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Radiation Therapy
Radiation Therapy Duration for Breast Cancer
N/A
Waitlist Available
Research Sponsored by Dana-Farber Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age ≥18
Diagnosed with clinical or pathologic stage I-III invasive breast cancer with TX-T3 tumor
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10 years
Awards & highlights
Study Summary
This trial is testing a shorter course of radiation therapy vs. the conventional length for women who have had a mastectomy and immediate breast reconstruction.
Who is the study for?
This trial is for women aged 18 or older who have stage I-III invasive breast cancer, have had a mastectomy and immediate reconstruction with an expander or implant. They should be candidates for unilateral post-mastectomy radiation therapy according to NCCN guidelines. Women with T4 tumors, recurrent breast cancer, prior breast radiation, pregnancy/nursing, uncontrolled illnesses, or certain other cancers are excluded.Check my eligibility
What is being tested?
The study compares short-course (hypofractionated) radiation therapy versus conventional radiation in terms of cosmetic results after reconstructive surgery following mastectomy, lymphedema incidence, cancer control and side effects. It's randomized so patients don't choose which treatment they get.See study design
What are the potential side effects?
Radiation therapy can cause skin changes like redness and irritation at the treated site, fatigue during treatment periods that may continue afterwards, potential swelling in the arm (lymphedema), and rarely more serious complications affecting heart or lung function.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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My breast cancer is in an early to mid-stage (I-III) and has not spread beyond nearby tissues.
Select...
I had reconstructive surgery with an implant or expander right after mastectomy.
Select...
I have undergone a mastectomy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 10 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Patient reported outcomes using the FACT-B
Secondary outcome measures
Cosmetic outcomes assessed using photographic evaluations.
Oncologic and clinical outcomes assessed using medical record abstractions.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm 1: HypofractionationExperimental Treatment1 Intervention
16 fractions of radiation therapy (daily, Monday through Friday) to the chest wall with or without internal mammary nodes, and 15 fractions to the supraclavicular (with or without axillary) lymph nodes.
Group II: Arm 2: Conventional Radiation TherapyActive Control1 Intervention
25 fractions of radiation therapy (daily, Monday through Friday) to the chest wall with or without internal mammary nodes, and 23-25 fractions to the supraclavicular (with or without axillary) lymph nodes.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Radiation Therapy
2017
Completed Phase 3
~7250
Find a Location
Who is running the clinical trial?
Dana-Farber Cancer InstituteLead Sponsor
1,078 Previous Clinical Trials
340,472 Total Patients Enrolled
141 Trials studying Breast Cancer
22,217 Patients Enrolled for Breast Cancer
Patient-Centered Outcomes Research InstituteOTHER
549 Previous Clinical Trials
29,996,376 Total Patients Enrolled
7 Trials studying Breast Cancer
1,498,393 Patients Enrolled for Breast Cancer
Julia Wong, MDStudy ChairDana-Farber Cancer Institute
2 Previous Clinical Trials
190 Total Patients Enrolled
1 Trials studying Breast Cancer
32 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.My cancer is at stage T4.I do not have any severe illnesses that would stop me from joining the study.I had cancer before, but it's been 5 years and it's not likely to come back, or it was a minor skin or cervical cancer.I am eligible for radiation therapy after breast removal surgery according to NCCN guidelines.My breast cancer has come back or I've had radiation therapy for it before.My breast cancer is in an early to mid-stage (I-III) and has not spread beyond nearby tissues.I had reconstructive surgery with an implant or expander right after mastectomy.I can choose to use bolus treatment.I have undergone a mastectomy.
Research Study Groups:
This trial has the following groups:- Group 1: Arm 1: Hypofractionation
- Group 2: Arm 2: Conventional Radiation Therapy
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 there any opportunities for participants to join this medical experiment?
"This clinical trial is not presently enrolling patients, having been initially posted on April 1 2018 and last updated January 3 2022. However, there are more than 2600 other medical studies actively recruiting candidates at this moment in time."
Answered by AI
How many medical facilities are presently conducting this clinical experiment?
"At the moment, 15 medical centres are offering this clinical trial. A few notable sites include Beth Israel Deaconess Medical Center in Boston, Massachusetts General Hospital/North Shore Center for Outpatient Care in Danvers and Stanford University Medical Center situated at Stanford."
Answered by AI
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