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Proton Beam Therapy

Proton Radiation for Breast Cancer

Phase 2
Waitlist Available
Research Sponsored by Proton Collaborative Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Must have had surgical treatment of the breast - either mastectomy or breast preserving surgery, such as lumpectomy. Re-excision of surgical margins is permitted.
Must be > = 18 years of age.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights

Study Summary

This trial is studying the long-term effects of proton therapy for locally advanced breast cancer.

Who is the study for?
This trial is for women over 18 with stage II/III breast cancer who've had surgery like a mastectomy or lumpectomy. They should expect to live at least another 10 years and agree to use non-hormonal contraception if of childbearing potential. Excluded are those with certain psychiatric, collagen diseases, pregnancy, weight over 410 pounds, large breast size unsuitable for treatment setup, prior non-breast cancers (with exceptions), unclear surgical margins without re-excision clearance, temporary breast expanders depending on assessment, previous chest radiation therapy, non-epithelial breast malignancies or a history of breast cancer.Check my eligibility
What is being tested?
The study tests postoperative proton radiotherapy's safety and long-term effects in advanced-stage breast cancer patients. It aims to monitor acute side effects and the risk of heart-related deaths and secondary cancers after up to 15 years following treatment.See study design
What are the potential side effects?
Potential side effects include skin reactions at the treatment site, fatigue during and after treatment sessions. Long-term risks being studied may involve heart complications or development of new cancers due to radiation exposure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have undergone surgery for breast cancer, like mastectomy or lumpectomy.
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I am 18 years old or older.
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My breast cancer is confirmed by tests and is of a specific type (invasive ductal or lobular).
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My cancer is classified as stage II or III.
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Excluding my breast cancer, I am expected to live 10 more years.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Determination of the rates of acute and late toxicities (acute and late adverse events) resulting from proton therapy radiation treatment.
Secondary outcome measures
Compare dosimetrically the dose volume histogram (DVH) of the PT plans with conventional external beam plans (either photon/electron intensity modulated radiotherapy(IMRT)plans, 3D-photon plans, or Tomotherapy plans).
Compare the different DVH parameters for the targets (D2, Dmean, Dmin, D95, V95, V110) and different OARs (as described later) of the PT plans with the corresponding values of the 3D-conformal radiation therapy (CRT), IMRT and Tomotherapy plans.
Determine dose distribution of proton therapy to coronary arteries, heart, ipsilateral and contralateral lung, and contralateral breast.
+3 more

Side effects data

From 2017 Phase 2 trial • 38 Patients • NCT00495040
3%
Pneumonitis
3%
Dermatitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Dose-escalated Proton Therapy for Early-stage Non-small Cell l

Trial Design

1Treatment groups
Experimental Treatment
Group I: Proton RadiotherapyExperimental Treatment1 Intervention
Proton Radiotherapy
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Proton Radiotherapy
2006
Completed Phase 2
~250

Find a Location

Who is running the clinical trial?

Proton Collaborative GroupLead Sponsor
9 Previous Clinical Trials
40,914 Total Patients Enrolled
2 Trials studying Breast Cancer
408 Patients Enrolled for Breast Cancer
Eugen Hug, MDStudy ChairProton Collaborative Group

Media Library

Proton Radiotherapy (Proton Beam Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT01758445 — Phase 2
Breast Cancer Research Study Groups: Proton Radiotherapy
Breast Cancer Clinical Trial 2023: Proton Radiotherapy Highlights & Side Effects. Trial Name: NCT01758445 — Phase 2
Proton Radiotherapy (Proton Beam Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01758445 — Phase 2

Frequently Asked Questions

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

Could you please walk me through the dangers of Proton Radiotherapy?

"While Phase 2 trials don't have data supporting efficacy, there is some evidence that suggests proton radiotherapy is safe. Consequently, our team rated it a 2."

Answered by AI

How many research facilities are coordinating this clinical trial?

"The following locations are conducting this research: Oklahoma Proton Center in Oklahoma City, Procure Proton Therapy Center in Baltimore, Maryland Proton Treatment Center in Hampton, Virginia. Plus, there are 6 other sites."

Answered by AI

Does this experiment need more participants?

"The clinicaltrials.gov website reveals that this trial is not looking for patients at the moment. The study was first posted on February 1st, 2013 and updated for the last time on October 24th, 2021. There are 2699 other trials recruiting right now though."

Answered by AI

Who else is applying?

What state do they live in?
California
How old are they?
18 - 65
What site did they apply to?
Northwestern Medicine Chicago Proton Center
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Proton Radiation for Stage II/III Breast Cancer
2013. "Proton Radiation for Stage II/III Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01758445.
~12 spots leftby Jan 2025
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