- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01758445
Proton Radiation for Stage II/III Breast Cancer
Phase II Study of Postoperative, Cardiac-Sparing Proton Radiotherapy for Patients With Stage II/III,Loco-Regional, Non-Metastatic Breast Cancer Requiring Whole Breast or Chest Wall Irradiation With Lymph Node Irradiation
Study Overview
Status
Intervention / Treatment
Detailed Description
The proposed Phase II study is seeking to build clinical data as a continuation of the original dosimetric analysis published by Ares et al. performed at Paul-Scherrer Institute (PSI). That comparison demonstrated a benefit form proton planning for patients with non-metastatic breast cancer requiring complex, loco-regional, postoperative radiotherapy.1 The advantages of PT were improved target coverage compared to standard photon irradiation and reduced dose to heart, lungs and contralateral breast.
The study goal is to demonstrate a "meaningful benefit" of proton therapy for women with loco-regionally advanced breast cancer. The main clinical endpoints of this trial are the reduction of cardiac morbidity and mortality (coronary artery disease, myocardial infarction, cardiac insufficiency) and the reduction of contralateral, second breast cancer. Both adverse events are presently associated with external beam photon therapy. Both goals require longitudinal follow-up of minimum 5-10 years. Despite the logistical challenges of long term follow-up, the effort is needed in view of the compelling preclinical evidence of dose avoidance or even absence of radiation dose to heart and contralateral breast uniquely accomplishable by protons only.
Study Type
Enrollment (Estimated)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Illinois
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Warrenville, Illinois, United States, 60555
- Northwestern Medicine Chicago Proton Center
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Maryland
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Baltimore, Maryland, United States, 21201
- Maryland Proton Treatment Center
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New Jersey
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Somerset, New Jersey, United States, 08873
- Princeton ProCure Managment LLC
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Oklahoma
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Oklahoma City, Oklahoma, United States, 73142
- Oklahoma Proton Center
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Virginia
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Hampton, Virginia, United States, 23666
- Hampton University Proton Therapy Institute
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Must sign study-specific, IRB approved informed consent form prior to study entry. Note consent by legally authorized representative is not allowed for this trial.
- Must be > = 18 years of age.
- Must have a life expectancy of at least 10 years based on age and comorbidities but excluding diagnosis of breast cancer.
- Must have pathology proven breast cancer. Pathology must be invasive ductal or lobular
- Must meet stage II - III group criteria per AJCC Staging manual 7th edition.
- Must have had surgical treatment of the breast - either mastectomy or breast preserving surgery, such as lumpectomy. Re-excision of surgical margins is permitted.
- Note: Multicentric breast cancer and Paget's disease of the nipple are permitted.
Exclusion Criteria:
- Weight over 410 pounds.
- Non-epithelial breast malignancies such as sarcoma or lymphoma.
- Surgical margins that cannot be microscopically assessed or are positive at pathologic evaluation. (If surgical margins are rendered free of disease by re-excision, the patient is eligible).
- Breast size exceeding the technical limitation of daily set-up reproducibility. This may be center-specific and will be assessed at the discretion of the treating center.
- Women with post-surgical temporary breast expanders will require individual assessment. Depending on the manufacturing product and other treatment planning-specific details the patient may be eligible or may be deemed ineligible, as determined by treating investigator.
- Prior history of breast cancer.
- Prior radiation to the breast or thorax.
- Collagen vascular disease, specifically dermatomyositis with a CPK level above normal or with an active skin rash, systemic lupus erythematosis, or scleroderma.
- Pregnancy or lactation at the time of proposed study entry. Women of reproductive potential must agree to use an effective non-hormonal method of contraception during therapy such as an intrauterine device or condom with spermicide. (Note: Women of childbearing potential must have a negative serum pregnancy test within 3 weeks of study registration).
- Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements.
- Prior history of non-breast malignancies unless they have been disease free for 5 or more years and are deemed by their physician to be at low risk for recurrence. Further, patients who have the following cancers treated within the prior 5 years are permitted: carcinoma in situ of the cervix, carcinoma in situ of the colon, melanoma in situ, basal cell or squamous cell carcinoma of the skin.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Proton Radiotherapy
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Radiation therapy will be given once a day.
Minimum of 28 treatments and may receive 6-9 additional treatments as determined by protocol & physician.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Determination of the rates of acute and late toxicities (acute and late adverse events) resulting from proton therapy radiation treatment.
Time Frame: 5 years
|
5 years
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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).
Time Frame: On average at 9 weeks post start of treatment
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On average at 9 weeks post start of treatment
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Incidence rates of local control, regional control, metastatic status and disease free overall survival.
Time Frame: 5 years
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5 years
|
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.
Time Frame: On average at 9 weeks post start of treatment
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On average at 9 weeks post start of treatment
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Determine dose distribution of proton therapy to coronary arteries, heart, ipsilateral and contralateral lung, and contralateral breast.
Time Frame: On average at 9 weeks post start of treatment
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On average at 9 weeks post start of treatment
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Determine the incidence of clinically symptomatic coronary artery disease, cardiac morbidity and mortality in general and incidence of secondary malignancy, including contralateral breast cancer
Time Frame: 5 years
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5 years
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Evaluate quality of life results.
Time Frame: 5 years
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5 years
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Eugen Hug, MD, Proton Collaborative Group
Study record dates
Study Major Dates
Study Start
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BRE008-12
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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