Back to resultsIntensity Modulated Radiotherapy (IMRT) vs. 3D-conformal Accelerated Partial Breast Irradiation (APBI) for Early Stage Breast Cancer After Lumpectomy (2009-APBI)
Primary Purpose
Breast Cancer
Status
Recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
accelerated partial breast irradiation - 3D-conformal planning
accelerated partial breast irradiation - IMRT planning
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring 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
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.
Sites / Locations
- Rocky Mountain Cancer Centers - AuroraRecruiting
- Rocky Mountain Cancer Centers - BoulderRecruiting
- Rocky Mountain Cancer Centers - LakewoodRecruiting
- Rocky Mountain Cancer Centers - LittletonRecruiting
- Rocky Mountain Cancer Centers - ThorntonRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
IMRT
3D-CRT
Arm Description
Intensity modulated radiotherapy, 38.5 Gy, 10 fractions over 5 days
Three dimensional conformal external radiotherapy, 38.5 Gy, 10 fractions over 5 days
Outcomes
Primary Outcome Measures
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
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
Secondary Outcome Measures
Dosimetric comparison
Comparison of treatment plans and actual doses received between comparable patients treated with 3D-CRT and IMRT with regard to treatment target and normal tissue
Acute skin reactions
Radiation-induced dermatitis
Cosmetic outcomes after APBI
Assesed by both treating investigators and subjective patient questionnaires filled out at each follow-up visit
Ipsilateral breast event
Track occurrence and patterns of local treatment failures or new primaries within the treated breast (efficacy outcome measure)
Cause specific survival
Track survival status and the specific cause(s) of death if applicable for study participants (efficacy outcome measure)
Disease free survival
Track breast-cancer free survival status of study participants (efficacy outcome measure)
Overall survival
Track the overall survival status of all study participants (efficacy outcome measure)
Full Information
NCT ID
NCT01185132
First Posted
August 18, 2010
Last Updated
June 24, 2014
Sponsor
Rocky Mountain Cancer Centers
1. Study Identification
Unique Protocol Identification Number
NCT01185132
Brief Title
Intensity Modulated Radiotherapy (IMRT) vs. 3D-conformal Accelerated Partial Breast Irradiation (APBI) for Early Stage Breast Cancer After Lumpectomy
Acronym
2009-APBI
Official Title
A Phase III Randomized Study Comparing Intensity Modulated Planning Versus 3-Dimensional Planning for Accelerated Partial Breast Radiotherapy
Study Type
Interventional
2. Study Status
Record Verification Date
June 2014
Overall Recruitment Status
Recruiting
Study Start Date
July 2009 (undefined)
Primary Completion Date
July 2018 (Anticipated)
Study Completion Date
July 2028 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rocky Mountain Cancer Centers
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
660 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
IMRT
Arm Type
Experimental
Arm Description
Intensity modulated radiotherapy, 38.5 Gy, 10 fractions over 5 days
Arm Title
3D-CRT
Arm Type
Active Comparator
Arm Description
Three dimensional conformal external radiotherapy, 38.5 Gy, 10 fractions over 5 days
Intervention Type
Radiation
Intervention Name(s)
accelerated partial breast irradiation - 3D-conformal planning
Other Intervention Name(s)
APBI, EBRT
Intervention Description
38.5 Gy, 10 fractions over 5 days
Intervention Type
Radiation
Intervention Name(s)
accelerated partial breast irradiation - IMRT planning
Other Intervention Name(s)
APBI, EBRT
Intervention Description
38.5 Gy, 10 fractions over 5 days
Primary Outcome Measure Information:
Title
Prevalence of breast pain after Accelerated Partial Breast Radiotherapy (APBI)
Description
Assessment by both treating investigators and by subjective patient outcomes questionnaires filled out at each follow-up visit
Time Frame
5 years
Title
Prevalence of chest wall pain after Accelerated Partial Breast Radiotherapy (APBI)
Description
Assessment by both treating investigators and by subjective patient outcomes questionnaires filled out at each follow-up visit
Time Frame
2-5 years
Secondary Outcome Measure Information:
Title
Dosimetric comparison
Description
Comparison of treatment plans and actual doses received between comparable patients treated with 3D-CRT and IMRT with regard to treatment target and normal tissue
Time Frame
5-10 days
Title
Acute skin reactions
Description
Radiation-induced dermatitis
Time Frame
6 months
Title
Cosmetic outcomes after APBI
Description
Assesed by both treating investigators and subjective patient questionnaires filled out at each follow-up visit
Time Frame
2-5 years
Title
Ipsilateral breast event
Description
Track occurrence and patterns of local treatment failures or new primaries within the treated breast (efficacy outcome measure)
Time Frame
5-15 years
Title
Cause specific survival
Description
Track survival status and the specific cause(s) of death if applicable for study participants (efficacy outcome measure)
Time Frame
5-15 years
Title
Disease free survival
Description
Track breast-cancer free survival status of study participants (efficacy outcome measure)
Time Frame
5-15 years
Title
Overall survival
Description
Track the overall survival status of all study participants (efficacy outcome measure)
Time Frame
5-15 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rachel Lei, BS
Phone
303-418-7607
Email
rachel.lei@usoncology.com
First Name & Middle Initial & Last Name or Official Title & Degree
Charles Leonard, MD
Phone
303-730-4700
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charles Leonard, MD
Organizational Affiliation
Rocky Mountain Cancer Centers
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rocky Mountain Cancer Centers - Aurora
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80012
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dennis Carter, MD
First Name & Middle Initial & Last Name & Degree
William Daniel, MD
First Name & Middle Initial & Last Name & Degree
Kathryn Howell, MD
Facility Name
Rocky Mountain Cancer Centers - Boulder
City
Boulder
State/Province
Colorado
ZIP/Postal Code
80303
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrew Antell, MD
First Name & Middle Initial & Last Name & Degree
Meera Patel, MD
First Name & Middle Initial & Last Name & Degree
Ralph Wright, MD
Facility Name
Rocky Mountain Cancer Centers - Lakewood
City
Lakewood
State/Province
Colorado
ZIP/Postal Code
80228
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ralph Wright, MD
First Name & Middle Initial & Last Name & Degree
Charles Leonard, MD
Facility Name
Rocky Mountain Cancer Centers - Littleton
City
Littleton
State/Province
Colorado
ZIP/Postal Code
80120
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Charles Leonard, MD
First Name & Middle Initial & Last Name & Degree
Kathryn Howell, MD
Facility Name
Rocky Mountain Cancer Centers - Thornton
City
Thornton
State/Province
Colorado
ZIP/Postal Code
80260
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robert LaPorte, MD
First Name & Middle Initial & Last Name & Degree
Daniel Chin, MD
12. IPD Sharing Statement
Citations:
PubMed Identifier
34469056
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.
Results Reference
derived
Learn more about this trial
Intensity Modulated Radiotherapy (IMRT) vs. 3D-conformal Accelerated Partial Breast Irradiation (APBI) for Early Stage Breast Cancer After Lumpectomy
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