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New treatment option for Breast Cancer
Official title Intensity Modulated Radiotherapy (IMRT) vs. 3D-conformal Accelerated Partial Breast Irradiation (APBI) for Early Stage Breast Cancer After Lumpectomy
ClinicalTrials.gov ID: NCT01185132
What this study is testing
- What it's testing
- 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.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 and older
You may be able to join 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.
- people with infiltrating lobular histologies or high nuclear grade DCIS will be required to have breast MRI scanning as part of the initial staging...
- people with DCIS will be included in the study only if they had an MRI prior to lumpectomy.
You likely can't join if
- Pregnancy or breast-feeding.
- Have collagen-vascular disease.
- Inadequate surgical margins ( \< 0.2 cm) after final surgery.
- people with persistent malignant/suspicious micro-calcifications.
- Gross multifocal disease and microscopic disease greater than 3.0 cm.
See the full eligibility 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.
- people 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.
- people 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.
- people 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.
- Pregnancy or breast-feeding.
- Have collagen-vascular disease.
- Inadequate surgical margins ( \< 0.2 cm) after final surgery.
- people with persistent malignant/suspicious micro-calcifications.
- Gross multifocal disease and microscopic disease greater than 3.0 cm.
The study team makes the final eligibility decision.
Where it's taking place
- Aurora, Colorado, United States
- Boulder, Colorado, United States
- Lakewood, Colorado, United States
- Littleton, Colorado, United States
- Thornton, Colorado, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Aurora, Colorado, United States; Boulder, Colorado, United States; Lakewood, Colorado, United States; Littleton, Colorado, United States; Thornton, Colorado, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.