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

Who is this study for? Patients with Breast Cancer
What treatments are being studied? Proton Radiotherapy
Status: Active_not_recruiting
Location: See all (5) locations...
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
Illinois
Northwestern Medicine Chicago Proton Center
Warrenville
Maryland
Maryland Proton Treatment Center
Baltimore
New Jersey
Princeton ProCure Managment LLC
Somerset
Oklahoma
Oklahoma Proton Center
Oklahoma City
Virginia
Hampton University Proton Therapy Institute
Hampton
Time Frame
Start Date: 2013-02
Completion Date: 2030-01
Participants
Target number of participants: 220
Treatments
Experimental: Proton Radiotherapy
Proton Radiotherapy
Related Therapeutic Areas
Sponsors
Leads: Proton Collaborative Group

This content was sourced from clinicaltrials.gov