Breast Cancer Clinical Trial
— 2009-APBIOfficial title:
A Phase III Randomized Study Comparing Intensity Modulated Planning Versus 3-Dimensional Planning for Accelerated Partial Breast Radiotherapy
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.
Status | Recruiting |
Enrollment | 660 |
Est. completion date | July 2028 |
Est. primary completion date | July 2018 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 40 Years and older |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Rocky Mountain Cancer Centers - Aurora | Aurora | Colorado |
United States | Rocky Mountain Cancer Centers - Boulder | Boulder | Colorado |
United States | Rocky Mountain Cancer Centers - Lakewood | Lakewood | Colorado |
United States | Rocky Mountain Cancer Centers - Littleton | Littleton | Colorado |
United States | Rocky Mountain Cancer Centers - Thornton | Thornton | Colorado |
Lead Sponsor | Collaborator |
---|---|
Rocky Mountain Cancer Centers |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Yes |
Primary | 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 | Yes |
Secondary | 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 | 5-10 days | Yes |
Secondary | Acute skin reactions | Radiation-induced dermatitis | 6 months | Yes |
Secondary | Cosmetic outcomes after APBI | Assesed by both treating investigators and subjective patient questionnaires filled out at each follow-up visit | 2-5 years | No |
Secondary | Ipsilateral breast event | Track occurrence and patterns of local treatment failures or new primaries within the treated breast (efficacy outcome measure) | 5-15 years | No |
Secondary | Cause specific survival | Track survival status and the specific cause(s) of death if applicable for study participants (efficacy outcome measure) | 5-15 years | No |
Secondary | Disease free survival | Track breast-cancer free survival status of study participants (efficacy outcome measure) | 5-15 years | No |
Secondary | Overall survival | Track the overall survival status of all study participants (efficacy outcome measure) | 5-15 years | No |
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