Proton Therapy for Early Stage Breast Cancer
Study Details
Study Description
Brief Summary
The purpose of this study is to determine if partial breast proton therapy is effective treatment for early stage breast cancer following lumpectomy.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
Radiation therapy is considered standard treatment for most women with early stage breast cancer following lumpectomy. Post-lumpectomy radiotherapy is a proven treatment that reduces cancer recurrence in the breast and improves survival. When standard whole breast radiation techniques are utilized, portions of the chest wall, lung and heart may also receive significant doses of radiation which can lead to radiation induced complications. Radiation techniques that limit the treatment area to the portion of the breast where the cancer arose can minimize and even eliminate radiation dose to the chest wall, heart and lung. This is called partial breast radiotherapy. This study is designed to evaluate the use of proton beam radiotherapy to deliver partial breast radiotherapy in women with early stage breast cancer.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Proton Radiotherapy Two week course of proton radiotherapy to the breast. |
Radiation: Proton radiation therapy
Proton radiotherapy will start 2-4 weeks following surgical excision. The treatment area will include the lumpectomy site with an additional margin. Daily proton therapy will be given as an out-patient over a two week coarse.
|
Outcome Measures
Primary Outcome Measures
- Determine the survival and recurrence rates associated with partial breast proton therapy. [Every 3 months]
Secondary Outcome Measures
- To evaluate the toxicity and the cosmetic results with partial breast proton therapy. To determine the local tumor control and survival associated with partial breast proton therapy [Every 3 months]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Invasive ductal, medullary, papillary, colloid or tubular histologies
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Stages T1 or T2 (tumors < or = 3 cm) from lumpectomy specimen.
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No more then 3 positive nodes on axillary dissection or negative sentinel node.
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Negative surgical margins (>2mm)
Exclusion Criteria:
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Invasive lobular histology
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Previous chemotherapy for breast cancer
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Extensive intraductal component
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Collagen vascular disease
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Prior malignancy unless disease-free for 5 years
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Patients who are pregnant or lactating
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Loma Linda University Medical Center / James M. Slater MD Proton Treatment Center / Department of Radiation Medicine / 11234 Anderson St. | Loma Linda | California | United States | 92354 |
Sponsors and Collaborators
- Loma Linda University
Investigators
- Principal Investigator: David A. Bush, MD, Loma Linda University Department of Radiation Medicine
- Study Chair: Jerry D. Slater, MD, Loma Linda University Department of Radiation Medicine
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 53294