| Principal Name | Harvey ZImbler, MD |
|---|---|
| Contact Name | Gloria Gero |
| Phone | (413) 496-8205 |
| Alternate Phone | (413) 443-6000 |
| Fax | (413) 443-2203 |
| Title | RTOG 1005 - " A Phase III Trial of Accelerated Whole Breast Irradiation with Hypofractionation Plus Concurrent Boostr Versus Standard Whole Breast Irradiaiton Plus Sequential Boost for Early-Stage Breast Cancer" |
| Description | Primary Objective To determine whether an accelerated course of hypofracionated WBI including a concomitant boost to the tumor bed in 15 fractions following lumpectomy will prove to be non-inferior in local control to a regimen of standard WBI with a sequential boost following lumpectomy for early-stage breast cancer patients. |
| Treatment | Oncology |
| Inclusion/Notes | ELIGIBILITY - Pathologically proven diagnosis of breast cancer reescted by lumpectomy and whole breast irradiaiton with boost without regional nodal irradiation planned - The patient must be female - pStage I, II Breast Cancer AND at least one of the following: Age <50 years Positive axillary nodes Lymphovascular space invasion ' More than 2 close resection margins (>0 mm to <2 mm) 1 close resection maragin and extensive in-situ compnnet (EIC) Focally positive rescetion margins Non-hormone sensitive breast cancer (ER and PR-negative) Grade III histology Oncotype recurrence score >25 - pStage 0 breast cancer with nuclear grade 3 DCIS and patient age <50 years - ypStage 0, I, II breast cancer resected by lumpectomy after neoadjuvant systemic therapy - Study entry must be within 42 days of last breast /axillary surgery and/or last chemotherapy - If multifocal brast cancer, then it must have been resected through a single lumpectomy incision with negative margins - Breast -conserving surgery with margins defined as follows: Negative margins defined as no tumor at resected specimen edge Close resection margins >0 mm to < 2mm A focally positive resection margin - Age > 18 - CT-imaging of the ipsilateral breast within 28 days of study entry for the radiation treatmnet planning. - Appropriate stage for procotol entry, including no clinical evidence for distant metastases based upon the following minimum diagnostic work up: H&P examination , including breast exam and documentaiton of weight and Zubrod Performance Status of 0-2 within 28 days prior to study entry: Bilateral mammogram within 6 months prior to study entry - CBC/differential obtained within 14 days prior to study entry, with adequate bone marrow function defined as follows: ANC >1800 cell/mm3 Platelets >75,000 cell/mm3 Hemoglobin >8.0 g/dl - Women of childbearing potential must have a negative serum pregnancy test wihtin 14 days of study entry - Women of childbearing potential must be non-pregnant and non-lactating and willing to use medically acceptable form of contraception during radiation therapy - Patient must provide study specific informed consent prior to study entry INELIGIBILTY - AJCC Pathologic T4,N2or N3, or M1 breast cancer - Treatment plan that includes regioal node irradiaiton - Prior invasive non-breast malignancy unless disease free for a minimu of 5 years prior to registration - Two or more breast cancers not resectaboe through a single lumpectomy incision - DCIS and age >50 years - DCIS and age < 50 years and nuclear grade 1 or 2 - Invasive breast cancer and low risk for 5-year in brest recurrence after lumpectomy with negative margins - Unable to delineate on CT scan the extent of the target lumpectomy cavity for boost - Suspicious unresected microcalicification, densities, or palpable abnormalities unless biopsied and found to be benign - Non-epithelial breast malignancies such as sarcoma or lymphoma - Pagets disease of the nipple - Male breast cancer - Prior radiotherapy to the breast or prior radiation to the region of the ipsilateral breast that would result in overlap of radiaiton therapy fields - Intention to administer concurrent chemotherapy for current breast cancer - Severe, active co-morbidity - Pregnancy or women of childbearing potential who are sexually active and not willing/able to use medically acceptable forms of contraception - Active systemic Lupus, erythematosus, or any history of scleroderma, dermatomyositis with active rash - Medical, psychiatric or other condition that would prevent the pateitn from receiving the protocol therapy or providing informed consent. |
| Status | accruing |
| Current Trial Type | treatment |
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