Your session is about to expire
← Back to Search
Radiation Therapy
Partial Breast Irradiation with CyberKnife for Breast Cancer (CKPBI Trial)
N/A
Waitlist Available
Led By Ken Dornfeld, MD
Research Sponsored by Essentia Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Resection margins negative by at least 2mm
ER positive
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one year
Awards & highlights
CKPBI Trial Summary
This trial will test whether it is safe and effective to use Cyberknife radiotherapy to deliver partial breast radiotherapy after lumpectomy.
Who is the study for?
This trial is for individuals aged 60 or older with early-stage breast cancer, specifically unicentric invasive ductal malignancy at stage T1. Participants must have had a lumpectomy with clear margins of at least 2mm and no nodal metastases (N0). They should not have received prior radiotherapy to the breast, chemotherapy before surgery, or have multicentric disease or node-positive disease.Check my eligibility
What is being tested?
The study tests if CyberKnife stereotactic radiotherapy is a feasible and safe option for partial breast irradiation after lumpectomy. It involves ten sessions over five days. The focus will be on short-term and long-term safety as well as effectiveness in tumor control and potential failure sites.See study design
What are the potential side effects?
Potential side effects may include skin reactions, fatigue, changes in breast appearance, pain or discomfort at the treatment site, and rare risks associated with radiation such as secondary cancers.
CKPBI Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer surgery removed all visible cancer with a clear margin of at least 2mm.
Select...
My cancer is estrogen receptor positive.
Select...
My cancer has not spread to my lymph nodes.
Select...
I have had a lumpectomy.
Select...
My breast cancer is in the early stage (T1).
Select...
I am 60 years old or older.
Select...
The area treated with lumpectomy is less than 30% of my whole breast.
CKPBI Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
To determine the feasibility of using CyberKnife radiotherapy to deliver partial breast radiotherapy for early stage breast cancer.
Secondary outcome measures
To determine if conformal irradiation to the operative bed using CyberKnife produces acceptable local control
CKPBI Trial Design
1Treatment groups
Experimental Treatment
Group I: Stereotactic radiotherapyExperimental Treatment2 Interventions
Accelerated stereotactic radiotherapy as an adjuvant treatment for early stage breast cancer.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
stereotactic radiotherapy
2014
N/A
~60
Find a Location
Who is running the clinical trial?
Essentia HealthLead Sponsor
26 Previous Clinical Trials
108,190 Total Patients Enrolled
1 Trials studying Breast Cancer
20 Patients Enrolled for Breast Cancer
Ken Dornfeld, MDPrincipal InvestigatorEssentia Health Oncology
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer surgery removed all visible cancer with a clear margin of at least 2mm.The trial is only open to individuals with cancer that is located in one specific area of the body.My breast cancer has a significant intraductal component.My cancer is estrogen receptor positive.My cancer has not spread to my lymph nodes.I have had a lumpectomy.My cancer is present in multiple locations within the same organ.My cancer has spread to nearby lymph nodes.I have received chemotherapy before surgery.I have had radiation therapy to the breast before.My breast cancer is diagnosed as DCIS only.My breast cancer is in the early stage (T1).I am 60 years old or older.My breast cancer is of the invasive ductal type.The area treated with lumpectomy is less than 30% of my whole breast.My condition's severity is not limited by grade.
Research Study Groups:
This trial has the following groups:- Group 1: Stereotactic radiotherapy
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.
Is this experimentation open to the elderly demographic?
"This trial only considers patients between the ages of 60 and 65. For those younger than 18, there are 74 medical trials available for them to join, whereas older adults have access to 2508 different studies."
Answered by AI
Is recruitment still open for participants in this research project?
"According to clinicaltrials.gov, this particular study has now closed recruitment; the trial was first posted in June of 2010 with a final edit on May 28th 2022. However, there are still 2603 other medical trials actively enrolling patients at this time."
Answered by AI
Would I qualify to become a subject for this clinical experiment?
"This trial is seeking 20 breast cancer patients aged 60 and above. The essential requirements for applicants are: any grade, ER positive, unicentric invasive ductal carcinoma, lumpectomy as their primary surgical treatment, pathologically free of nodal metastases (N0 i- or i+), and a post-lumpectomy cavity to whole breast ratio no greater than 30%."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger