Study Comparing Two Types of Radiation Therapy for Early Stage Breast Cancer After Lumpectomy

Sponsor: Rocky Mountain Cancer Centers

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT01185132

Provider View

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

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.

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.