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Radiation Therapy
Accelerated Partial Breast Irradiation for Breast Cancer
N/A
Waitlist Available
Led By Frederick M. Dirbas
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Tumor < 2.5 cm in size, 2 mm margin of normal breast tissue between cancer and edge of specimen.
Women >= 40 with invasive ductal carcinoma or ductal carcinoma in situ
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 20 years
Awards & highlights
Study Summary
This trial is testing different courses of radiation therapy to see which is most effective and safe for treating breast cancer.
Who is the study for?
This trial is for women aged 40 or older with invasive ductal carcinoma or ductal carcinoma in situ, choosing lumpectomy over mastectomy. The tumor must be smaller than 2.5 cm with a clear margin of normal tissue around it. It's not for those who are immunocompromised, pregnant, have poorly controlled diabetes, previous malignancies with less than five years survival expectation, certain breast implants, or contraindications to radiotherapy.Check my eligibility
What is being tested?
The study tests if accelerated radiotherapy after lumpectomy is as safe and effective as the standard six-week course. Methods include IORT as a single dose; intracavitary brachytherapy over five days; partial breast 3-D CRT in five days; or stereotactic APBI across four days. Outcomes like treatment complications, cosmetic results, cancer recurrence rates and overall survival will be measured.See study design
What are the potential side effects?
Potential side effects may include skin changes at the treatment site such as redness and irritation, fatigue due to radiation exposure, discomfort from the procedure itself and rare risks associated with radiation such as secondary cancers.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My tumor is smaller than 2.5 cm with a clear margin of normal tissue around it.
Select...
I am a woman over 40 with a type of breast cancer.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 20 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~20 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
In-breast tumor recurrence (IBTR)
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Accelerated Partial Breast IrradiationExperimental Treatment5 Interventions
lumpectomy with accelerated partial breast irradiation
Group II: Standard TherapyActive Control2 Interventions
lumpectomy and whole breast irradiation
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lumpectomy
2008
N/A
~670
Find a Location
Who is running the clinical trial?
Stanford UniversityLead Sponsor
2,386 Previous Clinical Trials
17,333,608 Total Patients Enrolled
60 Trials studying Breast Cancer
110,780 Patients Enrolled for Breast Cancer
Frederick M. DirbasPrincipal InvestigatorStanford University
1 Previous Clinical Trials
1 Trials studying Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer was found in lymph nodes during my lumpectomy.It has been over 12 weeks since my last surgery or chemotherapy.I have breast implants placed before any cancer treatment.I have chosen lumpectomy over mastectomy for my breast cancer treatment.My immune system is weak.My breast cancer is of the invasive lobular type.I am a man.I have had cancer before, but it was not spreading or expected to shorten my life by more than 5 years.My diabetes, which requires insulin, is not well-controlled.I cannot receive radiotherapy due to a condition like scleroderma.My breast cancer is present in more than one location.My tumor is smaller than 2.5 cm with a clear margin of normal tissue around it.I have 1 to 3 lymph nodes with cancer found after surgery.My breast cancer has spread to my skin or chest wall.My breast cancer has a large area of growth within the milk ducts.I am a woman over 40 with a type of breast cancer.
Research Study Groups:
This trial has the following groups:- Group 1: Standard Therapy
- Group 2: Accelerated Partial Breast Irradiation
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.
Are applications currently being accepted for this medical experiment?
"Clinicaltrials.gov informs us that this research endeavour, first posted on September 1st 2002 and most recently edited in February 11th 2022, is not currently registering participants. Nevertheless, there are 2,635 other studies which are presently open for enrollment."
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