Fractionated Radiation Therapy for Breast Cancer

Not currently recruiting at 1 trial location

Overseen By Sarah Neufeld

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Texas Southwestern Medical Center

Must not be taking: Immunosuppressants

Disqualifiers: Men, Stage III/IV cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

Duration: 1 week

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore a new method of using radiation therapy to treat breast cancer. It focuses on stereotactic radiation, a technique that delivers precise radiation doses to the tumor while sparing surrounding healthy tissue. The trial will test the effectiveness of this method using a device called GammaPod. Women who have undergone a lumpectomy for certain types of early-stage breast cancer with a tumor size of 3 cm or less might be suitable candidates for this trial. As an unphased trial, it offers participants the opportunity to contribute to innovative research that could enhance future breast cancer treatments.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are on immunosuppressive therapy, you may not be eligible to participate.

What prior data suggests that this technique is safe for treating breast cancer?

Research has shown that the GammaPod system for radiation therapy is generally safe for treating breast cancer. Studies have found that a single session of GammaPod radiation is well-tolerated, with patients experiencing no more side effects than typically expected from this treatment. Another study found that patients handle GammaPod easily, without severe side effects. Early results also suggest it effectively controls cancer growth, which is promising. In summary, current research considers the GammaPod system safe, with side effects similar to other standard treatments. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using the Gammapod for breast cancer treatment because it offers a unique approach compared to standard radiation therapy. While traditional radiation treatments can require several weeks, the Gammapod uses a specialized method called fractionated radiation therapy, delivering high doses in just five sessions. This precise targeting helps protect healthy tissue and potentially reduces side effects like fat necrosis. The hope is that this method will make treatment faster and more comfortable for patients while maintaining effectiveness.

What evidence suggests that stereotactic radiation therapy is effective for breast cancer?

Research has shown that GammaPod, a special type of radiation therapy, holds promise for treating breast cancer. Studies have found that GammaPod treatment is well-tolerated and offers good early control of the disease. In one study, 82% of patients completed their GammaPod treatment successfully. Another study reported excellent results with single-session treatments, where patients receive their entire radiation dose in just one visit. These findings suggest that GammaPod could be an effective option for treating breast cancer with few side effects. ^{1 2 6 7 8}

Who Is on the Research Team?

Asal Rahimi, MD

Principal Investigator

UT Southwestern Medical Center

Are You a Good Fit for This Trial?

This trial is for women aged 18+ with certain types of breast cancer (like DCIS or invasive ductal) that's localized and hasn't spread. They must have had a lumpectomy with clear margins, be in good health overall, not pregnant or nursing, and willing to use contraception. It excludes those with large breasts for the device, prior chest radiation, advanced cancer stages, immunosuppression issues, or other serious illnesses.

Inclusion Criteria

I have a specific type of breast cancer.

I can take care of myself and am up and about more than half of the day.

My breast cancer is located in just one area.

Exclusion Criteria

I have suspicious breast findings not confirmed as benign by biopsy.

I have had radiation therapy on the same side as my current cancer.

I have had radiation or chemotherapy for my current breast cancer before GammaPod treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive stereotactic partial breast irradiation using the GammaPod over 5 fractions

1 week

5 visits (in-person)

Follow-up

Participants are monitored for safety, effectiveness, and cosmesis after treatment

3 years

Annual visits (in-person)

Long-term follow-up

Participants' quality of life and health outcomes are assessed using BREAST-Q and EQ-5D instruments

5 years

What Are the Treatments Tested in This Trial?

Interventions

• Gammapod

Trial Overview The trial tests a precise form of stereotactic partial breast irradiation called GammaPod on patients who've had surgery for early-stage breast cancer. It aims to deliver high doses of radiation accurately to the affected area while sparing healthy tissue.

How Is the Trial Designed?

Group I: Prescription Isodose Surface Coverage Experimental Treatment 1 Intervention

The dose fractionation to the CTV (1cm expansion on cavity) will be 40Gy/ 5 fractions and the PTV (3 mm expansion of CTV) will be a minimum dose of 30Gy/5 fractions. If PTV \>100cc or if dose constraints cannot be met on higher dose prescribe CTV (1.0cm) to 35Gy/5 fractions and PTV (3mm) to 30Gy/5 fractions. This is to potentially reduce risk of fat necrosis.

Who Is Running the Clinical Trial?

University of Texas Southwestern Medical Center

Lead Sponsor

Trials

1,102

Recruited

1,077,000+

Published Research Related to This Trial

GammaPod is a specialized device for stereotactic radiation therapy of breast cancer, which has been effectively used at our institution for various treatment protocols, including adjuvant partial breast irradiation and preoperative radiation.

In our experience with 93 patients treated from 2019 to 2021, we developed techniques to improve workflow efficiency, highlighting the practical application and potential benefits of GammaPod in breast cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A How-To Compendium for GammaPod Treatments, Clinical Workflow, and Clinical Program at an Early Adopting Institution. Zhang-Velten, E., Zhang, Y., Radpour, S., et al.[2022]

The GammaPod™ device, designed specifically for treating small breast cancers, demonstrated high dosimetric accuracy and spatial precision, with an isocenter location accuracy of less than 1 mm and a gamma index pass rate of over 97% in dosimetric verifications for seven patients.

This innovative stereotactic radiotherapy system delivers uniform doses with a rate of 5.31 Gy/min, utilizing dynamic dose shaping and noncoplanar beam arrangements, making it a promising option for complex breast cancer treatment plans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dosimetric and geometric evaluation of a novel stereotactic radiotherapy device for breast cancer: the GammaPod™. Mutaf, YD., Zhang, J., Yu, CX., et al.[2018]

Recent studies support the use of shorter radiotherapy courses for early-stage breast cancer, with ultra-hypofractionated regimens allowing treatment in as few as 5 sessions, which can reduce the burden on patients.

Breast cancer is increasingly recognized as a low alpha-beta ratio malignancy, suggesting that larger doses per fraction may be more effective, leading to a shift towards hypofractionated and ultra-hypofractionated treatment approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early-stage Breast Cancer: Tailored External Beam Fractionation Approaches for Treatment of the Whole or Partial Breast. Prionas, ND., Stephens, SJ., Blitzblau, RC.[2022]

In a study of 2309 breast cancer patients, those receiving hypofractionated radiotherapy experienced significantly less acute skin reactions and pain compared to those receiving conventional fractionation, indicating a safer treatment option.

Hypofractionation also resulted in lower levels of patient-reported symptoms like burning, swelling, and fatigue during treatment, suggesting it may enhance patient comfort without compromising long-term outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Differences in the Acute Toxic Effects of Breast Radiotherapy by Fractionation Schedule: Comparative Analysis of Physician-Assessed and Patient-Reported Outcomes in a Large Multicenter Cohort. Jagsi, R., Griffith, KA., Boike, TP., et al.[2022]

The GammaPodTM device, designed for stereotactic radiotherapy in early-stage breast cancer, demonstrated excellent dosimetric accuracy with a spatial precision of less than 1 mm and a high Gamma index pass rate of over 97% in dosimetric verifications for eight patients.

With a delivery rate of 5.31 Gy/min and the ability to create complex treatment plans through dynamic dose shaping, the GammaPod provides uniform doses to targets, indicating its potential efficacy in improving treatment outcomes for breast cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

SU-E-T-399: Dosimetric and Geometric Evaluation of a Novel Stereotactic Radiotherapy Device for Breast Cancer: The GammaPod. Mutaf, Y., Yu, C., Zhang, J., et al.[2019]

The study developed a reliable method to estimate treatment times for the GammaPod device used in breast cancer therapy, based on target volume, using data from 59 patient treatments.

The method demonstrated high accuracy in predicting treatment times for an additional 30 patients, with an average difference of only 1.0 minute from actual times, making it a useful tool for quality assurance in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Correlation of treatment time to target volume for GammaPod treatments: A simple second calculation. Chen, L., Becker, SJ., McAvoy, SA., et al.[2022]

In a study of 708 breast cancer patients, those receiving nodal radiation therapy with hypofractionation (HF) reported fewer arm symptoms, such as shoulder stiffness and difficulty moving the arm, compared to those receiving conventional fractionation (CF).

The findings suggest that hypofractionated nodal radiation therapy does not lead to increased arm symptoms or functional deficits, supporting its use as a shorter treatment option without compromising patient quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hypofractionated Nodal Radiation Therapy for Breast Cancer Was Not Associated With Increased Patient-Reported Arm or Brachial Plexopathy Symptoms. Leong, N., Truong, PT., Tankel, K., et al.[2018]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11110030/

A Prospective Trial of Single-Fraction Radiation to the ... A GammaPod treatment was successfully completed in 14 of the 17 patients enrolled, corresponding to a success rate of 82% with a lower 1-sided ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0360301625064004

Post-Operative Single Fraction Stereotactic Partial Breast ... Single-fraction S-PBI using GammaPod™ was associated with excellent tolerability and promising early oncologic control in early breast cancer.

3. gammapod.eu gammapod.eu/en/2023/09/26/gammapod-new-era-breast-cancer-stereotactic-radiotherapy/

Breast cancer stereotactic radiotherapy, a new era is coming Breast cancer stereotactic radiotherapy, Dr. Marco Trovò presents the results obtained in three clinical trials with GammaPod.

4. temasinergie.com temasinergie.com/estro-2023-promising-results-first-european-trial-gammapod-system-treatment-breast-cancer/

ESTRO 2023: promising results from the first European Trial ... The purpose of this study was to examine the toxicity of partial breast irradiation in a single fraction, following conservative surgery, using ...

5. mdproton.com mdproton.com/dr-elizabeth-nichols-explains-gammapod-radiation-therapy-an-important-advancement-for-early-stage-breast-cancer/

Dr. Elizabeth Nichols Explains GammaPod Radiation ... The GammaPod radiation therapy system is designed specifically around the treatment of partial breast radiation for early-stage breast cancer patients.

6. umms.org umms.org/umgccc/news/2017/stereotactic-radiation-therapy-system-designed-to-treat-early-stage-breast-cancer

First Stereotactic Radiation Therapy System Designed To ... Initial results indicate that the GammaPod system can deliver radiation to the breast safely, according to the study's principal investigator, ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT03581136

Study Details | NCT03581136 | Phase II Multi-center Trial ... As the GammaPod will allow us to minimize the volume of normal breast being irradiated, and decrease the PTV volume we hypothesize that a stereotactic technique ...

8. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2020-07926

Single Dose Preoperative Breast Stereotactic Body ... A single dose of preoperative breast stereotactic body radiation therapy using the GammaPod machine may produce fewer side effects than standard treatment and ...