Stereotactic Image-Guided Neoadjuvant Ablative Radiation Then Lumpectomy

Official Title

A Phase II Trial to Evaluate Single Dose Stereotactic Radiation Therapy (SBRT) Prior to Surgery for Early Stage Breast Carcinoma

Summary:

Radiation therapy after surgery to remove breast cancer improves control of the breast cancer. Standard therapy after breast conservation surgery is five to six weeks of radiation to the entire breast. This clinical trial will evaluate the effectiveness of conformal radiation therapy delivered only to the area in the breast where the lumpectomy will be performed. This study will determine if radiation therapy delivered in this manner will prevent the cancer from coming back and eliminate the need for five to six weeks of radiation. The study will also gather information about the safety and effects (good and bad) this radiation has, and on patient satisfaction with the appearance of the breast.

Trial Description

Primary Outcome:

• Toxicity resulting from radiation treatment

Secondary Outcome:

• Cosmesis of the treated breast
• Disease-Free Survival
• Mastectomy-Free Survival
• Overall Survival

Our proposal represents the convergence of several recent developments in the treatment of patients with low-risk carcinoma of the breast. For the selected subset of patients with low-risk disease, it appears that intra-operative radiation therapy with a single fraction leads to acceptable clinical outcomes in terms of local control, overall survival and toxicity. There have also been a few Phase I dose escalation trials demonstrating safety with single fraction breast radiation. In this study, we propose the delivery of radiation therapy using only a single fraction, 21 Gy, but using stereotactic body radiation therapy. Radiation will be delivered using Volumetric-modulated arc therapy (VMAT), planned on coregistered PET/MRI and CT imaging, and delivered prone. Our approach will potentially have numerous benefits, including significantly shortened treatment time, convenience and potentially reduced health care costs. It would significantly improve the quality of life of many patients. This study will also provide a unique opportunity for pathologic assessment of the impact of radiation at a microscopic level and on tumour markers without the confounding impact of systemic treatments, comparing pre- to post-radiation biopsy specimens for imaging and histologic predictors of radiation sensitivity.

View this trial on ClinicalTrials.gov