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Radiation Therapy
Intraoperative Radiotherapy for Breast Cancer
N/A
Recruiting
Led By Eileen Connolly, MD
Research Sponsored by Columbia University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Plans to administer irradiation to the breast only
Women of child-bearing potential must agree to use adequate contraceptive precautions (defined as oral contraceptives, intrauterine devices, surgical contraceptives, or combination of condom and spermicide) from the time of negative pregnancy test through the radiation treatment period
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
Study Summary
This trial will look at using Intraoperative Radiotherapy (IORT) to treat Ductal Carcinoma In-Situ (DCIS). Researchers want to learn more about how well it works and what effects it has on patients.
Who is the study for?
This trial is for women with a specific breast condition called DCIS, who are fit enough for surgery and radiation (ECOG 0-3), have no invasive cancer or multiple tumors in one breast, no lymph node involvement, and not pregnant. They must be able to follow up for 5 years and use birth control if of childbearing age.Check my eligibility
What is being tested?
The study tests Intraoperative Radiotherapy (IORT) as a treatment option for Ductal Carcinoma In-Situ (DCIS) of the breast. It aims to understand its effects on clinical outcomes, imaging results, and patient quality of life through questionnaires.See study design
What are the potential side effects?
While the trial focuses on IORT's effectiveness and impact rather than side effects, typical risks may include skin irritation, fatigue, pain or discomfort at the treatment site. Quality of Life Questionnaires assess personal experiences.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am scheduled for radiation therapy to my breast only.
Select...
I agree to use effective birth control during the study.
Select...
My breast cancer is diagnosed as DCIS.
Select...
My breast cancer is at an early stage and can be removed with surgery.
Select...
My cancer is in one spot and is 3 cm or smaller.
Select...
My cancer 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
Rate of local recurrence
Secondary outcome measures
Acute Coryza
Disease
Longterm radiation toxicity
+1 moreSide effects data
From 2008 Phase 4 trial • 314 Patients • NCT007340975%
Headache
100%
80%
60%
40%
20%
0%
Study treatment Arm
Esomeprazole 40mg, Daily
Trial Design
2Treatment groups
Experimental Treatment
Group I: Low/Intermediate Grade DCISExperimental Treatment1 Intervention
Subjects with Low/Intermediate Grade DCIS will complete quality of life questionnaires before and after the IORT.
Group II: High Grade DCISExperimental Treatment1 Intervention
Subjects with High Grade DCIS will complete quality of life questionnaires before and after the IORT.
Find a Location
Who is running the clinical trial?
Columbia UniversityLead Sponsor
1,433 Previous Clinical Trials
2,446,994 Total Patients Enrolled
Eileen Connolly, MDPrincipal Investigator - Assistant Professor of Radiation Oncology
Columbia Presbyterian Radiologists, New York Presbyterian Hospital-Columbia Presbyterian Center
New York University School Of Medicine (Medical School)
2 Previous Clinical Trials
45 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I speak English or Spanish.I am scheduled for radiation therapy to my breast only.I can care for myself but may not be able to do active work.I am a woman who can have children and have a negative pregnancy test.I agree to use effective birth control during the study.I have been diagnosed with invasive breast cancer.My cancer is in one spot and is 3 cm or smaller.I have multiple tumors in one breast that cannot be removed with a single surgery.I was diagnosed with cancer in both breasts at the same time.My breast cancer is diagnosed as DCIS.My breast cancer is at an early stage and can be removed with surgery.I do not have any severe illness that would limit my life to under 5 years.I do not have any severe illnesses or social situations that would stop me from following the study's requirements.My cancer has spread to my lymph nodes.I have had breast cancer or radiation in the same breast before.My cancer has not spread to my lymph nodes.
Research Study Groups:
This trial has the following groups:- Group 1: High Grade DCIS
- Group 2: Low/Intermediate Grade DCIS
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 is the cap on enrolment for this clinical experiment?
"Affirmative. Per the information found on clinicaltrials.gov, this experiment is presently recruiting participants and was first listed in September 2017 before being edited for the latest time in October 2022. 265 test subjects are required between two locations."
Answered by AI
Are there any vacancies still accessible to participants in this clinical trial?
"Absolutely, the clinicaltrials.gov entry states that this trial is currently enrolling patients. This experiment was initially listed on September 12th 2017 and updated most recently on October 10th 2022. 265 individuals are needed to partake in this research from 2 different sites."
Answered by AI
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