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Full Protocol
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RTOG 1005 - "A Phase III Trial of Accelerated Whole Breast Irradiation with Hypofractionation plus Concurrent Boost versus Standard Whole Breast Irradiation plus Sequential Boost for Early-Stage Breast Cancer"
NOTE: Institutions must be credentialed for 3D-CRT or IMRT on this protocol. Visit the Radiological Physics Center (RPC) website & select "Credentialing". Also see protocol Section 5.0 for further details.
Treatment Plan (Supplied Drug: N/A)
Arm 1 - Standard Fractionation
Whole Breast: 50.0Gy/25 fx/2.0Gy, daily
Optional Fractionation: 42.7Gy in 16 fx permissible
Sequential Boost: 12Gy/6 fx/2.0 daily or 14.0Gy/7 fx/2.0Gy daily
Arm 2 - Hypofractionation (15 fx total)
Whole Breast: 40Gy/15 fx/2.67Gy daily
Concurrent Boost: 48.0Gy/3.2Gy daily
Eligibility
Path-proven breast cancer resected by lumpectomy & whole breast RT & boost w/o regional lymph node RT planned.
Must be female.
pStage I, II and >1 of following:
Age <50
Positive axillary nodes
Lymphovascular space invasion
>2 close resection margins (>0mm to <2mm)
1 close resection margin & extensive in-situ component (EIC)
Focally positive resection margins
Non-hormone sensitive breast cancer (ER & PR-negative)
Grade III histology
Oncotype recurrence score >25
pStage 0 w/nuclear grade 3 DCIS & age <50.
ypStage 0, I, II resected by lumpectomy after neo-adjuv systemic therapy
Study entry w/i 42 days of last breast/axillary surgery &/or last chemo.
If multifocal breast cancer, must have been resected through a single lumpectomy incision w/negative margins.
Breast-conserving surgery w/margins defined as:
No tumor at resected specimen edge
Close resection margins >0mm to <2mm
1 close resection margin & EIC
>2 close resection margins
A focally positive resection margin
Allowable margins for mandatory axillary staging include:
Sentinel node bx alone (if SN is negative, pN0, pN0(IHC-,+)
SN bx alone, or followed by axillary node dissection, for clinically node negative pts as follows:
Microscopic sentinel node positive (pN1mic)
1-2 SNs positive (pN1) w/o extracapsular extention & pT1 or pT2 & >1 additional negative SN
SN bx followed by axillary dissection w/>6 axillary nodes if any of the following exist:
>2 positive SNs
Solitary SN that is positive w/o other SNs dissected
Clinical (by imaging or exam) T3 disease
>1 positive SN w/extracapsular extension, clinically node-positive disease, or LVI in prim tumor
Axillary dissection alone (>6 axillary nodes)
Age >18.
CT of ipsilateral breast w/i 28 days pre-study entry for RT tx planning. Must be able to delineate on CT the extent of the target lumpectomy cavity for boost. Placement of surgical clips is strongly recommended - see Section 6.4.2.1a).
No evidence for distant mets.
Within 14 days pre-study entry: ANC >1800 cells/mm3; platelets >75,000 cells/mm3; Hgb >8.0g/dl (transfusion or other intervention to achieve Hgb is allowed); negative serum pregnancy test (if applicable).
No pregnant or nursing women. Must use effective contraception during RT.
No AJCC path T4, N2-N3, or M1 breast cancer.
No prior invasive non-breast malignancy (except non-melanoma skin or cervical carcinoma in situ) unless disease-free >5 yrs pre-regist.
No prior invasive or in situ breast carcinoma (prior LCIS is allowed).
Invasive breast cancer & low risk for 5-yr in breast recurrence post-lumpectomy w/negative margins unless meeting 1 of criteria Bullet 3 above:
>70, T1, N0, ER/PR positive
>50, T1, N0, Grade 1-2 breast cancer, ER/PR positive
No suspicious unresected microcalcifications, densities, or palpable abnormalities (in ipsilateral or contralateral breast) unless biopsied & found benign.
No non-epithelial breast malignancies.
No Paget's disease of nipple.
No prior RT to breast or region or ipsilateral breast resulting in overlap of RT fields.
No plans for concurrent chemo for current breast cancer.
No unstable angina &/or CHF requiring hospitalization w/i last 6 mos.
No transmural MI w/i last 6 mos.
No acute bacterial or fungal infection requiring IV antibiotics at regist.
No COPD exacerbation or other respiratory illness requiring hospitalization or precluding study therapy w/i 30 days pre-regist.
No hepatic insufficiency resulting in clinical jaundice &/or coagulation defects (liver function & coagulation lab tests are not required for study entry).
No AIDS pts based on current CDC definition (HIV test is not required for study entry).
No active systemic lupus, erythematosus, prior scleroderma, or dermatomyositis w/active rash.
No medical, psychiatric, or other condition to preclude protocol therapy or informed consent.
PRESTUDY REQUIREMENTS:
Lumpectomy/Final Surgeries (w/i 42 days pre-study entry)
H&P, breast exam, wt, perf status*
Bilat mammogram**
CT ipsilateral breast for tx planning*#
CBC/diff/ANC##
Serum pregnancy test (if applicable)##
AJCC TNM staging**
CXR or CT chest (recommended)**
Bone scan (recommended if abnormal alk phos or new/unusual bone pain; required for positive nodes)**
CT chest/abdomen/pelvis or PET/CT (recommended if abnormal LFTs or new/unusual somatic complaints; required for positive axillary nodes)**
Negative post-excision mammogram (recommended if malignancy-associated calcifications post-lumpectomy)**
Research specimens (contact KCCOP for kit)***###
Doctor cosmetic asmt (questionnaire & photos)***
Pt questionnaire (cosmesis/QOL study)***
* Within 28 days pre-study entry
** Within 6 mos pre-study entry
*** With pt's consent & prior to start of RT
# Tumor bed must be clearly delineated for creating a clinical target volume (preferably w/surgical clips) for RT boost.
## Within 14 days pre-study entry
### H&E stained slides & PE tissue block or punch bx (tumor & normal tissue on all specimens) shipped ambient. Two 5-10mL tubes whole blood in EDTA (purple/lavender top) for plasma & DNA (send frozen on dry ice via overnight carrier, Mon-Wed only). Send all specimens to RTOG Biospecimen Resource; San Francisco, CA (note different addresses for frozen vs non-frozen specimens).
Signed informed consent.