Proton Radiation for Stage II/III Breast Cancer (NCT01758445) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Proton Radiation for Stage II/III Breast Cancer
United States220 participantsStarted 2013-02
Plain-language 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).
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
What they're measuring
1
Determination of the rates of acute and late toxicities (acute and late adverse events) resulting from proton therapy radiation treatment.
. 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.