Proton Radiation for Stage II/III Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01758445
Recruitment Status : Recruiting
First Posted : January 1, 2013
Last Update Posted : January 18, 2018
Information provided by (Responsible Party):
Proton Collaborative Group

December 14, 2012
January 1, 2013
January 18, 2018
February 2013
January 2022   (Final data collection date for primary outcome measure)
Determination of the rates of acute and late toxicities (acute and late adverse events) resulting from proton therapy radiation treatment. [ Time Frame: 5 years ]
Same as current
Complete list of historical versions of study NCT01758445 on Archive Site
  • 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 ]
Same as current
Not Provided
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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
The purpose of this study is to look at the rates of acute and long term adverse events of postoperative proton radiotherapy for complex loco-regional irradiation in women with loco-regionally advanced breast cancer. This study specifically includes longitudinal follow up to assess the incidence of cardiac mortality and second malignant neoplasms at 10 and 15 years following proton therapy(PT).

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.

Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Breast Cancer
  • Breast Neoplasm
  • Breast Tumor
  • Cancer of the Breast
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.
Experimental: Proton Radiotherapy
Proton Radiotherapy
Intervention: Radiation: Proton Radiotherapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
January 2030
January 2022   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. 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.
  2. Must be > = 18 years of age.
  3. Must have a life expectancy of at least 10 years based on age and comorbidities but excluding diagnosis of breast cancer.
  4. Must have pathology proven breast cancer. Pathology must be invasive ductal or lobular
  5. Must meet stage II - III group criteria per AJCC Staging manual 7th edition.
  6. Must have had surgical treatment of the breast - either mastectomy or breast preserving surgery, such as lumpectomy. Re-excision of surgical margins is permitted.
  7. Note: Multicentric breast cancer and Paget's disease of the nipple are permitted.

Exclusion Criteria:

  1. Weight over 410 pounds.
  2. Non-epithelial breast malignancies such as sarcoma or lymphoma.
  3. 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).
  4. 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.
  5. 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.
  6. Prior history of breast cancer.
  7. Prior radiation to the breast or thorax.
  8. Collagen vascular disease, specifically dermatomyositis with a CPK level above normal or with an active skin rash, systemic lupus erythematosis, or scleroderma.
  9. 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).
  10. Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements.
  11. 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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact: Corey Woods, RN, MS, CCRC 630-836-8668
United States
Not Provided
Not Provided
Proton Collaborative Group
Proton Collaborative Group
Not Provided
Study Chair: Eugen Hug, MD Proton Collaborative Group
Proton Collaborative Group
January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP