Phase II Multi-center Trial Evaluating 5 Fraction Stereotactic Partial Breast Irradiation Using Gammapod

NCT03581136 | Active Not Recruiting DMC FDA Device

• 1 other identifier: STU 042018-083
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Patient Cosmesis

  To determine the 3 year patient overall global cosmesis score (on scale excellent, good, fair, or poor) and adverse cosmesis using SPBI with the GammPod using a 5 fraction escalated dose regimen (a more hypofractionated regimen compared to conventional APBI regimens). Cosmesis will be determined using patient cosmesis.

  3 Years

Secondary Outcomes (8)

• Ipsilateral Breast Recurrence Rate

  3 Years

• Disease Specific Survival

  3 Years

• Distant Disease-Free Interval

  3 Years

• Recurrence Free Survival

  3 Years

• Treatment Related Toxicity

  18 Months

Other Outcomes (2)

• Health-Related Quality of Life Using EQ-5D

  5 years

• Quality of Life Using BREAST-Q

  5 Years

Study Arms (1)

Prescription Isodose Surface Coverage

EXPERIMENTAL

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.

Device: Dose Fractionation

Interventions

Dose Fractionation DEVICE

Patients will receive 5 fractions of radiation. These should not be on consecutive days. At least 40 hours between each fraction and a maximum of 21 days to complete, i.e.: Tuesday, Thursday, Monday, Wednesday, Friday.

Prescription Isodose Surface Coverage

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Men are not eligible for this study.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women who satisfy all of the following conditions will be eligible for this study.
• DCIS or invasive ductal, medullary, papillary, mucinous (colloid), lobular,or tubular histologies.
• \. Age ≥ 18 years. 3. ECOG Performance status 0-2. 4. Women of child-bearing potential must agree to use adequate contraception (barrier method of birth control- condom or diaphragm and spermicidal foam; intrauterine device, prescription birth control pills, or abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
• A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
• Has not undergone a hysterectomy or bilateral oophorectomy; or
• Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).
• \. Appropriate staging studies identifying as AJCC stage Tis, or T1-T2, N0 (N0i+). The tumor size must be 3 cm or less.
• \. Surgical treatment of the breast with lumpectomy with histologically confirmed margins free of tumor (no ink on margin) for invasive disease, and at least 2mm for Ductal Carcinoma In Situ.. (Re-excision of margins is permitted).
• \. Gross disease within the breast must be unifocal. (Patients with microscopic multifocality are eligible as long as the total extent of tumor, gross and microscopic, occupies a volume with greatest dimension extent of 3 cm or less (regarding the largest diameter of volume occupying space).
• \. Patients with invasive disease are required to have axillary staging including: sentinel node biopsy or axillary dissection. If patients are over age 65, axillary staging is at the discretion of the physician. Patients with DCIS are not required to have axillary staging.
• \. Lymphovascular invasion is allowed if limited or focal.
• \. Ability to understand and the willingness to sign a written informed consent

You may not qualify if:

• Men are not eligible for this study.
• T2(\>3.0 cm), T3, N1, stage III, or stage IV breast cancer
• Evidence by physical examination or mammography of other suspicious masses, densities, or microcalcifications in either breast, unless biopsied and found to be benign.
• Patients with non-epithelial breast malignancies such as sarcoma or lymphoma are excluded.
• Paget's disease of the nipple.
• Previous thoracic or breast radiation on ipsilateral side. Contralateral breast radiation is not excluded.
• Treatment plan that includes ipsilateral whole breast or ipsilateral regional nodal irradiation.
• Any prior treatment with radiation, or chemotherapy (in the neoadjuvant setting) for currently diagnosed breast cancer prior to GammaPod treatment- adjuvant chemotherapy is acceptable.
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, immunosuppressed patients or psychiatric illness/social situations that would limit compliance with study requirements.
• Subjects must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.
• If the lumpectomy cavity is completely outside of the vacuum assisted breast cup, then patient should not be treated on the GammaPod secondary to concerns of reproducibility.
• Transplant patients or any patients on immunosuppressive therapy.
• Breast size that is too large for the breast cup immobilization device.

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (2)

University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

Location

UT Southwestern Medical Centre

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Chemical Fractionation

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Asal Rahimi, MD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: June 6, 2018
• First Posted: July 10, 2018
• Study Start: April 22, 2019
• Primary Completion (Estimated): May 25, 2028
• Study Completion (Estimated): June 28, 2030
• Last Updated: September 29, 2025

Record last verified: 2025-09

Locations

US (2)