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IORT with Xoft Axxent System for Breast Cancer
Study Summary
This trial will compare the rate of ipsilateral breast tumor recurrence in subjects treated with a single fraction of intra-operative radiation therapy using the Xoft Axxent Electronic Brachytherapy System to those treated with whole breast irradiation at 5 years of follow-up.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- I cannot undergo radiation therapy due to health risks.My cancer has spread to my lymph or blood vessels.I have a BRCA 1 or 2 mutation.I am at high risk for breast-saving surgery or radiation during surgery.I agree to use effective birth control during and after my treatment.My breast cancer has multiple tumors larger than 3 cm in total.I have breast cancer in more than one location in the same breast.My breast cancer has come back in the same breast.My breast cancer is one of the specified types, such as adenoid cystic or mucinous.I am a woman aged 40 or older.Both of my breast cancers meet all required conditions for the trial.I have been diagnosed with a type of breast cancer that started in the milk ducts.My cancer is in the early stages and has not spread beyond its original site.My affected breast has been exposed to radiation before.I have received chemotherapy or hormone therapy before surgery for my current breast cancer.I have a pacemaker near where my breast cancer is located.I have invasive lobular cancer.My tumor is smaller than 3.0 cm in size.
- Group 1: XOFT-Intra-Operative Radiation Therapy
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
Is recruitment currently open for this investigation?
"As seen on clinicaltrials.gov, this trial is currently accepting applications from eligible patients. The listing was originally published on November 1st 2019 and has since been modified as of August 30th 2021."
Is geriatric participation being accepted in this experiment?
"According to the stated prerequisites for this research, prospective patients must have attained a minimum age of 40 and not exceed 100."
How many individuals are participating in this experiment?
"Affirmative. Clinicaltrials.gov indicates that this study, which was first published on November 11th 2019 and last revised August 30th 2021 is actively enrolling participants. The trial seeks to recruit a total of 50 patients from one clinical centre."
Is participation in this experiment an option for me?
"This clinical trial is targeting 50 individuals between 40 and 100 years of age that have been diagnosed with breast cancer."
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