NCT01185132 Intensity Modulated Radiotherapy (IMRT) vs. 3D-conformal Accelerated Partial Breast Irradiation (APBI) for Early Stage Breast Cancer After Lumpectomy
| NCT ID | NCT01185132 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Rocky Mountain Cancer Centers |
| Condition | Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 660 participants |
| Start Date | 2009-07 |
| Primary Completion | 2018-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 660 participants in total. It began in 2009-07 with a primary completion date of 2018-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Charles Leonard, MD
PRINCIPAL INVESTIGATOR
Rocky Mountain Cancer Centers
Frequently Asked Questions
Who can join the NCT01185132 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT01185132 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 660 participants.
Is NCT01185132 currently recruiting?
Yes, NCT01185132 is actively recruiting participants. Contact the research team at rachel.lei@usoncology.com for enrollment information.
Where is the NCT01185132 trial being conducted?
This trial is being conducted at Aurora, United States, Boulder, United States, Lakewood, United States, Littleton, United States and 1 additional location.
Who is sponsoring the NCT01185132 clinical trial?
NCT01185132 is sponsored by Rocky Mountain Cancer Centers. The principal investigator is Charles Leonard, MD at Rocky Mountain Cancer Centers. The trial plans to enroll 660 participants.
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