radiotherapy, 38.5 Gy, 10 fractions over 5 days
Interventions
38.5 Gy, 10 fractions over 5 days
38.5 Gy, 10 fractions over 5 days
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
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
Related Publications (1)
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.
PMID: 34469056DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Charles Leonard, MD
Rocky Mountain Cancer Centers
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 18, 2010
First Posted
August 19, 2010
Study Start
July 1, 2009
Primary Completion
July 1, 2018
Study Completion (Estimated)
July 1, 2028
Last Updated
June 26, 2014
Record last verified: 2014-06