Study Comparing Two Types of Radiation Therapy for Early Stage Breast Cancer After Lumpectomy
Sponsor: Rocky Mountain Cancer Centers
ClinicalTrials ID:NCT01185132
This clinical trial is comparing two methods of delivering radiation therapy to see which is more effective and safer for patients with early stage breast cancer who have had a lumpectomy. The study focuses on whether a newer method, intensity modulated radiotherapy (IMRT), can better protect healthy breast and lung tissue compared to the standard 3D-conformal radiation therapy.
Patient Parameters
| Parameter | Options |
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Program Overview
The study aims to determine if intensity modulated radiotherapy (IMRT) is a better option than the standard 3D-conformal radiation therapy for patients with early stage breast cancer who have undergone a lumpectomy. IMRT is a newer technique that may spare more healthy breast and lung tissue, potentially leading to better outcomes for patients.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with early stage breast cancer, specifically Tis, T1, or T2 (tumor size 3.0 cm or smaller), with no spread to lymph nodes or other parts of the body.
- If the cancer is found in multiple small areas, the total size must be 3.0 cm or less.
- Clear surgical margins of at least 0.2 cm after surgery.
- Patients with certain types of breast cancer or high-grade DCIS must have an MRI to confirm the cancer is localized.
- Patients with DCIS must have had an MRI before their lumpectomy.
- Any suspicious findings on MRI outside the planned surgery area should be checked with an ultrasound and possibly a biopsy.
- Patients with cancerous calcifications on a mammogram must have another mammogram after surgery to ensure all calcifications are removed.
- Willing to undergo additional screening and meet the study's eligibility requirements.
- Successful placement of markers needed for image-guided radiation therapy.
- The planned treatment area should not exceed 25% of the affected breast.
- Radiation therapy should start within 10 weeks after surgery.
Exclusion Criteria
- Pregnant or breastfeeding women.
- Have a condition called collagen-vascular disease.
- Surgical margins less than 0.2 cm after surgery.
- Persistent cancerous or suspicious calcifications.
- Cancer spread to multiple areas or microscopic disease larger than 3.0 cm.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Rocky Mountain Cancer Centers - Aurora | 80012 | Aurora | Colorado |
| Rocky Mountain Cancer Centers - Boulder | 80303 | Boulder | Colorado |
| Rocky Mountain Cancer Centers - Lakewood | 80228 | Lakewood | Colorado |
| Rocky Mountain Cancer Centers - Littleton | 80120 | Littleton | Colorado |
| Rocky Mountain Cancer Centers - Thornton | 80260 | Thornton | Colorado |
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