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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03581136
Recruitment Status : Active, not recruiting
First Posted : July 10, 2018
Last Update Posted : November 29, 2021
Information provided by (Responsible Party):
Asal Rahimi, University of Texas Southwestern Medical Center

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Device: Dose Fractionation Not Applicable

Detailed Description:

The GammaPod is a new external beam radiotherapy device dedicated for stereotactic radiotherapy of breast cancer (Xcision Medical Systems, LLC, Columbia, Maryland). The design goal of the GammaPod has been the ability to deliver ablative doses with sharp gradients under stereotactic image guidance. Highly focused radiation is achieved at the isocenter due to the cross-firing from 36 radiation arcs generated by rotating 36 individual Cobalt-60 beams.In order to immobilize the breast during imaging and treatment and in order to get a stereotactic localization of the breast target volume, a vacuum-assisted breast immobilization cup with built-in stereotactic frame is used. The patient can be imaged on a CT or MRI wearing the vacuum-assisted breast cup and then be transferred to the GammaPod for treatment. Then, the planner is required to delineate the gross tumor volume (GTV) and its subclinical extensions. Multiple targets within a breast are allowed.Different doses can be prescribed to different targets.One benefit of using the GammaPod over the cyberknife for breast SBRT, is elimination of the need for internal gold fiducial markers, which are required for the cyberknife treatment.

Using a stereotactic technique for APBI allows smaller margins in comparison to a 3DCRT technique. The total expansions on the RAPID trial (3DCRT APBI) were 1.0 cm CTV expansion on the lumpectomy cavity and an additional 1.0 cm for PTV, for a total expansion of 2.0 cm. As a 3DCRT technique was used on the RAPID trial limited number of radiation beams were employed, no Intensity Modulated Radiation Techniques allowed, and the margins used to create a PTV were relatively large (total margin 2 cm).

As the GammaPod will allow us to minimize the volume of normal breast being irradiated, and decrease the PTV volume we hypothesize that a stereotactic technique with the GammaPod will allow us to improve on the 3 year global cosmesis rates (physician and patient) reported in the RAPID trial (3DCRT) by 40% despite 5 daily fractions of SBRT (in contrast to 38.5Gy/10 fractions 3DCRT BID on the RAPID trial) The GammaPod was FDA approved 12-2017.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 74 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Multi-center Trial Evaluating 5 Fraction S-PBI (Stereotactic Partial Breast Irradiation) for Early Stage Breast Cancer Using the GammaPod
Actual Study Start Date : April 22, 2019
Estimated Primary Completion Date : May 25, 2028
Estimated Study Completion Date : June 28, 2030

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Prescription Isodose Surface Coverage

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
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.

Primary Outcome Measures :
  1. Health-Related Quality of Life (HRQOL) Analysis [ Time Frame: 5 years ]
    The quality of life questionnaire will be used as a standardized instrument to measure the health outcome.Its provides a simple descriptive profile and a single index value for health status. The US version of the EQ-5D will be used, to enable mapping of general HR-QOL scores from EQ-5D scores into health state utility scores (ranging from 0 to 100) for the US population.Analyses will be performed for all subjects having received at least one fraction of radiation.The study will use the CTCAE version 5.0 for reporting of acute and late adverse events related to breast will be reported by the physician through exam/assessment during research visit, encompassing events since last research visit. Research will collect and log breast related events for up to 5 years.

Secondary Outcome Measures :
  1. Evaluation of Cosmesis [ Time Frame: 3Years ]
    Photographs of both breasts will be taken and cosmesis will be graded by the patient, and the radiation oncologist using the EORTC scale at baseline, and twelve months from the start of therapy and at yearly intervals thereafter up to 3 years after treatment. Digital Photographs will be evaluated using the BCCT.core proprietary software developed by INESC Porto Breast Research Group (50-51) and an independent panel. Cosmesis forms using the EORTC scale will be completed by both physician and patient.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Men are not eligible for this study.
Accepts Healthy Volunteers:   No

Inclusion Criteria:

Women who satisfy all of the following conditions will be eligible for this study.

1 DCIS or invasive ductal, medullary, papillary, mucinous (colloid), lobular,or tubular histologies.

2. 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.

4.1. 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).

    5. Appropriate staging studies identifying as AJCC stage Tis, or T1-T2, N0 (N0i+). The tumor size must be 3 cm or less.

    6. 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).

    7. 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).

    8. 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.

    9. Lymphovascular invasion is allowed if limited or focal.

    10. Ability to understand and the willingness to sign a written informed consent

Exclusion Criteria:

  1. Men are not eligible for this study.
  2. T2(>3.0 cm), T3, N1, stage III, or stage IV breast cancer
  3. Evidence by physical examination or mammography of other suspicious masses, densities, or microcalcifications in either breast, unless biopsied and found to be benign.
  4. Patients with non-epithelial breast malignancies such as sarcoma or lymphoma are excluded.
  5. Paget's disease of the nipple.
  6. Previous thoracic or breast radiation on ipsilateral side. Contralateral breast radiation is not excluded.
  7. Treatment plan that includes ipsilateral whole breast or ipsilateral regional nodal irradiation.
  8. Any prior treatment with radiation, or chemotherapy (in the neoadjuvant setting) for currently diagnosed breast cancer prior to GammaPod treatment- adjuvant chemotherapy is acceptable.
  9. Patients with active collagen vascular disease, specifically dermatomyositis with a CPK level above normal or active skin rash, systemic lupus erythematosis, or scleroderma, or no other exclusions.
  10. 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.
  11. Subjects must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.
  12. 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.
  13. Transplant patients or any patients on immunosuppressive therapy.
  14. Breast size that is too large for the breast cup immobilization device.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03581136

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United States, Maryland
University of Maryland Medical Center
Baltimore, Maryland, United States, 21201
United States, Texas
UT Southwestern Medical Centre
Dallas, Texas, United States, 75390
Sponsors and Collaborators
University of Texas Southwestern Medical Center
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Principal Investigator: Asal Rahimi, MD UT Southwestern Medical Center
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Responsible Party: Asal Rahimi, MD, University of Texas Southwestern Medical Center Identifier: NCT03581136    
Other Study ID Numbers: STU 042018-083
First Posted: July 10, 2018    Key Record Dates
Last Update Posted: November 29, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases