NCT03536897 · Mount Carmel Health System
IORT Following Breast Conserving Surgery for Early Stage Breast Cancer Registry
What this study is about
This is a forward-looking, registry trial which will enroll women aged 65 and above with early stage, low risk breast cancer who will be treated with partial mastectomy and intraoperative radiation therapy (IORT). The primary aim is to determine the 5-year risk of in-breast tumor recurrence.
View original scientific description
This is a prospective, registry trial which will enroll women aged 65 and above with early stage, low risk breast cancer who will be treated with partial mastectomy and intraoperative radiation therapy (IORT). The primary aim is to determine the 5-year risk of in-breast tumor recurrence. Secondary aims include identification of acute- and late-toxicity, cosmetic result, disease-free survival and overall survival.
Interventions
RADIATION
IORT
Intraoperative radiation therapy with INTRABEAM system to a dose of 20 Gy
Primary outcome measures
In-Breast Tumor Recurrence (IBTR)
Time frame: 5 years
Ipsilateral In-Breast Tumor Recurrence (IBTR): defined as biopsy-proved invasive or in situ breast cancer (except LCIS) in the ipsilateral breast.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- ECOG performance status 0-1
- Age 65 years or older
- cT1 or cT2 (≤3.0 cm)
- Invasive ductal carcinoma histology
- Estrogen receptor positive (ER+)
- Grade 1 or Grade 2
- Clinically negative lymph nodes (cN0) by examination, imaging and/or nodal sampling
- Suitable for breast conserving surgery and radiation therapy
- Patient must be able to provide study-specific informed consent
Exclusion criteria
- Multi-centric cancer not amenable to single lumpectomy
- Prior ipsilateral whole breast radiation
- Known BRCA 1 or BRCA 2 mutation
- Status post neoadjuvant hormonal or chemotherapy
- Invasive lobular histology
- Pure ductal carcinoma in situ (DCIS)
- Diffuse suspicious microcalcifications
Where
- Columbus, Ohio
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Nov 27, 2024 · Source of record for eligibility and locations