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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

Description

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.

Phase

N/A

Inclusion and Exclusion Criteria

  • 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

Sites

  • California

    • 21st Century Oncology - El Segundo, El Segundo, California, 90245
    • University of California at Los Angeles (UCLA ), Los Angeles, California, 90095
    • UC San Diego Moores Cancer Center, LA Jolla, California, 92093
    • Santa Clara Valley Medical Center, San Jose, California, 95128
    • Kaiser Permanente Radiation Oncology Cancer Treatment Center, Santa Clara, California, 95051
    • Epic Care-Dublin, Dublin, California, 94568
    • Kaiser Permanente Oakland-Broadway, Oakland, California, 94611
    • South Sacramento Cancer Center, Sacramento, California, 95823
    • Kaiser Permanente-Rancho Cordova Cancer Center, Rancho Cardova, California, 95670
    • The Permanente Medical Group-Roseville Radiation Oncology, Roseville, California, 95678
    • Enloe Medical Center, Chico, California, 95926
  • Nevada

    • Comprehensive Cancer Centers of Nevada, Las Vegas, Nevada, 89148
    • Radiation Oncology Centers of Nevada Central, Las Vegas, Nevada, 89106
    • Renown Regional Medical Center, Reno, Nevada, 89502
    • Saint Mary's Regional Medical Center, Reno, Nevada, 89503
  • Arizona

    • 21st Century Oncology-Scottsdale, Scottsdale, Arizona, 85251
    • Arizona Oncology Associates-West Orange Grove, Tucson, Arizona, 85704
  • Utah

    • McKay-Dee Hospital Center, Ogden, Utah, 84403
  • Oregon

    • Providence Medford Medical Center, Medford, Oregon, 97504
    • Three Rivers Community Hospital, Grants Pass, Oregon, 97527
    • Willamette Valley Cancer Center, Eugene, Oregon, 97401
  • New Mexico

    • Memorial Medical Center - Las Cruces, Las Cruces, New Mexico, 88011
  • Colorado

    • The Shaw Regional Cancer Center, Edwards, Colorado, 81632
  • Washington

    • Tri-Cities Cancer Center, Kennewick, Washington, 99336
    • Cancer Care Northwest-North Spokane, Spokane, Washington, 99218
    • Olympic Medical Cancer Care Center, Sequim, Washington, 98384
    • Harrison Medical Center, Bremerton, Washington, 98310
  • Texas

    • West Texas Cancer Center, Odessa, Texas, 79761
    • Texas Oncology-Wichita Falls Texoma Cancer Center, Wichita Falls, Texas, 76310
    • Texas Oncology-Seton Williamson, Round Rock, Texas, 78665
    • Brooke Army Medical Center, Fort Sam Houston, Texas, 78234
    • Cancer Care Centers of South Texas- Northeast, San Antonio, Texas, 78217
    • Texas Oncology-Denton South, Denton, Texas, 76210
    • Texas Oncology - Round Rock Cancer Center, Round Rock, Texas, 78681
    • Texas Oncology-Arlington South, Arlington, Texas, 76014
    • Texas Oncology - Lewisville, Lewisville, Texas, 75067
    • Texas Oncology - South Austin Cancer Center, Austin, Texas, 78745
    • Texas Oncology-Austin Midtown, Austin, Texas, 78705
    • Baylor Medical Center at Irving, Irving, Texas, 75061
    • Texas Oncology-Plano West, Plano, Texas, 75093
  • South Dakota

    • Avera Cancer Institute, Sioux Falls, South Dakota, 57105
  • Missouri

    • Liberty Hospital, Liberty, Missouri, 64068
    • Saint Luke's Hospital, Chesterfield, Missouri, 63017
    • Cape Radiation Oncology, Cape Girardeau, Missouri, 63703
  • Iowa

    • Mercy Cancer Center-West Lakes, Clive, Iowa, 50325
    • Mercy Medical Center - Des Moines, Des Moines, Iowa, 50314
    • Iowa Methodist Medical Center, Des Moines, Iowa, 50309
    • Finley Hospital, Dubuque, Iowa, 52001
  • Arkansas

    • Mercy Cancer Center-Hot Springs, Hot Springs, Arkansas, 71913
  • North Dakota

    • Altru Cancer Center, Grand Forks, North Dakota, 58201
  • Minnesota

    • Mayo Clinic Health Systems-Mankato, Mankato, Minnesota, 56001
    • Mayo Clinic Health System in Albert Lea, Albert Lea, Minnesota, 56007
    • Miller-Dwan Hospital, Duluth, Minnesota, 55805
  • Wisconsin

    • Mayo Clinic Health System-Franciscan Healthcare, La Crosse, Wisconsin, 54601
    • Mayo Clinic Health System Eau Claire Hospital - Luther Campus, Eau Claire, Wisconsin, 54703
    • University of Wisconsin Hospital and Clinics, Madison, Wisconsin, 53792
    • Beloit Memorial Hospital, Beloit, Wisconsin, 53511
    • Aspirus Regional Cancer Center, Wausau, Wisconsin, 54401
    • UW Cancer Center Johnson Creek, Johnson Creek, Wisconsin, 53038
    • Langlade Hospital and Cancer Center, Antigo, Wisconsin, 54409
    • Agnesian Cancer Center, Fond Du Lac, Wisconsin, 54935
    • Community Memorial Hospital, Menomonee Falls, Wisconsin, 53051
    • Aurora West Allis Medical Center, West Allis, Wisconsin, 53227
    • Aurora Saint Luke's Medical Center, Milwaukee, Wisconsin, 53215
    • Bellin Memorial Hospital, Green Bay, Wisconsin, 54301
    • Vince Lombardi Cancer Clinic-Sheboygan, Sheboygan, Wisconsin, 53081
    • Vince Lombardi Cancer Clinic, Two Rivers, Wisconsin, 54241
  • Illinois

    • Saint John's Hospital, Springfield, Illinois, 62702
    • FHN Leonard C. Ferguson Cancer Center, Freeport, Illinois, 61032
    • Community Cancer Center Foundation, Normal, Illinois, 61761
    • Rush - Copley Medical Center, Aurora, Illinois, 60504
    • Advocate Lutheran General Hospital., Park Ridge, Illinois, 60068
    • Advocate Illinois Masonic Medical Center, Chicago, Illinois, 60657
  • Louisiana

    • Tulane University Health Sciences Center, New Orleans, Louisiana, 70112
  • Mississippi

    • Singing River Hospital, Pascagoula, Mississippi, 39581
  • Kentucky

    • Owensboro Health Mitchell Memorial Cancer Center, Owensboro, Kentucky, 42303
  • Indiana

    • IU Health West Hospital, Avon, Indiana, 46123
    • Indiana University Medical Center, Indianapolis, Indiana, 46202
    • IU Health Methodist Hospital, Indianapolis, Indiana, 46202
    • Community Regional Cancer Care-East Radiation Oncology, Indianapolis, Indiana, 46219
    • Community Regional Cancer Care-North, Indianapolis, Indiana, 46256
    • IU Health Goshen Center for Cancer Care, Goshen, Indiana, 46526
    • Saint Vincent Anderson Regional Hospital/Cancer Center, Anderson, Indiana, 46016
    • IU Health Ball Memorial Hospital, Muncie, Indiana, 47303
  • Florida

    • 21st Century Oncology - Fort Walton Beach, Fort Walton Beach, Florida, 32547
  • Ohio

    • The Christ Hospital, Cincinnati, Ohio, 45219
  • Georgia

    • Northside Hospital, Atlanta, Georgia, 30342
  • Israel

    • Chaim Sheba Medical Center, Tel Hashomer, 52621
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