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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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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.

Elizabeth M. Nichols, M.D. contact

410-328-2324

enichols1@umm.edu

Madiha Qutab, M.S. contact

410-328-6472

madiha.qutab@umm.edu

United States4 sites, 4 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

    Recruiting

Other trials in United States

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.

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 groups in NCT03562273
Study groupRoleWhat they receive
GammaPod Quality of Life EvaluationsThis 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.

  1. 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)
  1. 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

  2. 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

  3. 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.

  1. First posted19 Jun 2018
  2. Study start3 Jan 2019
  3. Primary completionDec 2028 (estimated)
  4. Study completionDec 2030 (estimated)

Resources

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
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

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.

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