Higher Per Daily Treatment-Dose Radiation Therapy or Standard Per Daily Treatment Radiation Therapy in Treating Patients With Early-Stage Breast Cancer That Was Removed by Surgery
Status: | Active, not recruiting |
---|---|
Conditions: | Breast Cancer, Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 8/30/2018 |
Start Date: | May 2011 |
End Date: | August 2024 |
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
RATIONALE: It is not yet know whether higher per daily radiation therapy is equally as
effective as standard per daily radiation therapy in treating breast cancer.
PURPOSE: This randomized phase III trial studies how well an accelerated course of higher per
daily radiation therapy with concomitant boost works compared to standard per daily radiation
therapy with a sequential boost in treating patients with early-stage breast cancer that was
removed by surgery.
effective as standard per daily radiation therapy in treating breast cancer.
PURPOSE: This randomized phase III trial studies how well an accelerated course of higher per
daily radiation therapy with concomitant boost works compared to standard per daily radiation
therapy with a sequential boost in treating patients with early-stage breast cancer that was
removed by surgery.
OBJECTIVES:
Primary
- To determine whether an accelerated course of hypofractionated whole-breast irradiation
(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.
Secondary
- To determine whether breast-related symptoms and cosmesis from accelerated WBI that is
hypofractionated (in only 3 weeks) with a concomitant boost is non-inferior to standard
WBI with sequential boost.
- To determine whether the risk of late cardiac toxicity in patients with left-sided
breast cancer treated with hypofractionation will be non-inferior to conventional
fractionated radiation therapy (RT) based upon analysis of radiation dosimetry from
CT-based treatment planning and NTCP calculations.
- To determine whether CT-based conformal methods intensity-modulated radiation therapy
(IMRT) and three-dimensional conformal radiotherapy (3D-CRT) for WBI are feasible in a
multi-institutional setting following lumpectomy in early-stage breast cancer patients
and whether dose-volume analyses can be established to assess treatment adequacy and
likelihood of toxicity.
- To determine that cosmetic results and breast-related symptoms 3 years after
hypofractionated breast radiation with concomitant boost will not be inferior to that
obtained 3 years after WBI with sequential boost.
- To determine whether future correlative studies can identify individual gene expressions
and biological host factors associated with toxicity and/or local recurrence from
standard and hypofractionated WBI.
- If shown to be non-inferior, to then determine if accelerated course of hypofractionated
WBI including a concomitant boost to the tumor bed in 15 fractions following lumpectomy
will prove to be superior in local control to a regimen of standard WBI with a
sequential boost following lumpectomy for early-stage breast cancer patients.
- To determine whether treatment costs for hypofractionated WBI with concomitant boost are
not higher than WBI with sequential boost.
OUTLINE: This is a multicenter study. Patients are stratified according to age (< 50 vs. ≥ 50
years), prior chemotherapy (yes vs. no), estrogen-receptor status (+ vs. -), and histology
grade (1-2 vs. 3). Patients are randomized to 1 of 2 treatment arms. Treatment begins within
9 weeks of last surgery or chemotherapy delivery.
- Arm I: Patients undergo standard whole-breast radiotherapy (WBI) comprising
intensity-modulated radiation therapy (IMRT) or three-dimensional conformal radiotherapy
(3D-CRT) 5 days a week for 3-5 weeks followed by a sequential radiotherapy boost to the
lumpectomy area 5 days a week for 1-1½ weeks. Treatment continues in the absence of
disease progression or unacceptable toxicity.
- Arm II: Patients undergo accelerated hypofractionated WBI comprising IMRT or 3D-CRT with
a concurrent boost to the lumpectomy area 5 days a week for 3 weeks. Treatment continues
in the absence of disease progression or unacceptable toxicity.
Patients' tissue samples may be collected for future research studies.
After completion of study therapy, patients are followed at 1 month, at 6 months, and then
yearly.
Primary
- To determine whether an accelerated course of hypofractionated whole-breast irradiation
(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.
Secondary
- To determine whether breast-related symptoms and cosmesis from accelerated WBI that is
hypofractionated (in only 3 weeks) with a concomitant boost is non-inferior to standard
WBI with sequential boost.
- To determine whether the risk of late cardiac toxicity in patients with left-sided
breast cancer treated with hypofractionation will be non-inferior to conventional
fractionated radiation therapy (RT) based upon analysis of radiation dosimetry from
CT-based treatment planning and NTCP calculations.
- To determine whether CT-based conformal methods intensity-modulated radiation therapy
(IMRT) and three-dimensional conformal radiotherapy (3D-CRT) for WBI are feasible in a
multi-institutional setting following lumpectomy in early-stage breast cancer patients
and whether dose-volume analyses can be established to assess treatment adequacy and
likelihood of toxicity.
- To determine that cosmetic results and breast-related symptoms 3 years after
hypofractionated breast radiation with concomitant boost will not be inferior to that
obtained 3 years after WBI with sequential boost.
- To determine whether future correlative studies can identify individual gene expressions
and biological host factors associated with toxicity and/or local recurrence from
standard and hypofractionated WBI.
- If shown to be non-inferior, to then determine if accelerated course of hypofractionated
WBI including a concomitant boost to the tumor bed in 15 fractions following lumpectomy
will prove to be superior in local control to a regimen of standard WBI with a
sequential boost following lumpectomy for early-stage breast cancer patients.
- To determine whether treatment costs for hypofractionated WBI with concomitant boost are
not higher than WBI with sequential boost.
OUTLINE: This is a multicenter study. Patients are stratified according to age (< 50 vs. ≥ 50
years), prior chemotherapy (yes vs. no), estrogen-receptor status (+ vs. -), and histology
grade (1-2 vs. 3). Patients are randomized to 1 of 2 treatment arms. Treatment begins within
9 weeks of last surgery or chemotherapy delivery.
- Arm I: Patients undergo standard whole-breast radiotherapy (WBI) comprising
intensity-modulated radiation therapy (IMRT) or three-dimensional conformal radiotherapy
(3D-CRT) 5 days a week for 3-5 weeks followed by a sequential radiotherapy boost to the
lumpectomy area 5 days a week for 1-1½ weeks. Treatment continues in the absence of
disease progression or unacceptable toxicity.
- Arm II: Patients undergo accelerated hypofractionated WBI comprising IMRT or 3D-CRT with
a concurrent boost to the lumpectomy area 5 days a week for 3 weeks. Treatment continues
in the absence of disease progression or unacceptable toxicity.
Patients' tissue samples may be collected for future research studies.
After completion of study therapy, patients are followed at 1 month, at 6 months, and then
yearly.
DISEASE CHARACTERISTICS:
- Pathologically proven diagnosis of breast cancer resected by lumpectomy and
whole-breast irradiation (WBI) with boost without regional nodal irradiation planned
- Must meet one of the following three criteria:
- pStage I or II breast cancer AND at least one of the following:
- Age < 50 years or
- Positive axillary nodes or
- Lymphovascular space invasion (LVI) or
- At least 2 close resection margins (> 0 mm to ≤ 2 mm) or
- One close resection margin and extensive in-situ component (EIC) or
- Focally positive resection margins or
- Non-hormone-sensitive breast cancer (estrogen and progesterone receptor
negative (ER- and PR-) or
- Grade III histology or
- Oncotype recurrence score > 25 or
- pStage 0 breast cancer with nuclear grade 3 ductal carcinoma in situ (DCIS) and
patient age < 50 years or
- If multifocal breast 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 the resected specimen edge
- Close resection margins > 0 mm to ≤ 2 mm as follows:
- One close resection margin and EIC
- Two or more close resection margins
- A focally positive resection margin
- Allowable options for mandatory axillary staging include:
- Sentinel node biopsy alone (if sentinel node is negative, pN0, pN0[IHC-,+])
- Sentinel node biopsy alone, OR followed by axillary node dissection, for
clinically node-negative patients as described below:
- Microscopic sentinel node (SN) positive (pN1mic)
- One or two SNs positive (pN1) without extracapsular extension
- Negative SN biopsy after neoadjuvant chemotherapy
- Axillary node dissection is required following SN biopsy with a minimum total of
6 axillary nodes if any of the following exist:
- For > 2 positive SN
- Any positive SN biopsy after neoadjuvant chemotherapy
- For clinically (by either imaging or examination) T3 disease
- For extracapsular extension
- Axillary dissection alone (with a minimum of 6 axillary nodes)
- CT-imaging of the ipsilateral breast within 28 days of study entry for the radiation
treatment planning.
- Must be able to delineate on CT scan the extent of the target lumpectomy cavity
for boost (placement of surgical clips to assist in treatment planning of the
boost is strongly recommended)
- No clinical evidence for distant metastases, based upon the following minimum
diagnostic workup:
- History/physical examination, including breast exam (inspection and palpation of
the breasts) and documentation of weight and Zubrod Performance Status of 0-2
within 28 days prior to study entry
- A mammogram of both right and left breast within only 1 time point of 90 days of
the diagnostic biopsy establishing the diagnosis
- No prior invasive or in-situ carcinoma of the breast (prior LCIS is eligible)
- No American Joint Committee on Cancer (AJCC) pathologic T4, N2 or N3, or M1 breast
cancer
- Must not have two or more breast cancers that are not resectable through a single
lumpectomy incision
- Must not be DCIS and ≥ 50 years old
- Must not be DCIS only (without an invasive component), nuclear grade 1 or 2 and < 50
years old
- No suspicious unresected microcalcification, densities, or palpable abnormalities (in
the ipsilateral or contralateral breast) unless biopsied and found to be benign
- No non-epithelial breast malignancies such as sarcoma or lymphoma
- No Paget disease of the nipple
- No male breast cancer
- Breast implants allowed
PATIENT CHARACTERISTICS:
- ANC ≥ 1,800/mm³
- Platelet count ≥ 75,000/mm³
- Hemoglobin ≥ 8.0 g/dL (transfusion or other intervention to achieve Hgb ≥ 8.0 g/dL is
acceptable)
- Negative urine or serum pregnancy test within 14 days of study entry
- Women of childbearing potential must not be pregnant or nursing and willing to use
medically acceptable form of contraception during radiotherapy
- No prior invasive non-breast malignancy (except non-melanomatous skin cancer or
carcinoma in situ of the cervix) unless disease free for a minimum of 5 years prior to
study entry
- No severely active co-morbidity, defined as follows:
- Unstable angina and/or congestive heart failure requiring hospitalization within
the last 6 months
- Transmural myocardial infarction within the past 6 months
- Acute bacterial or fungal infection requiring intravenous antibiotics at the time
of registration
- Chronic obstructive pulmonary disease exacerbation or other respiratory illness
requiring hospitalization or precluding study therapy within 30 days before
registration
- Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects;
note, however, that laboratory tests for liver function and coagulation
parameters are not required for entry into this protocol
- Acquired Immune-Deficiency Syndrome (AIDS) based upon current CDC definition
- HIV testing is not required for entry into this protocol
- No active systemic lupus, erythematosus, or any history of scleroderma or
dermatomyositis with active rash
- Medical, psychiatric, or other condition that would prevent the patient from receiving
the protocol therapy or providing informed consent
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- Study entry must be within 50 days of last breast/axillary surgery and/or last
chemotherapy
- No treatment plan that includes regional-node radiotherapy
- No prior radiotherapy to the breast or prior radiation to the region of the
ipsilateral breast that would result in overlap of radiation therapy fields
- No intention to administer concurrent chemotherapy for current breast cancer
We found this trial at
383
sites
Newton-Wellesley Hospital A comprehensive medical center located right in Newton on Washington Street, Newton-Wellesley Hospital...
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529 West Markham Street
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Little Rock, Arkansas 72205
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2279 45th Street
Sacramento, California 95817
Sacramento, California 95817
(916) 734-5800
University of California Davis Cancer Center At UC Davis Comprehensive Cancer Center, specialized teams of...
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4502 Medical Drive
San Antonio, Texas 78284
San Antonio, Texas 78284
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601 South Sherman Street
Spokane, Washington 99202
Spokane, Washington 99202
(509) 228-1000
Cancer Care Northwest - Spokane South Cancer Care Northwest is the Inland Northwest’s premier cancer...
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12902 USF Magnolia Dr
Tampa, Florida 33612
Tampa, Florida 33612
(888) 663-3488
H. Lee Moffitt Cancer Center & Research Institute Moffitt Cancer Center in Tampa, Florida, has...
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Northside Hospital Northside Hospital-Atlanta (in Sandy Springs) opened in 1970. The original facility had 250...
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Piedmont Hospital For more than a century, Piedmont Healthcare has been a recognized leader in...
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5665 Peachtree Dunwoody Rd NE
Atlanta, Georgia 30342
Atlanta, Georgia 30342
(678) 843-7001
Saint Joseph's Hospital of Atlanta Founded by the Sisters of Mercy in 1880, Saint Joseph
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13001 E. 17th Pl.
Aurora, Colorado 80045
Aurora, Colorado 80045
303-724-5000
University of Colorado Cancer Center - Anschutz Cancer Pavilion The University of Colorado Denver |...
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Rush - Copley Medical Center Rush-Copley is proud to be the leading provider of health...
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22 South Greene Street
Baltimore, Maryland 21201
Baltimore, Maryland 21201
410-328-7904
University of Maryland Greenebaum Cancer Center The University of Maryland Marlene and Stewart Greenebaum Cancer...
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Greater Baltimore Medical Center The 255-bed medical center (acute and sub-acute care) is located on...
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Summa Barberton Hospital Summa Barberton Hospital is a full member of Summa Health System and...
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136 Mountainview Blvd
Basking Ridge, New Jersey 7920
Basking Ridge, New Jersey 7920
(908) 542-3000
Memorial Sloan-Kettering Cancer Center - Basking Ridge At Memorial Sloan Kettering Basking Ridge, we offer...
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Sanford Clinic North-Bemidgi Sanford Health is a voluntary, not-for-profit health care organization. Through its entities,...
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8901 Rockville Pike
Bethesda, Maryland 20889
Bethesda, Maryland 20889
(301) 295-4000
Walter Reed National Military Medical Center The Walter Reed National Military Medical Center is one...
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Billings Clinic Based in Billings, Montana, Billings Clinic is a community-governed health care organization consisting...
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Sanford Bismarck Medical Center Whether your stay in our hospital is one day for same...
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Saint Alphonsus Regional Medical Center Saint Alphonsus Health System is a four-hospital regional, faith-based Catholic...
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Massachusetts General Hospital Cancer Center An integral part of one of the world
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Bryn Mawr Hospital Bryn Mawr Hospital, a nationally recognized community teaching hospital, is conveniently located...
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171 Ashley Avenue
Charleston, South Carolina 29425
Charleston, South Carolina 29425
843-792-1414
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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Saint Luke's Hospital St. Luke's Hospital, located in Chesterfield, Missouri, is a regional healthcare provider...
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Adena Regional Medical Center Since 1895, Adena Health System has remained focused on its commitment...
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University of Cincinnati The University of Cincinnati offers students a balance of educational excellence and...
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The Christ Hospital For more than 120 years, The Christ Hospital has been a leader...
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9280 SE Sunnybrook Blvd #100
Clackamas, Oregon 97015
Clackamas, Oregon 97015
(503) 513-3300
Clackamas Radiation Oncology Center State-of-the-art technology and compassionate care come together at Clackamas Radiation Oncology...
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Case Western Reserve Univ Continually ranked among America's best colleges, Case Western Reserve University has...
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18101 Lorain Avenue
Cleveland, Ohio 44111
Cleveland, Ohio 44111
216.476.7000
Cleveland Clinic Cancer Center at Fairview Hospital Fairview Hospital is a 488-bed hospital located at...
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Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
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Mercy Cancer Center - West Lakes When it comes to cancer care, there
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Penrose-Saint Francis Healthcare Founded by the Sisters of St. Francis and the Sisters of Charity,...
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650 Commack Rd
Commack, New York 11725
Commack, New York 11725
(631) 623-4000
Memorial Sloan-Kettering Cancer Center at Commack Memorial Sloan Kettering Cancer Center - the world's oldest...
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University of Texas Southwestern Medical Center UT Southwestern is an academic medical center, world-renowned for...
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Geisinger Medical Center Since 1915, Geisinger Medical Center has been known as the region’s resource...
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Decatur Memorial Hospital An American flag bearing only 48 stars waved above Decatur Memorial Hospital...
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Deerfield Beach, Florida 33442
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Porter Adventist Hospital Founded in 1930, Porter Adventist Hospital has provided people throughout Denver and...
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