Clinical Trials /

GammaPod Dose Escalation Radiation for Early Stage Breast Cancer

NCT04234386

Description:

The GammaPod machine was made by Xcision Medical Systems and is already FDA cleared to deliver focused radiation within the breast. Unlike current radiation machines, the GammaPod was designed specifically for treating breast cancer. The GammaPod can pinpoint radiation to the tumor bed in the breast which lowers the amount of radiation to nearby tissues. The machine uses a breast cup system to hold the breast in place for the treatment. This breast cup system was tested at MSGCCC (Marlene Stewart Greenebaum Comprehensive Cancer Center). Patients reported this system was more comfortable than an MRI or mammogram. The cup system was able to securely position the breast for treatment in the correct location. Receiving radiation before surgery is not a new concept in cancer management. Preoperative radiation has proven to result in improved disease free survival in certain types of cancer. With this study treatment, the participants will receive a dose of breast radiation therapy before the lumpectomy surgery. The lumpectomy surgery is where they remove the participant's tumor. The purpose of this research study is to determine a safe and effective dose of pre-operative radiation to treat early stage breast cancer. The pre-operative radiation is delivered using the FDA approved, GammaPod machine. The study will also determine the cosmesis of pre-operative radiation at different doses. Cosmesis is another word for looking at skin changes. The research team will use questionnaires for patient and physicians to assess adverse cosmesis changes as accurately as possible. In addition, the investigators are going to assess radiation related changes using photo software analysis tools and patients quality of life.

Related Conditions:
  • Breast Invasive Ductal Carcinoma
Recruiting Status:

Recruiting

Phase:

N/A

Trial Eligibility

Document

Title

  • Brief Title: GammaPod Dose Escalation Radiation for Early Stage Breast Cancer
  • Official Title: Phase Ib Dose Escalation of Single-Fraction Preoperative Stereotactic Partial-Breast Irradiation for Early-Stage Breast Cancer

Clinical Trial IDs

  • ORG STUDY ID: GCC 1926
  • NCT ID: NCT04234386

Conditions

  • Breast Cancer

Purpose

The GammaPod machine was made by Xcision Medical Systems and is already FDA cleared to deliver focused radiation within the breast. Unlike current radiation machines, the GammaPod was designed specifically for treating breast cancer. The GammaPod can pinpoint radiation to the tumor bed in the breast which lowers the amount of radiation to nearby tissues. The machine uses a breast cup system to hold the breast in place for the treatment. This breast cup system was tested at MSGCCC (Marlene Stewart Greenebaum Comprehensive Cancer Center). Patients reported this system was more comfortable than an MRI or mammogram. The cup system was able to securely position the breast for treatment in the correct location. Receiving radiation before surgery is not a new concept in cancer management. Preoperative radiation has proven to result in improved disease free survival in certain types of cancer. With this study treatment, the participants will receive a dose of breast radiation therapy before the lumpectomy surgery. The lumpectomy surgery is where they remove the participant's tumor. The purpose of this research study is to determine a safe and effective dose of pre-operative radiation to treat early stage breast cancer. The pre-operative radiation is delivered using the FDA approved, GammaPod machine. The study will also determine the cosmesis of pre-operative radiation at different doses. Cosmesis is another word for looking at skin changes. The research team will use questionnaires for patient and physicians to assess adverse cosmesis changes as accurately as possible. In addition, the investigators are going to assess radiation related changes using photo software analysis tools and patients quality of life.

Trial Arms

NameTypeDescriptionInterventions
Dose Level 1: 21 GyActive ComparatorParticipants will receive radiation therapy to the partial breast using the GammaPod technology before a lumpectomy.
    Dose Level 2: 24 GyActive ComparatorParticipants will receive radiation therapy to the partial breast using the GammaPod technology before a lumpectomy.
      Dose Level 3: 27 GyActive ComparatorParticipants will receive radiation therapy to the partial breast using the GammaPod technology before a lumpectomy.
        Dose Level 4: 30 GyActive ComparatorParticipants will receive radiation therapy to the partial breast using the GammaPod technology before a lumpectomy.

          Eligibility Criteria

                  Inclusion Criteria:
          
                    -  Patients must sign consent for study participation.
          
                    -  Patients must be female with a diagnosis of invasive ductal carcinoma. Lobular
                       histologies will not be included, because of difficulty in defining the extent of
                       disease with imaging.
          
                    -  Patients must be deemed appropriate candidates for breast-conserving therapy (i.e.,
                       not pregnant, never had RT to the treated breast, breast size would allow adequate
                       cosmesis after volume loss from partial mastectomy).
          
                    -  Tumor must not involve the overlying skin or underlying chest wall, based on imaging
                       evaluation and/or clinical exam.
          
                    -  Greatest tumor dimension is <3 cm based on US. MR imaging measurements can be included
                       only if performed BEFORE the biopsy (postbiopsy measurements can be larger as a result
                       of hematoma formation or increased edema).
          
                    -  Tumor must be unifocal.
          
                    -  Patients must be > 45 years old.
          
                    -  The tumor must be visible on a CT scan.
          
                    -  Patients must undergo MR imaging for work-up to aid in tumor delineation and to rule
                       out additional foci of disease. If additional foci of disease are found to be present,
                       then these must be biopsied with negative results to proceed with treatment.
          
                    -  The tumor must be clinically and radiographically N0 (node negative). If a suspicious
                       node is visualized, it must be biopsied with negative results.
          
                    -  Patients must be estrogen-receptor positive.
          
                    -  Patients must be HER2neu negative.
          
                    -  Patients must weigh <150 kg (330 lb), which is the limit of the imaging loader.
          
                    -  Patients must be <6'6" in height, again because of instrumentation limitations.
          
                    -  Patients must be able to lie prone for treatment.
          
                    -  Patients must have no lymphovascular invasion on biopsy.
          
                    -  Patients may be taking hormonal therapy prior to initiation of treatment. This will be
                       documented.
          
                  Exclusion Criteria:
          
                    -  Multicentric disease.
          
                    -  Prior RT to the involved breast.
          
                    -  Inability to fit into the immobilization breast cup because of breast size or other
                       anatomic reasons.
          
                    -  Inability to obtain an adequate seal when using the immobilization breast cup.
          
                    -  Male sex.
          
                    -  Breast implants.
          
                    -  Patient cannot comfortably lie in the prone position (i.e., physical disability).
          
                    -  Patients who are planned to be treated surgically with a mastectomy.
          
                    -  Tumor <5 mm from the skin surface or chest wall on clinical exam and/or radiographic
                       imaging.
          
                    -  Tumor size >3 cm.
          
                    -  Patients with psychiatric or addictive disorders that would preclude obtaining
                       informed consent or study completion.
          
                    -  Patients who are pregnant or lactating (because of potential RT exposure to the fetus
                       and unknown effects of RT in lactating women).
          
                    -  Patient unable to undergo MR imaging (e.g., because of known contrast reaction or
                       concerns about contrast and existing health status).
          
                    -  Lymphovascular invasion on original biopsy.
          
                    -  Tumor histologies other than invasive ductal carcinoma (including invasive lobular
                       carcinoma).
          
                    -  ER-negative tumors.
          
                    -  HER2neu-positive tumors.
          
                    -  Pure ductal carcinoma in situ (no invasive component).
          
                    -  Weight >330 lb
          
                    -  Prior ipsilateral breast cancer.
          
                    -  Diffuse calcifications on mammogram (BIRADS 3, 4, 5).
                
          Maximum Eligible Age:N/A
          Minimum Eligible Age:45 Years
          Eligible Gender:Female
          Healthy Volunteers:No

          Primary Outcome Measures

          Measure:Establish the single-fraction radiation dose (MTD)
          Time Frame:5 years
          Safety Issue:
          Description:To establish the single-fraction radiation dose (MTD) delivered with the GammaPod that causes an incidence of dose-limiting toxicities (DLTs) that is statistically significantly 10% or lower.

          Secondary Outcome Measures

          Measure:Establish a Comprehensive Safety Profile of single-fraction PBI delivered with the GammaPod
          Time Frame:5 years
          Safety Issue:
          Description:To establish the comprehensive safety profile of single-fraction PBI delivered with the GammaPod. The following secondary toxicity and quality-of-life endpoints will be collected and reported: Acute toxicity (NCI-CTCAE v 5), including skin toxicity and fatigue. Late toxicity (NCI-CTCAE v 5), including rates of fat necrosis.
          Measure:Establish a Comprehensive Safety Profile of single-fraction PBI delivered with the GammaPod
          Time Frame:5 years
          Safety Issue:
          Description:To establish the comprehensive safety profile of single-fraction PBI delivered with the GammaPod. The following secondary toxicity and quality-of-life endpoints will be collected and reported: -Rates of surgical morbidity (defined below), including seroma formation. Seroma will be defined as any palpable seroma on follow-up exam. If seroma results in pain/discomfort and/or requires drainage this should be noted as a 'symptomatic' seroma. Seroma formation is normal following lumpectomy surgery but is asymptomatic in the majority of cases.
          Measure:Establish a Comprehensive Safety Profile of single-fraction PBI delivered with the GammaPod
          Time Frame:5 years
          Safety Issue:
          Description:To establish the comprehensive safety profile of single-fraction PBI delivered with the GammaPod. The following secondary toxicity and quality-of-life endpoints will be collected and reported: -Patient and physician-assessed cosmesis after radiotherapy and surgery via questionnaire.
          Measure:Establish a Comprehensive Safety Profile of single-fraction PBI delivered with the GammaPod
          Time Frame:5 years
          Safety Issue:
          Description:To establish the comprehensive safety profile of single-fraction PBI delivered with the GammaPod. The following secondary toxicity and quality-of-life endpoints will be collected and reported: - Patient Quality of Life Assessments [EORTC QLQ-C30- scale goes from 1/not at all to 4/very much. There is additionally a rate of overall health and quality of life that is a scale from 1 to 7.]
          Measure:Rate of pathologic complete response (pCR)
          Time Frame:5 years
          Safety Issue:
          Description:To establish the rate of pathologic complete response (pCR) as a function of dose. pCR will be scored by pathology review of H&E slides.
          Measure:Rate of ipsilateral local tumor recurrence
          Time Frame:5 years
          Safety Issue:
          Description:Report ipsilateral local tumor recurrence using the Kaplan-Meier method.

          Details

          Phase:N/A
          Primary Purpose:Interventional
          Overall Status:Recruiting
          Lead Sponsor:University of Maryland, Baltimore

          Last Updated

          October 15, 2020