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

Sponsor: Rocky Mountain Cancer Centers

Sponsor score: 0

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

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

FACILITYZIPCITYSTATE
Rocky Mountain Cancer Centers - Aurora80012AuroraColorado
Rocky Mountain Cancer Centers - Boulder80303BoulderColorado
Rocky Mountain Cancer Centers - Lakewood80228LakewoodColorado
Rocky Mountain Cancer Centers - Littleton80120LittletonColorado
Rocky Mountain Cancer Centers - Thornton80260ThorntonColorado

Get This Program In Your Inbox

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