Fractionated Radiation Therapy for Breast Cancer

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

74 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment GammaPod for breast cancer?

The GammaPod is a new device designed specifically for treating early-stage breast cancer with precise radiation. It uses advanced technology to deliver targeted radiation, which can help protect healthy tissue while effectively treating the cancer. ^{1 2 3 4 5}

Is fractionated radiation therapy for breast cancer safe for humans?

Research shows that hypofractionated radiation therapy, a type of fractionated radiation, is generally safe for breast cancer patients, with studies indicating no significant increase in arm symptoms or severe side effects compared to conventional methods. Safety has been confirmed in various patient groups, including those with larger breasts and different risk factors, with manageable skin toxicity and good quality of life reported. ^{6 7 8 9 10}

How is the Gammapod treatment for breast cancer different from other treatments?

The Gammapod treatment for breast cancer is unique because it uses a specialized form of radiation therapy that allows for precise targeting of the tumor, potentially reducing the treatment time and minimizing exposure to surrounding healthy tissue compared to traditional radiation therapy methods. ^{11 12 13 14 15}

What is the purpose of this trial?

Stereotactic radiation has been implemented more than 3 decades ago, initially to radiate benign and later malignant tumors within the brain. Doses up to 24 Gy in one session have been used. Hundreds of thousands of patients have been treated worldwide with very good outcomes . Over the last decade, the stereotactic radiation techniques have been implemented to treat extra-cranial tumors. The challenges of extra cranial tumors were in part target motion during the radiation session, but also accurate re positioning of the patient and of the target volume at time of radiation treatment. Specific immobilization devices are now available to improve accuracy of target localization. Stereotactic radiation therapy is widely available, non-invasive for the patient and less operator dependent as the planning process (from target volume to dose calculation) can be done and verified by different operators through a quality assessment procedure. Stereotactic radiation is a complex type of 3D CRT that is a very attractive technique making the 3D CRT more conformal and more accurate delivery of the prescription dose within the target volume with a very good sparing of surrounding normal tissue. The principles of stereotactic radiation are the following: precise image definition of target volume and OARs, very conformal radiation treatment.

Research Team

Asal Rahimi, MD

Principal Investigator

UT Southwestern Medical Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

SU-E-T-399: Dosimetric and Geometric Evaluation of a Novel Stereotactic Radiotherapy Device for Breast Cancer: The GammaPod. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Correlation of treatment time to target volume for GammaPod treatments: A simple second calculation. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

A How-To Compendium for GammaPod Treatments, Clinical Workflow, and Clinical Program at an Early Adopting Institution. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

GammaPod-a new device dedicated for stereotactic radiotherapy of breast cancer. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Dosimetric and geometric evaluation of a novel stereotactic radiotherapy device for breast cancer: the GammaPod™. [2018]

6. United States 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. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Feasibility and acute toxicity of hypofractionated radiation in large-breasted patients. [2018]

8. England pubmed.ncbi.nlm.nih.gov

A primary analysis of a multicenter, prospective, single-arm, confirmatory trial of hypofractionated whole breast irradiation after breast-conserving surgery in Japan: JCOG0906. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Hypofractionated Nodal Radiation Therapy for Breast Cancer Was Not Associated With Increased Patient-Reported Arm or Brachial Plexopathy Symptoms. [2018]

10. England pubmed.ncbi.nlm.nih.gov

Hypofractionated radiotherapy with concomitant boost for breast cancer: a dose escalation study. [2023]

11. Italy pubmed.ncbi.nlm.nih.gov

Dose fractionation and biological optimization in breast cancer. [2018]

12. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Survival and prognostic factors in radiation and combination therapy of bone metastases of breast cancer]. [2006]

13. United States pubmed.ncbi.nlm.nih.gov

T1 stage breast cancer: adjuvant hypofractionated conformal radiation therapy to tumor bed in selected postmenopausal breast cancer patients--pilot feasibility study. [2018]

14. United States pubmed.ncbi.nlm.nih.gov

Early-stage Breast Cancer: Tailored External Beam Fractionation Approaches for Treatment of the Whole or Partial Breast. [2022]

15. United States pubmed.ncbi.nlm.nih.gov

Randomized trial of breast irradiation schedules after lumpectomy for women with lymph node-negative breast cancer. [2022]