NCT01185132 · Rocky Mountain Cancer Centers
Intensity Modulated Radiotherapy (IMRT) vs. 3D-conformal Accelerated Partial Breast Irradiation (APBI) for Early Stage Breast Cancer After Lumpectomy
(2009-APBI)
What this study is about
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.
View original scientific description
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
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)
Time frame: 2-5 years
Assessment by both treating investigators and by subjective patient outcomes questionnaires filled out at each follow-up visit
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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 requirement
Where
- Aurora, Colorado
- Boulder, Colorado
- Lakewood, Colorado
- Littleton, Colorado
- Thornton, Colorado
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 26, 2014 · Source of record for eligibility and locations