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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
- 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
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

- 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
- 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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