Proton Radiation for Stage II/III Breast Cancer
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|ClinicalTrials.gov Identifier: NCT01758445|
Recruitment Status : Active, not recruiting
First Posted : January 1, 2013
Last Update Posted : April 4, 2023
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|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer Breast Neoplasm Breast Tumor Cancer of the Breast||Radiation: Proton Radiotherapy||Phase 2|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||220 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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 Start Date :||February 2013|
|Estimated Primary Completion Date :||January 2025|
|Estimated Study Completion Date :||January 2030|
Experimental: Proton Radiotherapy
Radiation: Proton Radiotherapy
Radiation therapy will be given once a day. Minimum of 28 treatments and may receive 6-9 additional treatments as determined by protocol & physician.
- Determination of the rates of acute and late toxicities (acute and late adverse events) resulting from proton therapy radiation treatment. [ Time Frame: 5 years ]
- 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 ]
- Incidence rates of local control, regional control, metastatic status and disease free overall survival. [ Time Frame: 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 ]
- 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 ]
- 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 ]
- Evaluate quality of life results. [ Time Frame: 5 years ]
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01758445
|United States, Illinois|
|Northwestern Medicine Chicago Proton Center|
|Warrenville, Illinois, United States, 60555|
|United States, Maryland|
|Maryland Proton Treatment Center|
|Baltimore, Maryland, United States, 21201|
|United States, New Jersey|
|Princeton ProCure Managment LLC|
|Somerset, New Jersey, United States, 08873|
|United States, Oklahoma|
|Oklahoma Proton Center|
|Oklahoma City, Oklahoma, United States, 73142|
|United States, Virginia|
|Hampton University Proton Therapy Institute|
|Hampton, Virginia, United States, 23666|
|Study Chair:||Eugen Hug, MD||Proton Collaborative Group|
|Responsible Party:||Proton Collaborative Group|
|Other Study ID Numbers:||
|First Posted:||January 1, 2013 Key Record Dates|
|Last Update Posted:||April 4, 2023|
|Last Verified:||April 2023|
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