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Radiation

Fractionated Radiation Therapy for Breast Cancer

N/A

Waitlist Available

Led By Asal Rahimi, MD

Research Sponsored by University of Texas Southwestern Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Women with DCIS or invasive ductal, medullary, papillary, mucinous (colloid), lobular, or tubular histologies

ECOG Performance status 0-2

Must not have

Evidence by physical examination or mammography of other suspicious masses, densities, or microcalcifications in either breast, unless biopsied and found to be benign

Previous thoracic or breast radiation on ipsilateral side

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is to study the effectiveness of SRT for treating patients with locally advanced unresectable pancreatic cancer.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects aren't listed here, stereotactic radiation can generally cause skin irritation at the treatment site, fatigue, swelling in the treated breast (edema), and sometimes pain or discomfort.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have a specific type of breast cancer.

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

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My breast cancer is located in just one area.

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I have had a procedure to check for cancer spread in my underarm lymph nodes.

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I had a lumpectomy with clear margins for my breast cancer.

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I am 18 years old or older.

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My cancer is in the early stages and has not spread to my lymph nodes.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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

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I am a man.

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My breast cancer is at an advanced stage (larger than 3 cm, has spread to lymph nodes, or beyond).

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I do not have any serious illnesses or conditions that would stop me from following the study's requirements.

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I am a transplant recipient or I am on immunosuppressive therapy.

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I have an active collagen vascular disease.

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My breast cancer is not the common type but rather a rare form like sarcoma or lymphoma.

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My treatment plan includes radiation therapy to the breast or nearby lymph nodes on the same side.

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I have Paget's disease of the nipple.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Cosmetic Techniques

Secondary study objectives

Disease Specific Survival

Distant Disease-Free Interval

Cosmetic Techniques

+5 more

Other study objectives

Health-Related Quality of Life Using EQ-5D

Quality of Life Using BREAST-Q

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Prescription Isodose Surface CoverageExperimental Treatment1 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.

0 / 17Eligibility criteria met