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Radiation

Shorter Course Radiation for Breast Cancer

Phase 2
Waitlist Available
Led By Christine Fisher, MD, MPH
Research Sponsored by University of Colorado, Denver
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Women less than 50 years of age, women who received chemotherapy, patients staged as pN0 (i+ or mol+), and large-breasted women are eligible for enrollment
Adult women (≥18 years old) with breast cancer who have undergone surgery for their primary breast tumor (either lumpectomy or mastectomy +/- reconstruction) and are confirmed to have involved lymph nodes on surgical pathology
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 60 months
Awards & highlights

Study Summary

This trial is testing a new, shorter radiation treatment for breast cancer patients who have had surgery to remove cancerous lymph nodes.

Who is the study for?
This trial is for adult women with breast cancer who've had surgery and found cancer in their lymph nodes. They must be under 50, may have had chemo, and should not have severe side effects from past treatments. Their last surgery or chemo should be within the past 180 days, they need to understand and agree to the study by signing a consent form.Check my eligibility
What is being tested?
The study tests a shorter radiation treatment schedule for breast cancer that has spread to lymph nodes after surgery. It aims to see if this quicker method is as effective as traditional longer courses of radiation therapy.See study design
What are the potential side effects?
While specific side effects are not listed here, typical ones from radiation may include skin irritation at the treatment site, fatigue, mild swelling in treated area, and changes in breast texture.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am a woman under 50, had chemotherapy, have a specific cancer stage, or am large-breasted.
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I am an adult woman with breast cancer, had surgery, and my lymph nodes were affected.
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My surgery will include checking the lymph nodes in my armpit.
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I am fully active or able to carry out light work.
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My breast cancer stage fits specific criteria after surgery and before any advanced treatment.
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Side effects from my previous chemotherapy that could affect radiation treatment have gone away.
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My last breast cancer surgery was less than 6 months ago, and I haven't had chemotherapy after.
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I have had either a total mastectomy or a lumpectomy.
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My last chemotherapy was within the last 6 months.
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My surgical wound has fully healed without any infection.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 60 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 60 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of participants reporting shoulder stiffness as measured by the European Organization for Research and Treatment of Cancer Quality of Life questionnaire (EORTC QLQ-C3014) and breast-cancer module (BR23)
Lymphedema
Number of participants with new development of ischemic heart disease as measured by EKG
+2 more
Secondary outcome measures
Number of participants with a change in quality of life score as measured by the EORTC QLQ-C3014 and breast-cancer module (BR23)
Number of participants with disease recurrence
Number of participants with local-regional failure free survival
+1 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Adjuvant Hypofractionated RadiationExperimental Treatment1 Intervention
Adjuvant Hypofractionated Radiation (4005 cGy) will last 3-4 weeks with 15 treatments, +/- 4 additional fractions as a boost. Radiation should commence within 180 days of the date of primary surgery. Four additional fractions (a "boost" or "conedown") to areas deemed to be at particularly high risk of recurrence may be added at the end of the radiation course. Fraction size for the boost treatment will continue at 267 cGy for an additional 1068 cGy in four fractions.

Find a Location

Who is running the clinical trial?

University of Colorado, DenverLead Sponsor
1,726 Previous Clinical Trials
2,141,564 Total Patients Enrolled
26 Trials studying Breast Cancer
6,401 Patients Enrolled for Breast Cancer
Christine Fisher, MD, MPHPrincipal InvestigatorUniversity of Colorado, Denver

Media Library

Adjuvant Hypofractionated Radiation (Radiation) Clinical Trial Eligibility Overview. Trial Name: NCT02700386 — Phase 2
Breast Cancer Research Study Groups: Adjuvant Hypofractionated Radiation
Breast Cancer Clinical Trial 2023: Adjuvant Hypofractionated Radiation Highlights & Side Effects. Trial Name: NCT02700386 — Phase 2
Adjuvant Hypofractionated Radiation (Radiation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02700386 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

May I partake in the experiment under consideration?

"At the moment, this medical trial is recruiting 112 individuals aged between 18 and 101 who have been diagnosed with breast cancer. Patients must meet certain criteria to be accepted into the study including: recovery from surgery without any infection or post-chemotherapy toxicity, Eastern Cooperative Oncology Group (ECOG) performance status of 0/1 (KPS >70%), AJCC 7th ed. Stage cN0 or cN1 subsequently staged after surgery as Stage pIB (N1mic), pIIA, pIIB, pIIIA, or pIIIB; those below 50 years old are also eligible if pathologic"

Answered by AI

Does this trial offer enrollment for seniors aged 60 and over?

"This clinical trial is seeking participants who are 18 years of age or older, but have yet to reach the century mark."

Answered by AI

What results are scientists hoping to achieve through this clinical trial?

"Over a span of 60 months, this clinical trial shall assess the prevalence of symptomatic rib fractures through plain film or CT scans. Additional secondary outcomes involve metrics such as metastasis-free survival (calculated from enrolment to detection of distant metastases and death), quality of life scores reported by EORTC QLQ-C3014 and breast cancer module (BR23), and recurrence rates within axillary lymph nodes I, II, III without supraclavicular region included."

Answered by AI

Are this trial's enrollment criteria still open for new participants?

"Unfortunately, clinicaltrials.gov does not list this trial as actively recruiting; the most recent update was made on August 30th 2022. Fortunately, 2600 other clinical studies are accepting participants at present."

Answered by AI

Has Adjuvant Hypofractionated Radiation been given regulatory approval yet?

"As this trial is in its second phase, there are data points that suggest adjuvant hypofractionated radiation's safety. Therefore the risk factor was assigned a score of 2."

Answered by AI
~9 spots leftby Dec 2024