Back to results

GammaPod Dose Escalation Radiation for Early Stage Breast Cancer

Primary Purpose

Breast Cancer

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

GammaPod Radiation

About this trial

This is an interventional treatment trial for Breast Cancer

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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).

Sites / Locations

UMMCRecruiting
Upper Chesapeake HealthRecruiting
Central Maryland Oncology CenterRecruiting
Baltimore Washington Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Arm Label

Dose Level 1: 21 Gy

Dose Level 2: 24 Gy

Dose Level 3: 27 Gy

Dose Level 4: 30 Gy

Arm Description

Participants will receive radiation therapy to the partial breast using the GammaPod technology before a lumpectomy.

Outcomes

Primary Outcome Measures

Establish the single-fraction radiation dose (MTD)

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.

Incidence of Dose-Limiting Toxicities (DLTs)

The primary endpoint is DLTs defined as one or more instances of: Surgical infection: Defined as redness that resolves on antibiotics (sometimes the surgical site may look red as a result of natural healing processes and does not resolve with antibiotics) with or without fever and/or elevated white blood cell count. The risk of infection for this surgical procedure (lumpectomy ± SLN biopsy) is <5%. Nonhealing surgical incision (>30 days). The risk is <5%. Reoperation secondary to infection/wound healing problem. Risk is <5%.

Secondary Outcome Measures

Establish a Comprehensive Safety Profile of single-fraction PBI delivered with the GammaPod

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.

Establish a Comprehensive Safety Profile of single-fraction PBI delivered with the GammaPod

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.

Establish a Comprehensive Safety Profile of single-fraction PBI delivered with the GammaPod

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.]

Rate of pathologic complete response (pCR)

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.

Rate of ipsilateral local tumor recurrence

Report ipsilateral local tumor recurrence using the Kaplan-Meier method.

Full Information

NCT ID

NCT04234386

First Posted

January 8, 2020

Last Updated

September 11, 2023

Sponsor

University of Maryland, Baltimore

1. Study Identification

Unique Protocol Identification Number

NCT04234386

Brief Title

GammaPod Dose Escalation Radiation for Early Stage Breast Cancer

Official Title

GCC 1926- Phase Ib Dose Escalation of Single-Fraction Preoperative Stereotactic Partial-Breast Irradiation for Early-Stage Breast Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Recruiting

Study Start Date

September 15, 2021 (Actual)

Primary Completion Date

December 2026 (Anticipated)

Study Completion Date

December 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Maryland, Baltimore

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Sequential Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Dose Level 1: 21 Gy

Arm Type

Active Comparator

Arm Description

Participants will receive radiation therapy to the partial breast using the GammaPod technology before a lumpectomy.

Arm Title

Dose Level 2: 24 Gy

Arm Type

Active Comparator

Arm Description

Participants will receive radiation therapy to the partial breast using the GammaPod technology before a lumpectomy.

Arm Title

Dose Level 3: 27 Gy

Arm Type

Active Comparator

Arm Description

Participants will receive radiation therapy to the partial breast using the GammaPod technology before a lumpectomy.

Arm Title

Dose Level 4: 30 Gy

Arm Type

Active Comparator

Arm Description

Participants will receive radiation therapy to the partial breast using the GammaPod technology before a lumpectomy.

Intervention Type

Radiation

Intervention Name(s)

GammaPod Radiation

Intervention Description

The basic design is a dose-escalation phase Ib study with 4 predefined dose levels. With this study treatment, participants will receive the dose level assigned treatment of radiation therapy before the lumpectomy surgery.

Primary Outcome Measure Information:

Title

Establish the single-fraction radiation dose (MTD)

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.

Time Frame

5 years

Title

Incidence of Dose-Limiting Toxicities (DLTs)

Description

Time Frame

5 years

Secondary Outcome Measure Information:

Title

Establish a Comprehensive Safety Profile of single-fraction PBI delivered with the GammaPod

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.

Time Frame

5 years

Title

Establish a Comprehensive Safety Profile of single-fraction PBI delivered with the GammaPod

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.

Time Frame

5 years

Title

Establish a Comprehensive Safety Profile of single-fraction PBI delivered with the GammaPod

Description

Time Frame

5 years

Title

Establish a Comprehensive Safety Profile of single-fraction PBI delivered with the GammaPod

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.]

Time Frame

5 years

Title

Rate of pathologic complete response (pCR)

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.

Time Frame

5 years

Title

Rate of ipsilateral local tumor recurrence

Description

Report ipsilateral local tumor recurrence using the Kaplan-Meier method.

Time Frame

5 years

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

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).

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Elizabeth Nichols, MD

Phone

410-328-6080

enichols1@umm.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Caitlin Eggleston

Phone

410-328-7586

caitlineggleston@umm.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Elizabeth Nichols, MD

Organizational Affiliation

University of Maryland, Baltimore

Official's Role

Principal Investigator

Facility Information:

Facility Name

UMMC

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21201

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Madiha M. Qutab, MS

Phone

410-328-7501

madiha.qutab@umm.edu

First Name & Middle Initial & Last Name & Degree

Elizabeth Nichols, MS

Phone

410-328-2324

enichols1@umm.edu

First Name & Middle Initial & Last Name & Degree

Elizabeth Nichols, MD

Facility Name

Upper Chesapeake Health

City

Bel Air

State/Province

Maryland

ZIP/Postal Code

21014

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Linda Romar, BS

Phone

443-643-1877

lromar@umm.edu

First Name & Middle Initial & Last Name & Degree

Jack Hong, MD

Facility Name

Central Maryland Oncology Center

City

Columbia

State/Province

Maryland

ZIP/Postal Code

21044

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Madiha Qutab, M.S.

Phone

443-328-6472

madiha.qutab@umm.edu

First Name & Middle Initial & Last Name & Degree

Sally Cheston, MD

Facility Name

Baltimore Washington Medical Center

City

Glen Burnie

State/Province

Maryland

ZIP/Postal Code

21061

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Pilar Strycula, RN, BSN

Phone

410-553-8110

Pstrycula@.umm.edu

First Name & Middle Initial & Last Name & Degree

Wendla Citron, MD

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

GammaPod Dose Escalation Radiation for Early Stage Breast Cancer

We'll reach out to this number within 24 hrs