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Radiation Therapy
IMRT vs. APBI for Early Stage Breast Cancer (2009-APBI Trial)
Phase 3
Recruiting
Led By Charles Leonard, MD
Research Sponsored by Rocky Mountain Cancer Centers
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subjects with DCIS will be included in the study only if they had an MRI prior to lumpectomy.
Microscopic multifocal disease is only allowed when the entire span of identified disease measures 3.0 cm or less.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5-15 years
Awards & highlights
2009-APBI Trial Summary
This trial shows that a new type of radiation therapy is effective and safe for treating breast cancer. It also spare more normal breast and lung tissue.
Who is the study for?
This trial is for early stage breast cancer patients who've had a lumpectomy with clear margins and no widespread disease. They must start radiotherapy within 10 weeks post-surgery, have localized disease confirmed by MRI, and be willing to follow the study's protocol.Check my eligibility
What is being tested?
The trial compares two types of radiation therapy after lumpectomy: Intensity Modulated Radiotherapy (IMRT) versus standard 3D-conformal Accelerated Partial Breast Irradiation (APBI). It aims to see if IMRT better spares healthy tissue and improves outcomes.See study design
What are the potential side effects?
Potential side effects include skin irritation, fatigue, changes in breast size or shape, pain or discomfort at the treatment site, and rare lung inflammation due to exposure during treatment.
2009-APBI Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I had an MRI before my lumpectomy for DCIS.
Select...
My cancer is small and confined, measuring 3.0 cm or less.
Select...
My last surgery removed all the cancer with clear margins.
Select...
My cancer is early stage and has not spread beyond its original site.
Select...
I have markers placed in my body for radiation therapy that do not move.
2009-APBI Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5-15 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5-15 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Prevalence of breast pain after Accelerated Partial Breast Radiotherapy (APBI)
Prevalence of chest wall pain after Accelerated Partial Breast Radiotherapy (APBI)
Secondary outcome measures
Acute skin reactions
Cause specific survival
Cosmetic outcomes after APBI
+4 more2009-APBI Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: IMRTExperimental Treatment1 Intervention
Intensity modulated radiotherapy, 38.5 Gy, 10 fractions over 5 days
Group II: 3D-CRTActive Control1 Intervention
Three dimensional conformal external radiotherapy, 38.5 Gy, 10 fractions over 5 days
Find a Location
Who is running the clinical trial?
Rocky Mountain Cancer CentersLead Sponsor
7 Previous Clinical Trials
849 Total Patients Enrolled
1 Trials studying Breast Cancer
291 Patients Enrolled for Breast Cancer
Charles Leonard, MDPrincipal InvestigatorRocky Mountain Cancer Centers
1 Previous Clinical Trials
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I had an MRI before my lumpectomy for DCIS.I am scheduled for radiotherapy within 10 weeks after my breast surgery.I need a breast MRI to confirm my cancer is localized due to its specific type.My cancer is small and confined, measuring 3.0 cm or less.My cancer has multiple visible tumors larger than 3.0 cm.My last surgery didn’t remove all the cancer, leaving some very close to the edge of what was taken out.My last surgery removed all the cancer with clear margins.My MRI suggests cancer may be beyond the initial surgery area and needs further checks.I will need another mammogram after surgery to check if all cancer signs are gone.I have persistent cancerous or suspicious calcium deposits.The ratio of the planned treatment volume to the same side of the breast should be less than 25%.I have a collagen-vascular disease.My cancer is early stage and has not spread beyond its original site.I have markers placed in my body for radiation therapy that do not move.
Research Study Groups:
This trial has the following groups:- Group 1: IMRT
- Group 2: 3D-CRT
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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 subjects needed for this experiment currently being recruited?
"According to the latest update on clinicaltrials.gov, this trial is still looking for patients. The trial was originally posted on 7/1/2009."
Answered by AI
Does the FDA allow for the use of IMRT in APBI patients?
"There is a fair amount of clinical data supporting the safety of accelerated partial breast irradiation - IMRT planning, as this treatment is currently in Phase 3 trials."
Answered by AI
How many people suffering from this condition can be a part of this experiment?
"Yes, the trial is still open and recruiting patients. It was first posted on 7/1/2009, with the most recent update on 6/24/2014. The study needs 660 individuals from 5 different locations."
Answered by AI
If this study were to be conducted again, how many different places would be used?
"To make things more convenient for enrollees, the 5 sites for this clinical trial are all located within Aurora, Thornton and Littleton. There are also 5 other locations for the trial, so participants can choose the site that is closest to them."
Answered by AI
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