Breast Cancer FemaleGCC 1876NCT03562273
GammaPod Registry and Quality of Life Nomogram
An observational study of Breast Cancer Female, run by University of Maryland, Baltimore at 4 sites in United States.
Trial summary
This study is a prospective, single arm study (registry) summarizing patient-level adverse-event and tumor outcomes as well as a number of feasibility and dosimetric characteristics of delivering a single-fraction boost with the GammaPod. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer Female
- What is being tested?
- Quality Of Life Sizing Nomogram
- Type of treatment
- Surgery or procedure
- How many people
- 160 participants
- Where
- 4 sitesUnited States
- Study dates
- 3 Jan 2019to Dec 2030
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women with breast cancer
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.
- Surgical margins are negative for invasive (no tumor on ink) or non-invasive breast cancer (2 mm negative margin).
- The greatest dimension of the tumor is less than 4cm before surgery.
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- Multifocal disease is allowed if it was removed by a single lumpectomy resection and the patient remained a candidate for breast conservation.
- Age 18 years and older.
- Women of childbearing potential (pre-menopausal defined as having a menstrual period within the past 1 year) must have a negative serum pregnancy test or complete a pregnancy waiver form per institutional policy.
- The surgical cavity is clearly visible on CT images. Of note, clips are not required but recommended.
- The patient must weigh less than 150Kg (330lb), which is the limit of the imaging couch.
- The patient must be less than 6'6" in height.
- The patient must feel comfortable in the prone position.
- Diagnosis of prior contralateral breast cancer is allowed.
- Diagnosis of synchronous bilateral cancers is allowed. In this case if bilateral boosts are required, a patient would not have both treatments on the same day.
- Oncoplastic reduction surgery is allowed if the lumpectomy cavity can be clearly visualized.
Who cannot join
- Patients with proven multi-centric carcinoma (tumors in different quadrants of the breast or tumor separated by at least 4 cm).
- Prior radiation therapy to that breast or that hemi thorax.
- 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.
- Tumor bed is less than 3 mm from the skin surface.
- Greater than 50% of the target volume is above the upper border of the table.
- 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.
- Patients with breast implants/tissue expanders or flap reconstruction.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 4 recruiting
- Recruiting
Upper Chesapeake Health
Bel Air, Maryland, 21014
Linda Romar, BS, 443-643-1877, lromar@umm.edu
Jack Hong, MD
- Recruiting
Central Maryland Oncology Center
Columbia, Maryland, 21044
Madiha Qutab, M.S., 443-328-6472, madiha.qutab@umm.edu
Sally Cheston, MD
- Recruiting
UTSouthwestern
Dallas, Texas, 75390
Sara Gamal, 214-645-8519, Sara.Gamal@UTSouthwestern.edu
Asal Rahimi, MD, MS
- Recruiting
Baltimore Washington Medical Center
Glen Burnie, Maryland, 21061
Pilar Strycula, RN, BSN, 410-553-8110, Pstrycula@.umm.edu
Wendla Citron, MD
About this study
Official title: Tumor Bed Boost Using a Breast Specific Radiosurgery Device, The GammaPodTM: Registry Study and Evaluation of Quality of Life With Development of Sizing Nomogram
This study is a prospective, single arm study (registry) summarizing patient-level adverse-event and tumor outcomes as well as a number of feasibility and dosimetric characteristics of delivering a single-fraction boost with the GammaPod.
Read the detailed description
Breast conserving therapy (BCT), consisting of surgical lumpectomy followed by whole breast radiation therapy has become the standard of care for treating early-stage breast cancers. In comparison with mastectomy, BCT demonstrated similar outcomes with superior cosmesis and reduced psychological and emotional trauma based on multiple randomized trials. At the time of the lumpectomy, the surgeon removes the tumor and a surrounding rim of normal tissue (margin), typically leaving surgical clips to help designate the resection cavity or tumor bed (TB) for the radiation oncologist. The current standard of radiation therapy for breast cancer is to deliver treatment to the whole breast to 45-50.4Gy in 25 to 28 treatments Monday through Friday. Following whole breast radiation, a 'boost' is delivered to the TB in order to deliver 60 - 66Gy to the tumor bed. Two prospective trials have demonstrated a statistically significant reduction in local failures with the addition of a boost of 10Gy(in 4 fractions @ 2.5 Gy per fraction) or 16 Gy in 8 fractions @ 2 Gy per fraction), respectively.
Boost treatments can be delivered through a variety of techniques including a single electron field (used for superficial tumor beds) or multiple photon fields (2 or 3 fields typically) for tumors that are deep to the skin (usually > 3 cm). With the use of CT simulation to guide the delivery of the boost, the need for deep TB coverage has become more apparent and now most patients receive photons for the boost portion of their therapy because the use of electrons often misses part of the tumor bed. However, when photon beams are used, in comparison to electrons, more generous margins posterior to the surgical cavity are required to account for daily set up error and respiratory motion which is not necessary for a single en face electron field. Furthermore, there are only limited directions along which the radiation can be directed to the TB, and as a result, large volumes of normal breast tissue receive a substantial fraction of the prescription dose which can lead to internal scarring (fibrosis) and poor cosmesis. The largest clinical series evaluating this issue demonstrated increased fibrosis and worse cosmetic outcome using photons. The clinical target volume for the boost is the TB, while an additional 1-1.5 cm margin of normal breast tissue is added isocentrically to account for daily set-up error and respiratory motion to define a planning target volume. Typically the boost is delivered after the whole breast portion of treatment, however, in various cases this sequence can be changed. For example, if significant skin breakdown occurs during the whole breast radiation phase, investigators can stop the whole breast radiation therapy and change to deliver dose only to the TB while allowing time for the rest of the breast to heal. This allows a continuous course of therapy to the highest risk of subclinical disease (i.e. the tumor bed).
Hypofractionation, or delivery of greater than standard 1.8 - 2 Gy fraction sizes per day, is a method of shortening overall treatment time in early stage breast cancer. Historically, standard fraction sizes of 1.8-2.0 Gy for whole breast irradiation (WBI) were based primarily on studies examining squamous cell cancers from cervix and head and neck regions. The smaller fraction sizes exploited a biological differential in squamous cell cancer fractionation sensitivity versus normal tissue fractionation sensitivity. This allowed relative sparing of surrounding normal tissue from low dose per fraction. However, investigators from the United Kingdom hypothesized that the fractionation sensitivity for adenocarcinoma of the breast is close to that of the normal breast tissue. Therefore, with increasing fraction size a sufficiently large reduction of total dose could be implemented to keep late toxicity constant without reducing the probability of tumor control.
- Conditions
- Breast Cancer Female
- Being tested
- Quality Of Life Sizing Nomogram
- Keywords
- Breast Nomogram, Breast Cancer Quality of Life, GammaPod Registry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quality Of Life Sizing NomogramRadiation
Also called GammaPod Quality Of Life Sizing Nomogram
If the participant meets the eligibility criteria of the study, and participant chooses to take part, they will receive the tumor bed boost in 8 Gy in 1 fraction just prior to starting whole breast radiation after joining the study. Treatment to the whole breast will begin within 7-8 days from the TB boost (GammaPodTM) treatment.
The radiation therapy will take approximately 6 weeks to complete. Follow-up visits specifically for this study will continue for one year, although the physician will continue to follow as part of routine care.
| Study group | Role | What they receive |
|---|---|---|
| GammaPod Quality of Life Evaluations | This study is a prospective, single arm study (registry) summarizing patient-level adverse-event and tumor outcomes as well as a number of feasibility and dosimetric characteristics of delivering a single-fraction boost with the GammaPod. Receives: Radiation: Quality Of Life Sizing Nomogram |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality Of Life Evaluations
Evaluate the quality of life impact shortening treatment by 3-4 fractions may have on a patient via questionnaire(s).
Measured: 1 year
Secondary outcomes (3)
GammaPod Nomogram construction
Development of a sizing nomogram for the breast immobilization device using a diagram representing the relations between three or more variable quantities by means of a number of scales, so arranged that the value of one variable can be found by a simple geometric construction, for example, by drawing a straight line intersecting the other scales at the appropriate values.
Measured: 1 year
Number of participants with treatment related adverse events as assessed by CTCAE v4.0
Evaluate acute toxicity of the GammaPod treatment during and up to 1 month following completion of the whole breast +/- LN portion of treatment using a questionnaire.
Measured: ~10 weeks
Number of participants with treatment related adverse events as assessed by CTCAE v4.0 post one year from treatment
The evaluation of long-term toxicity at one year to assess the presence of subcutaneous fibrosis, and fat necrosis.
Measured: ~1.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2018
- Study start3 Jan 2019
- Primary completionDec 2028 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer FemaleStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 160 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Collaborators
- University of Texas, Southwestern Medical Center at Dallas
- Responsible party
- Principal investigator, Department of Radiation Oncology, University of Maryland, Baltimore
- Investigators
- Elizabeth M. Nichols, M.D., Principal investigator, University of Maryland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03562273
- Sponsor's protocol ID
- HP-00080885
- Acronym
- GCC 1876
- Status last verified
- Feb 2026
- First submitted
- 25 May 2018
- Last updated
- 20 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tumor Bed Boost Using a Breast Specific Radiosurgery Device, The GammaPodTM: Registry Study and Evaluation of Quality of Life With Development of Sizing Nomogram
- ClinicalTrials.gov ID
- NCT03562273
- Acronym / sponsor ID
- GCC 1876 / HP-00080885
- Conditions
- Breast Cancer Female
- Keywords
- Breast Nomogram, Breast Cancer Quality of Life, GammaPod Registry
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Collaborators
- University of Texas, Southwestern Medical Center at Dallas
- Study start
- 3 Jan 2019 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 19 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a prospective, single arm study (registry) summarizing patient-level adverse-event and tumor outcomes as well as a number of feasibility and dosimetric characteristics of delivering a single-fraction boost with the GammaPod.
Detailed description
Breast conserving therapy (BCT), consisting of surgical lumpectomy followed by whole breast radiation therapy has become the standard of care for treating early-stage breast cancers. In comparison with mastectomy, BCT demonstrated similar outcomes with superior cosmesis and reduced psychological and emotional trauma based on multiple randomized trials. At the time of the lumpectomy, the surgeon removes the tumor and a surrounding rim of normal tissue (margin), typically leaving surgical clips to help designate the resection cavity or tumor bed (TB) for the radiation oncologist. The current standard of radiation therapy for breast cancer is to deliver treatment to the whole breast to 45-50.4Gy in 25 to 28 treatments Monday through Friday. Following whole breast radiation, a 'boost' is delivered to the TB in order to deliver 60 - 66Gy to the tumor bed. Two prospective trials have demonstrated a statistically significant reduction in local failures with the addition of a boost of 10Gy(in 4 fractions @ 2.5 Gy per fraction) or 16 Gy in 8 fractions @ 2 Gy per fraction), respectively.
Boost treatments can be delivered through a variety of techniques including a single electron field (used for superficial tumor beds) or multiple photon fields (2 or 3 fields typically) for tumors that are deep to the skin (usually > 3 cm). With the use of CT simulation to guide the delivery of the boost, the need for deep TB coverage has become more apparent and now most patients receive photons for the boost portion of their therapy because the use of electrons often misses part of the tumor bed. However, when photon beams are used, in comparison to electrons, more generous margins posterior to the surgical cavity are required to account for daily set up error and respiratory motion which is not necessary for a single en face electron field. Furthermore, there are only limited directions along which the radiation can be directed to the TB, and as a result, large volumes of normal breast tissue receive a substantial fraction of the prescription dose which can lead to internal scarring (fibrosis) and poor cosmesis. The largest clinical series evaluating this issue demonstrated increased fibrosis and worse cosmetic outcome using photons. The clinical target volume for the boost is the TB, while an additional 1-1.5 cm margin of normal breast tissue is added isocentrically to account for daily set-up error and respiratory motion to define a planning target volume. Typically the boost is delivered after the whole breast portion of treatment, however, in various cases this sequence can be changed. For example, if significant skin breakdown occurs during the whole breast radiation phase, investigators can stop the whole breast radiation therapy and change to deliver dose only to the TB while allowing time for the rest of the breast to heal. This allows a continuous course of therapy to the highest risk of subclinical disease (i.e. the tumor bed).
Hypofractionation, or delivery of greater than standard 1.8 - 2 Gy fraction sizes per day, is a method of shortening overall treatment time in early stage breast cancer. Historically, standard fraction sizes of 1.8-2.0 Gy for whole breast irradiation (WBI) were based primarily on studies examining squamous cell cancers from cervix and head and neck regions. The smaller fraction sizes exploited a biological differential in squamous cell cancer fractionation sensitivity versus normal tissue fractionation sensitivity. This allowed relative sparing of surrounding normal tissue from low dose per fraction. However, investigators from the United Kingdom hypothesized that the fractionation sensitivity for adenocarcinoma of the breast is close to that of the normal breast tissue. Therefore, with increasing fraction size a sufficiently large reduction of total dose could be implemented to keep late toxicity constant without reducing the probability of tumor control.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GammaPod Quality of Life Evaluations | – | Radiation: Quality Of Life Sizing NomogramThis study is a prospective, single arm study (registry) summarizing patient-level adverse-event and tumor outcomes as well as a number of feasibility and dosimetric characteristics of delivering a single-fraction boost with the GammaPod. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women with breast cancer
Key inclusion criteria (16 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.
- Surgical margins are negative for invasive (no tumor on ink) or non-invasive breast cancer (2 mm negative margin).
Key exclusion criteria (15 listed)
- Patients with proven multi-centric carcinoma (tumors in different quadrants of the breast or tumor separated by at least 4 cm).
- Prior radiation therapy to that breast or that hemi thorax.
- 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 |
|---|---|---|
| Quality Of Life Sizing NomogramAlso: GammaPod Quality Of Life Sizing NomogramIf the participant meets the eligibility criteria of the study, and participant chooses to take part, they will receive the tumor bed boost in 8 Gy in 1 fraction just prior to starting whole breast radiation after joining the study. Treatment to the whole breast will begin within 7-8 days from the TB boost (GammaPodTM) treatment. The radiation therapy will take approximately 6 weeks to complete. Follow-up visits specifically for this study will continue for one year, although the physician will continue to follow as part of routine care. | Radiation | GammaPod Quality of Life Evaluations |
Primary outcome
Quality Of Life Evaluations
Time frame: 1 year
Evaluate the quality of life impact shortening treatment by 3-4 fractions may have on a patient via questionnaire(s).
3 secondary outcomes
GammaPod Nomogram construction
Time frame: 1 year
Number of participants with treatment related adverse events as assessed by CTCAE v4.0
Time frame: ~10 weeks
Number of participants with treatment related adverse events as assessed by CTCAE v4.0 post one year from treatment
Time frame: ~1.5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2026.
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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.
Elizabeth M. Nichols, M.D. principal investigator
University of Maryland
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer Female, 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 16 inclusion and 15 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: looking for participants now, as of the sponsor's last update on 20 Feb 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elizabeth M. Nichols, M.D. (410-328-2324, enichols1@umm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality Of Life Evaluations (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 20 Feb 2026.