Fractionated Radiation Therapy for Breast Cancer

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen byAsal Rahimi, MD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University of Texas Southwestern Medical Center

No Placebo Group

Trial Summary

What is the purpose of this trial?Stereotactic radiation has been implemented more than 3 decades ago, initially to radiate benign and later malignant tumors within the brain. Doses up to 24 Gy in one session have been used. Hundreds of thousands of patients have been treated worldwide with very good outcomes . Over the last decade, the stereotactic radiation techniques have been implemented to treat extra-cranial tumors. The challenges of extra cranial tumors were in part target motion during the radiation session, but also accurate re positioning of the patient and of the target volume at time of radiation treatment. Specific immobilization devices are now available to improve accuracy of target localization. Stereotactic radiation therapy is widely available, non-invasive for the patient and less operator dependent as the planning process (from target volume to dose calculation) can be done and verified by different operators through a quality assessment procedure. Stereotactic radiation is a complex type of 3D CRT that is a very attractive technique making the 3D CRT more conformal and more accurate delivery of the prescription dose within the target volume with a very good sparing of surrounding normal tissue. The principles of stereotactic radiation are the following: precise image definition of target volume and OARs, very conformal radiation treatment.

Eligibility Criteria

This trial is for women aged 18+ with certain types of breast cancer (like DCIS or invasive ductal) that's localized and hasn't spread. They must have had a lumpectomy with clear margins, be in good health overall, not pregnant or nursing, and willing to use contraception. It excludes those with large breasts for the device, prior chest radiation, advanced cancer stages, immunosuppression issues, or other serious illnesses.

Inclusion Criteria

I have a specific type of breast cancer.

I can take care of myself and am up and about more than half of the day.

My breast cancer is located in just one area.

+7 more

Exclusion Criteria

I have suspicious breast findings not confirmed as benign by biopsy.

I have had radiation therapy on the same side as my current cancer.

I have had radiation or chemotherapy for my current breast cancer before GammaPod treatment.

+11 more

Participant Groups

The trial tests a precise form of stereotactic partial breast irradiation called GammaPod on patients who've had surgery for early-stage breast cancer. It aims to deliver high doses of radiation accurately to the affected area while sparing healthy tissue.

1Treatment groups

Experimental Treatment

Group I: Prescription Isodose Surface CoverageExperimental Treatment1 Intervention

The dose fractionation to the CTV (1cm expansion on cavity) will be 40Gy/ 5 fractions and the PTV (3 mm expansion of CTV) will be a minimum dose of 30Gy/5 fractions. If PTV \>100cc or if dose constraints cannot be met on higher dose prescribe CTV (1.0cm) to 35Gy/5 fractions and PTV (3mm) to 30Gy/5 fractions. This is to potentially reduce risk of fat necrosis.