Breast CancerNCT02507960
The Gamma Pod: A Clinical Feasibility Study Device GCC 1202: The Gamma Pod: A Clinical Feasibility Study
A study testing The Gamma Pod and CT simulation in people with Breast Cancer, run by University of Maryland, Baltimore at 4 sites in United States.
Trial summary
In this study, investigators plan to deliver a 8 Gy Tumor Bed (TB) boost using the Gamma Pod™ system followed by a conventional (50Gy in 25 fractions) or hypofractionated (40Gy in 15 fractions) course of whole breast radiation. Read more about this study
- Who is it for?
- Ages 60 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- The Gamma Pod and CT simulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 4 sitesUnited States
- Study dates
- Jan 2016to 9 Aug 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient must sign consent for study participation.
- The patient must be female and have a diagnosis of an invasive or non-invasive breast cancer that was treated surgically by a partial mastectomy.
- The patient must be deemed an appropriate candidate for breast conserving therapy (i.e. not pregnant, never had radiation to the treated breast, breast size would allow adequate cosmesis after volume loss from partial mastectomy).
- Patients with involved lymph nodes are candidates for the study as long as regional nodal radiation is not required by the treating physician.
- Surgical margins are negative for invasive or non-invasive breast cancer.
- The greatest dimension of the tumor is less than 4cm before surgery.
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- The volume of the TB CTV is less than 25% of the whole breast PTV which is a criteria used for partial breast alone trials (NSABP B-39).
- Multifocal disease is allowed if it was removed by a single lumpectomy resection and the patient remained a candidate for breast conservation.
- Age 60 years and older.
- Women of childbearing potential must use an effective contraceptive method such as condom/diaphragm and spermicidal foam, intrauterine device (IUD), or prescription birth control pills.A negative pregnancy test must be obtained prior to study enrollment or waiver signed.
- The surgical cavity is clearly visible on CT images.
- The patient must weigh less than 150Kg (330lb), which is the limit of the imaging couch.
- The patient must feel comfortable in the prone position.
Who cannot join
- Patients with proven multicentric carcinoma (tumors in different quadrants of the breast or tumor separated by at least 4 cm).
- Prior radiation therapy above the umbilicus
- Unable to fit into the immobilization breast cup with an adequate seal
- Male gender.
- Patient cannot comfortably be set up in the prone position (i.e. physical disability)
- Unable to fit into the breast immobilization device due to breast size or other anatomical reason.
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- Mastectomy is the surgery performed.
- Patient has received prior radiotherapy to the involved breast.
- Regional nodal irradiation is part of the treatment plan.
- Tumor bed is less than 5 mm from the skin surface.
- Patients with skin involvement, regardless of tumor size.
- Patients with connective tissue disorders specifically systemic lupus erythematosis, scleroderma, or dermatomyositis.
- Patients with psychiatric or addictive disorders that would preclude obtaining informed consent.
- Patients who are pregnant or lactating due to potential exposure of the fetus to RT and unknown effects of RT to lactating females.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Ummc Msgccc
Baltimore, Maryland, 21201
Upper Chesapeake Health
Bel Air, Maryland, 21014
Central Maryland Oncology Center
Columbia, Maryland, 21044
Baltimore Washington Medical Center
Glen Burnie, Maryland, 21061
About this study
Official title: (GCC 1202): Tumor Bed Dose Delivery Using a Breast Specific Radiosurgery Device. The Gamma Pod : A Clinical Feasibility Study
In this study, investigators plan to deliver a 8 Gy Tumor Bed (TB) boost using the Gamma Pod™ system followed by a conventional (50Gy in 25 fractions) or hypofractionated (40Gy in 15 fractions) course of whole breast radiation. The clinical target volume receiving 8 Gy will be the surgical cavity as defined by the surgical clips and post-surgical changes + 5 mm. The planning target volume (PTV) will add 5 mm to the clinical target volume to account for geometric uncertainties.
Read the detailed description
The current standard of care in our clinic when delivering a conventional course of whole breast radiation is to deliver between 60 and 66 Gy to the tumor bed when negative margins are achieved, with the initial ~45-50 Gy delivered to the whole breast and the 10-16 Gy TB boost delivered in 5-8 fractions.The current standard of care in our clinic when delivering a hypofractionated course of whole breast radiation is to deliver between 50 and 52 Gy to the tumor bed when negative margins are achieved, with the initial ~40-42.5 Gy delivered to the whole breast in 15 or 16 fractions respectively followed 10 Gy TB boost delivered in 4 or 5 fractions (total 20). The clinical target volume for the TB boost in this study is quite similar to conventional TB boost. The only difference is that the planning target volume margin is smaller in this study (5 mm instead of 10 mm) due to the reduced set up uncertainties with the breast cup immobilization and localization devices. The current institutional standard is covering the TB + 15 mm dosimetric margin. Since the reproducibility is improved by 5 mm with the aid of the breast immobilization cup, the TB + 10 mm dosimetric margin will be used on this study. Using the radiobiological equivalent dose (BED) formula, {BED = n D(1 + D/(α/β))}, the 8 Gy single fraction dose is equivalent to 16 Gy delivered in 8 fractions. Wherein the BED formula, n is the number of fractions, D is the dose per fraction and α/β is estimated to be between 3 and 4. On this study, the investigators will deliver either 40 Gy in fifteen (15) fractions (hypofractionated) or 50Gy in twenty-five (25) fractions (conventional) to the whole breast following a single 8 Gy boost using the Gamma Pod™. The summed dose to the boost region will be radiobiologically equivalent to a total dose of 52 (hypofractionated) or 66 Gy (conventional).
The safety and feasibility of delivering the boost dose to the tumor bed using a single fraction external beam is supported by past clinical trials. Besides the use of electrons and external beam from a linear accelerator, intracavitary balloons and intraoperative x-rays and electron beams have also been used to deliver a Tumor Bed (TB) boost. In the T A R G I T trial, a single dose of 20 Gy is delivered to the TB using the Intrabeam™ device while the dose drops to between 5 and 7 Gy 1 cm into the normal breast. With long term follow up (median follow-up of 60.5 months), the 5- year local recurrence rate was less than 2 %. In the largest intraoperative electron experience, investigators delivered 9 to 10 Gy in a single treatment prior to whole breast radiation using 9 (million electron volts) electrons. Long-term local control rates and cosmesis appear similar to or better than more conventional techniques. In this proposed study, the investigators plan to deliver 8 Gy to the TB rather than 20 Gy with low energy x-rays or 9-10 Gy with electrons before whole breast irradiation, based on 1) there is no benefit of dose escalation over the biological equivalent dose of 16 Gy at 2 Gy per fraction which is equal to 8 Gy in 1 fraction and 2) known increased side effects with higher doses to the tumor bed. The investigators believe that the proposed dose should be similarly tolerated as observed in these trials, since the volume of normal breast irradiated is similar using a lower dose. In addition, this treatment will similarly shorten treatment by 1 to 1½ weeks by replacing the 8 treatments to the TB.
- Conditions
- Breast Cancer
- Being tested
- The Gamma Pod, CT simulation
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Gamma PodDevice
Immobilization of breast during radiation.
CT simulationDevice
See arm description
| Study group | Role | What they receive |
|---|---|---|
| Pilot Study | Other | The patient will undergo a conventional CT simulation in supine position without the breast immobilization cup. The purpose of the CT simulation is-two-fold: 1) the investigators will see if the TB volume can be accurately delineated and if the TB volume is too large for Gamma Pod boost; and 2) the CT images are used for planning the patient's whole breast irradiation. If, after viewing the CT images and the patient is deemed a study candidate and consents, the participants will receive a second CT-sim and the Gamma Pod TB boost treatment on the same day as described below. Receives: Device: The Gamma Pod; Device: CT simulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Demonstration of the Feasibility and Safety of Delivering a Radiation Treatment Using the GammaPod (TM)
Patients must be undergoing breast conserving therapy and PI will evaluate for feasibility by ensuring coverage of the target volume with appropriate dose homogeneity and conformity as defined in the study. Per inclusion criteria, the volume of the tumor bed clinical target volume (CTV) is less than 25% of the whole breast planning target volume (PTV) which is a criteria used for partial breast alone trials (ie. NSABP B-39). If the tumor bed cannot fit this criteria, then patient is unable to be treated utilizing GammaPod.
Measured: 1 year
Secondary outcomes (3)
Number of Participants With Acute Toxicities Measured by Common Terminology Criteria for Adverse Events (CTCAE); The Evaluation of Acute Toxicity During and up to 1 Month After Gamma Pod TB Boost.
Measured: 2 months
Number of Participants With Long-term Toxicities Measured by Common Terminology Criteria for Adverse Events (CTCAE); The Evaluation of Long-term Toxicity at One Year to Assess the Presence of Subcutaneous Fibrosis and Fat Necrosis.
Measured: 1 year
Efficacy of Medical Adhesive; Number of Participants With Adverse Events From the Use of the Adhesive Spray
Adverse events from the use of the adhesive spray was measured by photos taken pre-entry and during radiation.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2015 (estimated)
- Study startJan 2016
- Primary completion30 Jun 2017
- Study completion9 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Department of Radiation Oncology, University of Maryland, Baltimore
- Investigators
- Elizabeth M Nichols, MD, Principal investigator, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02507960
- Sponsor's protocol ID
- HP-00052062
- Status last verified
- Jan 2022
- First submitted
- 16 Jul 2015
- Last updated
- 14 Jan 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- (GCC 1202): Tumor Bed Dose Delivery Using a Breast Specific Radiosurgery Device. The Gamma Pod : A Clinical Feasibility Study
- ClinicalTrials.gov ID
- NCT02507960
- Acronym / sponsor ID
- HP-00052062
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Study start
- Jan 2016 (actual)
- Primary completion
- 30 Jun 2017 (actual)
- Study completion
- 9 Aug 2018 (actual)
- First posted
- 24 Jul 2015 (estimated)
- Results
- Posted 14 Jan 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this study, investigators plan to deliver a 8 Gy Tumor Bed (TB) boost using the Gamma Pod™ system followed by a conventional (50Gy in 25 fractions) or hypofractionated (40Gy in 15 fractions) course of whole breast radiation. The clinical target volume receiving 8 Gy will be the surgical cavity as defined by the surgical clips and post-surgical changes + 5 mm. The planning target volume (PTV) will add 5 mm to the clinical target volume to account for geometric uncertainties.
Detailed description
The current standard of care in our clinic when delivering a conventional course of whole breast radiation is to deliver between 60 and 66 Gy to the tumor bed when negative margins are achieved, with the initial ~45-50 Gy delivered to the whole breast and the 10-16 Gy TB boost delivered in 5-8 fractions.The current standard of care in our clinic when delivering a hypofractionated course of whole breast radiation is to deliver between 50 and 52 Gy to the tumor bed when negative margins are achieved, with the initial ~40-42.5 Gy delivered to the whole breast in 15 or 16 fractions respectively followed 10 Gy TB boost delivered in 4 or 5 fractions (total 20). The clinical target volume for the TB boost in this study is quite similar to conventional TB boost. The only difference is that the planning target volume margin is smaller in this study (5 mm instead of 10 mm) due to the reduced set up uncertainties with the breast cup immobilization and localization devices. The current institutional standard is covering the TB + 15 mm dosimetric margin. Since the reproducibility is improved by 5 mm with the aid of the breast immobilization cup, the TB + 10 mm dosimetric margin will be used on this study. Using the radiobiological equivalent dose (BED) formula, {BED = n D(1 + D/(α/β))}, the 8 Gy single fraction dose is equivalent to 16 Gy delivered in 8 fractions. Wherein the BED formula, n is the number of fractions, D is the dose per fraction and α/β is estimated to be between 3 and 4. On this study, the investigators will deliver either 40 Gy in fifteen (15) fractions (hypofractionated) or 50Gy in twenty-five (25) fractions (conventional) to the whole breast following a single 8 Gy boost using the Gamma Pod™. The summed dose to the boost region will be radiobiologically equivalent to a total dose of 52 (hypofractionated) or 66 Gy (conventional).
The safety and feasibility of delivering the boost dose to the tumor bed using a single fraction external beam is supported by past clinical trials. Besides the use of electrons and external beam from a linear accelerator, intracavitary balloons and intraoperative x-rays and electron beams have also been used to deliver a Tumor Bed (TB) boost. In the T A R G I T trial, a single dose of 20 Gy is delivered to the TB using the Intrabeam™ device while the dose drops to between 5 and 7 Gy 1 cm into the normal breast. With long term follow up (median follow-up of 60.5 months), the 5- year local recurrence rate was less than 2 %. In the largest intraoperative electron experience, investigators delivered 9 to 10 Gy in a single treatment prior to whole breast radiation using 9 (million electron volts) electrons. Long-term local control rates and cosmesis appear similar to or better than more conventional techniques. In this proposed study, the investigators plan to deliver 8 Gy to the TB rather than 20 Gy with low energy x-rays or 9-10 Gy with electrons before whole breast irradiation, based on 1) there is no benefit of dose escalation over the biological equivalent dose of 16 Gy at 2 Gy per fraction which is equal to 8 Gy in 1 fraction and 2) known increased side effects with higher doses to the tumor bed. The investigators believe that the proposed dose should be similarly tolerated as observed in these trials, since the volume of normal breast irradiated is similar using a lower dose. In addition, this treatment will similarly shorten treatment by 1 to 1½ weeks by replacing the 8 treatments to the TB.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pilot Study | Other | Device: The Gamma Pod, Device: CT simulationThe patient will undergo a conventional CT simulation in supine position without the breast immobilization cup. The purpose of the CT simulation is-two-fold: 1) the investigators will see if the TB volume can be accurately delineated and if the TB volume is too large for Gamma Pod boost; and 2) the CT images are used for planning the patient's whole breast irradiation. If, after viewing the CT images and the patient is deemed a study candidate and consents, the participants will receive a second CT-sim and the Gamma Pod TB boost treatment on the same day as described below. |
Who may qualify
- Ages
- 60 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- The patient must sign consent for study participation.
- The patient must be female and have a diagnosis of an invasive or non-invasive breast cancer that was treated surgically by a partial mastectomy.
- The patient must be deemed an appropriate candidate for breast conserving therapy (i.e. not pregnant, never had radiation to the treated breast, breast size would allow adequate cosmesis after volume loss from partial mastectomy).
- Patients with involved lymph nodes are candidates for the study as long as regional nodal radiation is not required by the treating physician.
- Surgical margins are negative for invasive or non-invasive breast cancer.
Key exclusion criteria (14 listed)
- Patients with proven multicentric carcinoma (tumors in different quadrants of the breast or tumor separated by at least 4 cm).
- Prior radiation therapy above the umbilicus
- Unable to fit into the immobilization breast cup with an adequate seal
- Male gender.
- Patient cannot comfortably be set up in the prone position (i.e. physical disability)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The Gamma PodImmobilization of breast during radiation. | Device | Pilot Study |
| CT simulationSee arm description | Device | Pilot Study |
Primary outcome
Demonstration of the Feasibility and Safety of Delivering a Radiation Treatment Using the GammaPod (TM)
Time frame: 1 year
Patients must be undergoing breast conserving therapy and PI will evaluate for feasibility by ensuring coverage of the target volume with appropriate dose homogeneity and conformity as defined in the study. Per inclusion criteria, the volume of the tumor bed clinical target volume (CTV) is less than 25% of the whole breast planning target volume (PTV) which is a criteria used for partial breast alone trials (ie. NSABP B-39). If the tumor bed cannot fit this criteria, then patient is unable to be treated utilizing GammaPod.
3 secondary outcomes
Number of Participants With Acute Toxicities Measured by Common Terminology Criteria for Adverse Events (CTCAE); The Evaluation of Acute Toxicity During and up to 1 Month After Gamma Pod TB Boost.
Time frame: 2 months
Number of Participants With Long-term Toxicities Measured by Common Terminology Criteria for Adverse Events (CTCAE); The Evaluation of Long-term Toxicity at One Year to Assess the Presence of Subcutaneous Fibrosis and Fat Necrosis.
Time frame: 1 year
Efficacy of Medical Adhesive; Number of Participants With Adverse Events From the Use of the Adhesive Spray
Time frame: 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elizabeth M Nichols, MD principal investigator
University of Maryland, Baltimore
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Gamma Pod and CT simulation in people with Breast Cancer, run by University of Maryland, Baltimore at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Jan 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Demonstration of the Feasibility and Safety of Delivering a Radiation Treatment Using the GammaPod (TM) (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2022.