GammaPod Registry and Quality of Life Nomogram (GCC 1876)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03562273|
Recruitment Status : Recruiting
First Posted : June 19, 2018
Last Update Posted : August 27, 2020
|Condition or disease||Intervention/treatment|
|Breast Cancer Female||Radiation: Quality Of Life Sizing Nomogram|
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 Type :||Observational [Patient Registry]|
|Estimated Enrollment :||160 participants|
|Target Follow-Up Duration:||1 Year|
|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|
|Actual Study Start Date :||January 3, 2019|
|Estimated Primary Completion Date :||December 2022|
|Estimated Study Completion Date :||December 2023|
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.
Radiation: 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.
Other Name: GammaPod Quality Of Life Sizing Nomogram
- 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).
- GammaPod Nomogram construction [ Time Frame: 1 year ]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.
- Number of participants with treatment related adverse events as assessed by CTCAE v4.0 [ Time Frame: ~10 weeks ]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.
- Number of participants with treatment related adverse events as assessed by CTCAE v4.0 post one year from treatment [ Time Frame: ~1.5 years ]The evaluation of long-term toxicity at one year to assess the presence of subcutaneous fibrosis, and fat necrosis.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03562273
|Contact: Elizabeth M. Nichols, M.D.||email@example.com|
|Contact: Madiha Qutab, M.S.||firstname.lastname@example.org|
|United States, Maryland|
|Upper Chesapeake Health||Recruiting|
|Bel Air, Maryland, United States, 21014|
|Contact: Linda Romar, BS 443-643-1877 email@example.com|
|Sub-Investigator: Jack Hong, MD|
|Central Maryland Oncology Center||Recruiting|
|Columbia, Maryland, United States, 21044|
|Contact: Madiha Qutab, M.S. 443-328-6472 firstname.lastname@example.org|
|Sub-Investigator: Sally Cheston, MD|
|Baltimore Washington Medical Center||Recruiting|
|Glen Burnie, Maryland, United States, 21061|
|Contact: Pilar Strycula, RN, BSN 410-553-8110 Pstrycula@.umm.edu|
|Sub-Investigator: Wendla Citron, MD|
|United States, Texas|
|Dallas, Texas, United States, 75390|
|Contact: Sara Gamal 214-645-8519 Sara.Gamal@UTSouthwestern.edu|
|Principal Investigator: Asal Rahimi, MD, MS|
|Principal Investigator:||Elizabeth M. Nichols, M.D.||University of Maryland, College Park|