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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Cosmetic Techniques
Secondary outcome measures
Disease Specific Survival
Distant Disease-Free Interval
Cosmetic Techniques
+5 moreOther outcome measures
Health-Related Quality of Life Using EQ-5D
Quality of Life Using BREAST-Q
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.
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Who is running the clinical trial?
University of Texas Southwestern Medical CenterLead Sponsor
1,047 Previous Clinical Trials
1,053,725 Total Patients Enrolled
21 Trials studying Breast Cancer
6,188 Patients Enrolled for Breast Cancer
Asal Rahimi, MDPrincipal Investigator - UT Southwestern Medical Center
University of Texas Southwestern Medical Center
7 Previous Clinical Trials
5,234 Total Patients Enrolled
3 Trials studying Breast Cancer
99 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.My lumpectomy cavity is not within the area that can be treated by the GammaPod.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.I am a man.My breast cancer is at an advanced stage (larger than 3 cm, has spread to lymph nodes, or beyond).Your breast size is too big for the device used to hold them in place during the study.I do not have any serious illnesses or conditions that would stop me from following the study's requirements.I am a transplant recipient or I am on immunosuppressive therapy.My breast cancer is located in just one area.I have had a procedure to check for cancer spread in my underarm lymph nodes.I had a lumpectomy with clear margins for my breast cancer.My cancer has spread to nearby lymph vessels or blood vessels, but only slightly.I have an active collagen vascular disease.I agree to use birth control if I can become pregnant.I am 18 years old or older.My breast cancer is not the common type but rather a rare form like sarcoma or lymphoma.My cancer is in the early stages and has not spread to my lymph nodes.My treatment plan includes radiation therapy to the breast or nearby lymph nodes on the same side.I have Paget's disease of the nipple.
Research Study Groups:
This trial has the following groups:- Group 1: Prescription Isodose Surface Coverage
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What outcomes is this research attempting to ascertain?
"This trial will assess the Health-Related Quality of Life (HRQOL) Analysis over a 3 Year period, with secondary outcomes being Distant Disease-Free Interval, Recurrence Free Survival and Disease Specific Survival. The latter is marked by failure events such as death certified due to breast cancer, non-breast cancer related deaths with active malignancy or treatment complications irrespective of the status of malignancy. Deaths from other causes but previously documented relapse not considered in disease-specific survival are analysed separately."
Answered by AI
Are there any open slots in this research endeavor to which potential participants can apply?
"According to information located on clinicaltrials.gov, this medical trial is not currently accepting applicants. This study was originally posted on April 22nd 2019 and last updated September 7th 2022; however, there are 2602 other active trials searching for patients presently."
Answered by AI
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