Pelvic Radiation Therapy or Vaginal Implant Radiation Therapy, Paclitaxel, and Carboplatin in Treating Patients With High-Risk Stage I or Stage II Endometrial Cancer
Endometrial Clear Cell Adenocarcinoma, Endometrial Serous Adenocarcinoma, Fatigue
About this trial
This is an interventional treatment trial for Endometrial Clear Cell Adenocarcinoma
Eligibility Criteria
Inclusion Criteria:
- To be considered eligible to participate in this trial, all patients must have undergone hysterectomy; bilateral salpingo-oophorectomy (open or laparoscopic approach) is strongly encouraged
Peritoneal cytology should be obtained on entering the peritoneal cavity, as described in the Gynecologic Oncology Group (GOG) Surgical Procedures Manual (https://gogmember.gog.org/manuals/pdf/surgman.pdf); pelvic and para-aortic lymphadenectomy are optional, but strongly encouraged (as staged patients enrolled on GOG-0210-molecular markers in endometrial carcinoma are eligible for this study)
- The procedures may be performed via laparotomy or laparoscopy (including robot-assisted) as per the surgeon?s preference; the surgeon must record in the operative report whether a lymphadenectomy was performed (see link above to Surgical Procedures Manual) or not; a specific number of lymph nodes removed will not be utilized for eligibility, but the operative report should reflect that the procedure performed was consistent with the procedures described in the GOG Surgical Manual
- If either a bilateral salpingo-oophorectomy or nodal dissection was not performed, post-operative pre-treatment computed tomography (CT)/magnetic resonance imaging (MRI) is required and must not demonstrate evidence suggestive of metastatic disease (adnexa, nodes, intraperitoneal disease); post-operative, pre-treatment CT/MRI must be performed if a pelvic and para-aortic nodal dissection was not performed
For the purposes of description, patients will be staged according to the International Federation of Gynecology and Obstetrics (FIGO) 2009 staging system; eligibility is defined based on clinical-pathologic features; patients with endometrial carcinoma (endometrioid types) confined to the corpus uteri or with endocervical glandular involvement fitting one of the following high-intermediate risk factor categories:
- Age >= 70 years with one risk factor
- Age >= 50 with 2 risk factors
- Age >= 18 years with 3 risk factors
- Risk factors: grade 2 or 3 tumor, (+) lymphovascular space invasion, outer ? myometrial invasion; patients with these risk criteria may be enrolled with either positive or negative cytology
- Patients with stage II endometrial carcinoma (any histology) with cervical stromal invasion (occult or gross involvement), with or without high-intermediate risk factors
- Patients with serous or clear cell histology (with or without other high-intermediate risk factors) are eligible provided the disease is uterine-confined (with or without cervical stromal invasion or endocervical glandular involvement), and with peritoneal cytology negative for malignancy
- Patients must have GOG performance status 0, 1, or 2
- Absolute neutrophil count (ANC) >= 1,500/mcl (equivalent to Common Toxicity Criteria [CTCAE version [v] 3.0] grade 1)
- Platelets >= 100,000/mcl (CTCAE v3.0 grade 0-1)
Serum creatinine =< institutional upper limit normal (ULN), CTCAE v 3.0 grade 0
- Note: If serum creatinine > ULN, a 24-hour creatinine clearance must be collected and must be > 50 mL/min
- Bilirubin =< 1.5 x ULN (CTCAE v3.0 grade 1)
- Serum glutamic oxaloacetic transaminase (SGOT) =< 2.5 x ULN (CTCAE grade 0-1)
- Alkaline phosphatase =< 2.5 x ULN (CTCAE grade 0-1)
- Neuropathy (sensory and motor) =< CTCAE v3.0 grade 1
- Patients who have met the pre-entry requirements; testing values/results must meet eligibility criteria
- Patients must have signed an approved informed consent and authorization permitting release of personal health information
Exclusion Criteria:
- Patients who have already received non-surgical therapy for endometrial cancer including chemotherapy, radiation (example, pre-operative or post-operative brachytherapy), hormonal or biologic therapy
- Patients identified with pathologically confirmed spread of cancer beyond the uterus and cervix to pelvic or para-aortic lymph nodes, adnexal structures, and/or other anatomic sites, or patients with serous or clear cell histology and with positive cytologic washings
- Patients with nodal (for patients who did not have nodal dissection performed) or distant disease determined based on imaging studies; patients with suspicious nodes that have been biopsied (re-staging operation, fine needle aspiration [FNA]) and are pathologically negative will be eligible
- Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer, are excluded if there is any evidence of other malignancy being present within the last 5 years; patients are excluded if their previous cancer treatment contraindicates this protocol therapy; specifically, patients who have received prior radiotherapy directed to treat disease within the abdominal cavity or pelvis are excluded
- Prior radiation of localized cancer of the breast, head and neck, thyroid, or skin is permitted, provided that it was completed more than 5 years prior to registration, and the patient remains free of recurrent or metastatic disease
- Patients may have received prior adjuvant chemotherapy for localized breast cancer, provided that it was completed more than 5 years prior to registration, and the patient remains free of recurrent or metastatic disease
- Patients who have contraindications to pelvic radiation therapy (RT) (e.g. pelvic kidney, connective tissue disease, inflammatory bowel disease, etc.) should be screened in advance and not be considered eligible for the trial
- Patients with recurrent endometrial cancer
- Patients with surgical or clinical, FIGO 2009 stage III or IV endometrial carcinoma
- Patients with non-epithelial uterine malignancies such as uterine carcinosarcoma or leiomyosarcoma
Sites / Locations
- University of Alabama at Birmingham Cancer Center
- University of South Alabama Mitchell Cancer Institute
- Providence Alaska Medical Center
- Saint Joseph's Hospital and Medical Center
- Arizona Oncology Associates-West Orange Grove
- University of Arizona Cancer Center-North Campus
- Sutter Cancer Centers Radiation Oncology Services-Auburn
- Providence Saint Joseph Medical Center/Disney Family Cancer Center
- Sutter Cancer Centers Radiation Oncology Services-Cameron Park
- Mercy San Juan Medical Center
- John Muir Medical Center-Concord Campus
- UC San Diego Moores Cancer Center
- Long Beach Memorial Medical Center-Todd Cancer Institute
- Kaiser Permanente Los Angeles Medical Center
- Cedars Sinai Medical Center
- UCLA / Jonsson Comprehensive Cancer Center
- Memorial Medical Center
- Palo Alto Medical Foundation-Gynecologic Oncology
- Kaiser Permanente Oakland-Broadway
- Kaiser Permanente-Oakland
- Saint Joseph Hospital - Orange
- UC Irvine Health/Chao Family Comprehensive Cancer Center
- Stanford Cancer Institute Palo Alto
- Kaiser Permanente-Redwood City
- Kaiser Permanente-Richmond
- Rohnert Park Cancer Center
- Kaiser Permanente-Roseville
- Sutter Cancer Centers Radiation Oncology Services-Roseville
- Sutter Roseville Medical Center
- Sutter Medical Center Sacramento
- University of California Davis Comprehensive Cancer Center
- Mercy General Hospital Radiation Oncology Center
- Kaiser Permanente-South Sacramento
- Kaiser Permanente - Sacramento
- University of California San Diego
- Kaiser Permanente-San Francisco
- UCSF Medical Center-Mount Zion
- Kaiser Permanente-Santa Teresa-San Jose
- Kaiser Permanente San Leandro
- Kaiser Permanente-San Rafael
- Kaiser Permanente Medical Center - Santa Clara
- Kaiser Permanente-Santa Rosa
- Kaiser Permanente-South San Francisco
- Kaiser Permanente-Stockton
- Olive View-University of California Los Angeles Medical Center
- Sutter Cancer Centers Radiation Oncology Services-Vacaville
- Kaiser Permanente-Vallejo
- Kaiser Permanente-Walnut Creek
- John Muir Medical Center-Walnut Creek
- Colorado Gynecologic Oncology Group
- Rocky Mountain Cancer Centers-Aurora
- The Medical Center of Aurora
- University of Colorado Hospital
- Boulder Community Hospital
- Penrose-Saint Francis Healthcare
- Porter Adventist Hospital
- Presbyterian - Saint Lukes Medical Center - Health One
- SCL Health Saint Joseph Hospital
- Rose Medical Center
- Colorado Cancer Research Program NCORP
- Swedish Medical Center
- Saint Mary's Hospital and Regional Medical Center
- North Colorado Medical Center
- Saint Anthony Hospital
- Rocky Mountain Cancer Centers-Littleton
- Littleton Adventist Hospital
- Sky Ridge Medical Center
- Longmont United Hospital
- McKee Medical Center
- Parker Adventist Hospital
- Saint Mary Corwin Medical Center
- North Suburban Medical Center
- SCL Health Lutheran Medical Center
- Saint Vincent's Medical Center
- Danbury Hospital
- University of Connecticut
- Hartford Hospital
- The Hospital of Central Connecticut
- Yale University
- Eastern Connecticut Hematology and Oncology Associates
- William Backus Hospital
- Beebe Medical Center
- Christiana Care Health System-Christiana Hospital
- MedStar Washington Hospital Center
- Sibley Memorial Hospital
- Morton Plant Hospital
- Holy Cross Hospital
- Florida Gynecologic Oncology
- Southeast Gynecologic Oncology Associates
- University of Miami Miller School of Medicine-Sylvester Cancer Center
- Florida Hospital Orlando
- Florida Institute of Research Medicine and Surgery-Cancer Center
- UF Cancer Center at Orlando Health
- Women's Cancer Associates
- Grady Health System
- Emory University Hospital Midtown
- Emory University Hospital/Winship Cancer Institute
- Northside Hospital
- Augusta University Medical Center
- John B Amos Cancer Center
- Northeast Georgia Medical Center-Gainesville
- Central Georgia Gynecologic Oncology
- Memorial Health University Medical Center
- Pali Momi Medical Center
- The Cancer Center of Hawaii-Pali Momi
- Hawaii Cancer Care Inc-POB II
- Queen's Medical Center
- Straub Clinic and Hospital
- University of Hawaii Cancer Center
- Hawaii Oncology Inc-Kuakini
- The Cancer Center of Hawaii-Liliha
- Kapiolani Medical Center for Women and Children
- Wilcox Memorial Hospital and Kauai Medical Clinic
- Maui Memorial Medical Center
- Saint Luke's Mountain States Tumor Institute
- Saint Luke's Mountain States Tumor Institute - Fruitland
- Saint Luke's Mountain States Tumor Institute - Meridian
- Saint Luke's Mountain States Tumor Institute - Nampa
- Saint Luke's Mountain States Tumor Institute-Twin Falls
- Saint Anthony's Health
- Saint Joseph Medical Center
- Northwestern University
- John H Stroger Jr Hospital of Cook County
- Rush University Medical Center
- University of Illinois
- University of Chicago Comprehensive Cancer Center
- Heartland Cancer Research NCORP
- NorthShore University HealthSystem-Evanston Hospital
- Western Illinois Cancer Treatment Center
- Hinsdale Hematology Oncology Associates Incorporated
- Sudarshan K Sharma MD Limited-Gynecologic Oncology
- Loyola University Medical Center
- Good Samaritan Regional Health Center
- Bromenn Regional Medical Center
- Community Cancer Center Foundation
- Advocate Christ Medical Center
- Illinois CancerCare-Ottawa Clinic
- Ottawa Regional Hospital and Healthcare Center
- Advocate Lutheran General Hospital
- Illinois CancerCare-Peoria
- OSF Saint Francis Radiation Oncology at Peoria Cancer Center
- OSF Saint Francis Medical Center
- Valley Radiation Oncology
- Swedish American Hospital
- Memorial Medical Center
- Northwestern Medicine Cancer Center Warrenville
- Northwestern Medicine Central DuPage Hospital
- Franciscan Saint Francis Health-Beech Grove
- Franciscan Saint Margaret Health-Dyer Campus
- Elkhart Clinic
- Michiana Hematology Oncology PC-Elkhart
- Elkhart General Hospital
- Radiation Oncology Associates PC
- Parkview Hospital Randallia
- Franciscan Saint Margaret Health-Hammond Campus
- Indiana University/Melvin and Bren Simon Cancer Center
- IU Health Central Indiana Cancer Centers-East
- Franciscan Health Indianapolis
- Saint Vincent Hospital and Health Care Center
- Community Howard Regional Health
- IU Health La Porte Hospital
- Michiana Hematology Oncology PC-Mishawaka
- Saint Joseph Regional Medical Center-Mishawaka
- The Community Hospital
- Michiana Hematology Oncology PC-Plymouth
- Reid Health
- Memorial Hospital of South Bend
- Michiana Hematology Oncology PC-South Bend
- South Bend Clinic
- Northern Indiana Cancer Research Consortium
- Michiana Hematology Oncology PC-Westville
- McFarland Clinic PC - Ames
- Medical Oncology and Hematology Associates-West Des Moines
- Iowa Methodist Medical Center
- Iowa-Wide Oncology Research Coalition NCORP
- Medical Oncology and Hematology Associates-Des Moines
- Medical Oncology and Hematology Associates-Laurel
- Mercy Medical Center - Des Moines
- Iowa Lutheran Hospital
- University of Iowa/Holden Comprehensive Cancer Center
- Mercy Medical Center - North Iowa
- Hospital District Sixth of Harper County
- Cancer Center of Kansas - Chanute
- Cancer Center of Kansas - Dodge City
- Cancer Center of Kansas - El Dorado
- Cancer Center of Kansas - Fort Scott
- Cancer Center of Kansas-Independence
- University of Kansas Cancer Center
- Cancer Center of Kansas-Kingman
- Lawrence Memorial Hospital
- Southwest Medical Center
- Cancer Center of Kansas-Liberal
- Cancer Center of Kansas - Newton
- Menorah Medical Center
- Saint Luke's South Hospital
- Cancer Center of Kansas - Parsons
- Kansas City NCI Community Oncology Research Program
- Cancer Center of Kansas - Pratt
- Cancer Center of Kansas - Salina
- Cancer Center of Kansas - Wellington
- Associates In Womens Health
- Cancer Center of Kansas-Wichita Medical Arts Tower
- Cancer Center of Kansas - Wichita
- Via Christi Regional Medical Center
- Wesley Medical Center
- Wichita NCI Community Oncology Research Program
- Cancer Center of Kansas - Winfield
- Saint Elizabeth Medical Center South
- Baptist Health Lexington
- University of Kentucky/Markey Cancer Center
- The James Graham Brown Cancer Center at University of Louisville
- Pikeville Medical Center
- Woman's Hospital
- Louisiana State University Health Science Center
- University Medical Center New Orleans
- Ochsner Medical Center Jefferson
- Louisiana State University Health Sciences Center Shreveport
- Maine Medical Center-Bramhall Campus
- University of Maryland/Greenebaum Cancer Center
- Greater Baltimore Medical Center
- Sinai Hospital of Baltimore
- Saint Agnes Hospital
- MedStar Franklin Square Medical Center/Weinberg Cancer Institute
- Walter Reed National Military Medical Center
- Union Hospital of Cecil County
- Tufts Medical Center
- Lahey Hospital and Medical Center
- University of Massachusetts Memorial Health Care
- University of Massachusetts Medical School
- Bronson Battle Creek
- Spectrum Health Big Rapids Hospital
- Wayne State University/Karmanos Cancer Institute
- Henry Ford Hospital
- Cancer Research Consortium of West Michigan NCORP
- Mercy Health Saint Mary's
- Spectrum Health at Butterworth Campus
- Bronson Methodist Hospital
- West Michigan Cancer Center
- Borgess Medical Center
- Mercy Health Mercy Campus
- Lakeland Hospital Niles
- Spectrum Health Reed City Hospital
- William Beaumont Hospital-Royal Oak
- Lakeland Medical Center Saint Joseph
- Marie Yeager Cancer Center
- Munson Medical Center
- Sanford Joe Lueken Cancer Center
- Fairview Ridges Hospital
- Mercy Hospital
- Fairview-Southdale Hospital
- Unity Hospital
- Hutchinson Area Health Care
- Minnesota Oncology Hematology PA-Maplewood
- Saint John's Hospital - Healtheast
- Abbott-Northwestern Hospital
- Hennepin County Medical Center
- University of Minnesota/Masonic Cancer Center
- New Ulm Medical Center
- North Memorial Medical Health Center
- Metro Minnesota Community Oncology Research Consortium
- Park Nicollet Clinic - Saint Louis Park
- Park Nicollet Frauenshuh Cancer Center
- Regions Hospital
- United Hospital
- Saint Francis Regional Medical Center
- Lakeview Hospital
- Ridgeview Medical Center
- Rice Memorial Hospital
- Minnesota Oncology Hematology PA-Woodbury
- University of Mississippi Medical Center
- Singing River Hospital
- Saint Francis Medical Center
- University of Missouri - Ellis Fischel
- Truman Medical Center
- Saint Luke's Hospital of Kansas City
- Saint Joseph Health Center
- North Kansas City Hospital
- Heartland Hematology and Oncology Associates Incorporated
- Research Medical Center
- The University of Kansas Cancer Center-North
- Saint Luke's East - Lee's Summit
- Liberty Radiation Oncology Center
- Mercy Clinic-Rolla-Cancer and Hematology
- Heartland Regional Medical Center
- Saint Joseph Oncology Inc
- Washington University School of Medicine
- Mercy Hospital Saint Louis
- Saint Louis-Cape Girardeau CCOP
- Cancer Research for the Ozarks NCORP
- Mercy Hospital Springfield
- CoxHealth South Hospital
- Billings Clinic Cancer Center
- Northern Rockies Radiation Oncology Center
- Montana Cancer Consortium NCORP
- Benefis Healthcare- Sletten Cancer Institute
- Berdeaux, Donald MD (UIA Investigator)
- Great Falls Clinic
- Nebraska Methodist Hospital
- University of Nebraska Medical Center
- Nevada Cancer Research Foundation CCOP
- Women's Cancer Center of Nevada
- Center of Hope at Renown Medical Center
- Renown Regional Medical Center
- Elliot Hospital
- Cooper Hospital University Medical Center
- Hackensack University Medical Center
- Saint Barnabas Medical Center
- Monmouth Medical Center
- Morristown Medical Center
- Virtua Memorial
- Jersey Shore Medical Center
- Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital
- Rutgers Cancer Institute of New Jersey
- Rutgers New Jersey Medical School
- Saint Luke's Hospital-Warren Campus
- Valley Hospital
- Overlook Hospital
- Community Medical Center
- Inspira Medical Center Vineland
- Virtua Voorhees
- University of New Mexico Cancer Center
- Southwest Gynecologic Oncology Associates Inc
- Memorial Medical Center - Las Cruces
- Women's Cancer Care Associates LLC
- Island Gynecologic Oncology
- State University of New York Downstate Medical Center
- Roswell Park Cancer Institute
- Sands Cancer Center
- New York Hospital Medical Center of Queens
- Northwell Health NCORP
- Northwell Health/Center for Advanced Medicine
- North Shore University Hospital
- Orange Regional Medical Center
- NYU Winthrop Hospital
- Long Island Jewish Medical Center
- Mount Sinai Union Square
- Laura and Isaac Perlmutter Cancer Center at NYU Langone
- Mount Sinai West
- Mount Sinai Hospital
- NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
- Memorial Sloan Kettering Cancer Center
- Highland Hospital
- University Radiation Oncology
- University of Rochester
- Stony Brook University Medical Center
- State University of New York Upstate Medical University
- Randolph Hospital
- Hope Women's Cancer Centers-Asheville
- UNC Lineberger Comprehensive Cancer Center
- Carolinas Medical Center/Levine Cancer Institute
- Novant Health Presbyterian Medical Center
- Atrium Health Cabarrus/LCI-Concord
- Duke University Medical Center
- Cone Health Cancer Center
- Duke Women's Cancer Care Raleigh
- Duke Raleigh Hospital
- Annie Penn Memorial Hospital
- Rutherford Hospital
- New Hanover Regional Medical Center/Zimmer Cancer Center
- Southeast Clinical Oncology Research (SCOR) Consortium NCORP
- Wake Forest University Health Sciences
- Roger Maris Cancer Center
- Sanford Broadway Medical Center
- Sanford Clinic North-Fargo
- Summa Akron City Hospital/Cooper Cancer Center
- Cleveland Clinic Akron General
- Summa Barberton Hospital
- Aultman Health Foundation
- Adena Regional Medical Center
- University of Cincinnati/Barrett Cancer Center
- Good Samaritan Hospital - Cincinnati
- Bethesda North Hospital
- Oncology Hematology Care Inc-Blue Ash
- Case Western Reserve University
- Cleveland Clinic Cancer Center/Fairview Hospital
- Cleveland Clinic Foundation
- Ohio State University Comprehensive Cancer Center
- Riverside Methodist Hospital
- Columbus NCI Community Oncology Research Program
- Grant Medical Center
- The Mark H Zangmeister Center
- Mount Carmel Health Center West
- Doctors Hospital
- Good Samaritan Hospital - Dayton
- Miami Valley Hospital
- Miami Valley Hospital North
- Grady Memorial Hospital
- Blanchard Valley Hospital
- Atrium Medical Center-Middletown Regional Hospital
- Kettering Medical Center
- Marietta Memorial Hospital
- Hillcrest Hospital Cancer Center
- UH Seidman Cancer Center at Lake Health Mentor Campus
- Licking Memorial Hospital
- Southern Ohio Medical Center
- UH Seidman Cancer Center at Salem Regional Medical Center
- Springfield Regional Medical Center
- Upper Valley Medical Center
- Saint Ann's Hospital
- Cancer Treatment Center
- Wright-Patterson Medical Center
- Genesis Healthcare System Cancer Care Center
- University of Oklahoma Health Sciences Center
- Oklahoma Cancer Specialists and Research Institute-Tulsa
- Willamette Valley Cancer Center
- Legacy Good Samaritan Hospital and Medical Center
- Compass Oncology Rose Quarter
- Oregon Health and Science University
- Salem Hospital
- Abington Memorial Hospital
- Lehigh Valley Hospital-Cedar Crest
- Saint Luke's University Hospital-Bethlehem Campus
- Bryn Mawr Hospital
- Geisinger Medical Center
- Adams Cancer Center
- Cherry Tree Cancer Center
- Geisinger Medical Center-Cancer Center Hazleton
- Penn State Milton S Hershey Medical Center
- Lancaster General Hospital
- Paoli Memorial Hospital
- University of Pennsylvania/Abramson Cancer Center
- Pennsylvania Hospital
- Thomas Jefferson University Hospital
- Fox Chase Cancer Center
- Temple University Hospital
- UPMC-Magee Womens Hospital
- University of Pittsburgh Cancer Institute (UPCI)
- Geisinger Medical Group
- Reading Hospital
- Geisinger Wyoming Valley/Henry Cancer Center
- Lankenau Medical Center
- Main Line Health NCORP
- WellSpan Health-York Cancer Center
- WellSpan Health-York Hospital
- Women and Infants Hospital
- AnMed Health Cancer Center
- AnMed Health Hospital
- Greenville Health System Cancer Institute-Andrews
- Saint Francis Hospital
- Greenville Health System Cancer Institute-Butternut
- Greenville Health System Cancer Institute-Faris
- Greenville Memorial Hospital
- Greenville Health System Cancer Institute-Eastside
- Greenville Health System Cancer Institute-Greer
- Greenville Health System Cancer Institute-Seneca
- Spartanburg Medical Center
- Greenville Health System Cancer Institute-Spartanburg
- Black Hills Obstetrics and Gynecology
- Sanford Cancer Center Oncology Clinic
- Avera Cancer Institute
- Sanford USD Medical Center - Sioux Falls
- Chattanooga Gynecological Oncology
- Chattanooga's Program in Women's Oncology
- University of Tennessee - Knoxville
- Tennessee Oncology PLLC- Centennial Medical Center
- Meharry Medical College
- Vanderbilt University/Ingram Cancer Center
- Texas Oncology-Arlington South
- Texas Oncology-Austin Midtown
- Texas Oncology - Central Austin Cancer Center
- Texas Oncology - South Austin Cancer Center
- Texas Oncology Bedford
- Baylor University Medical Center
- Clements University Hospital
- UT Southwestern/Simmons Cancer Center-Dallas
- Texas Oncology-Denton South
- Brooke Army Medical Center
- Baylor All Saints Medical Center at Fort Worth
- The Klabzuba Cancer Center
- University of Texas Medical Branch
- Memorial Hermann Memorial City Medical Center
- M D Anderson Cancer Center
- The Methodist Hospital System
- Wilford Hall Medical Center
- Texas Oncology-Longview Cancer Center
- West Texas Cancer Center
- Texas Oncology - Round Rock Cancer Center
- Texas Cancer Center-Sherman
- Texas Oncology Cancer Center Sugar Land
- Tyler Cancer Center
- Texas Oncology-Wichita Falls Texoma Cancer Center
- Sandra L Maxwell Cancer Center
- Intermountain Medical Center
- McKay-Dee Hospital Center
- Utah Valley Regional Medical Center
- Dixie Medical Center Regional Cancer Center
- Intermountain Health Care
- Utah Cancer Specialists-Salt Lake City
- Huntsman Cancer Institute/University of Utah
- LDS Hospital
- University of Vermont Medical Center
- Northern Virginia Pelvic Surgery Associates
- University of Virginia Cancer Center
- Virginia Commonwealth University/Massey Cancer Center
- Carilion Clinic Gynecological Oncology
- PeaceHealth Medical Group PC
- Harrison HealthPartners Hematology and Oncology-Bremerton
- Harrison Medical Center
- Providence Regional Cancer Partnership
- Skagit Valley Hospital Regional Cancer Care Center
- Harrison HealthPartners Hematology and Oncology-Poulsbo
- Virginia Mason Medical Center
- Pacific Gynecology Specialists
- Fred Hutchinson Cancer Research Center
- Seattle Cancer Care Alliance
- Kaiser Permanente Washington
- Swedish Medical Center-First Hill
- Northwest Hospital
- University of Washington Medical Center
- Olympic Medical Cancer Care Center
- Cancer Care Northwest - Spokane South
- Rockwood Cancer Treatment Center-DHEC-Downtown
- MultiCare Tacoma General Hospital
- Saint Joseph Medical Center
- Providence Saint Mary Regional Cancer Center
- Wenatchee Valley Hospital and Clinics
- Cancer Institutes of Washington PLLC
- North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
- Wheeling Hospital/Schiffler Cancer Center
- Aurora Cancer Care-Grafton
- Aurora BayCare Medical Center
- Gundersen Lutheran Medical Center
- University of Wisconsin Hospital and Clinics
- Columbia Saint Mary's Hospital - Ozaukee
- Columbia Saint Mary's Water Tower Medical Commons
- Aurora Saint Luke's Medical Center
- Froedtert and the Medical College of Wisconsin
- Aurora Sinai Medical Center
- Vince Lombardi Cancer Clinic - Oshkosh
- Wheaton Franciscan Cancer Care - All Saints
- Aurora Medical Center in Summit
- Vince Lombardi Cancer Clinic-Two Rivers
- Aurora West Allis Medical Center
- Inha University
- Asan Medical Center
- Seoul National University Hospital
- Gangnam Severance Hospital
- Yongdong Severence Hospital
- Korea Cancer Center Hospital
- Ajou University Hospital
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Arm I (pelvic radiation therapy)
Arm II (brachytherapy, paclitaxel, carboplatin)
Patients undergo conventional or intensity-modulated pelvic radiation therapy once daily, 5 days a week, for 5-6 weeks (total of 25-28 fractions) in the absence of disease progression or unacceptable toxicity. Patients with stage II disease or stage I disease with a confirmed diagnosis of clear cell and/or papillary serous histology may also undergo 1 or 2 intravaginal (i.e., vaginal cuff) brachytherapy boost treatments.
Patients undergo vaginal cuff brachytherapy comprising 3-5 high-dose rate brachytherapy treatments over approximately 2 weeks or 1 or 2 low-dose rate brachytherapy treatments over 1-2 days. Beginning within 3 weeks after initiating brachytherapy, patients receive paclitaxel IV over 3 hours and carboplatin IV over 30-60 minutes on day 1. Chemotherapy repeats every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.