Phase II Multi-center Trial Evaluating 5 Fraction Stereotactic Partial Breast Irradiation Using Gammapod
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|ClinicalTrials.gov Identifier: NCT03581136|
Recruitment Status : Active, not recruiting
First Posted : July 10, 2018
Last Update Posted : November 29, 2021
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Device: Dose Fractionation||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||74 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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.
- 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.
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 ClinicalTrials.gov identifier (NCT number): NCT03581136
|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|
|Principal Investigator:||Asal Rahimi, MD||UT Southwestern Medical Center|