Radiation Therapy With or Without Cisplatin in Treating Patients With Recurrent Endometrial Cancer
Endometrial Endometrioid Adenocarcinoma, Variant With Squamous Differentiation, Endometrial Mucinous Adenocarcinoma, Endometrial Squamous Cell Carcinoma
About this trial
This is an interventional treatment trial for Endometrial Endometrioid Adenocarcinoma, Variant With Squamous Differentiation
Eligibility Criteria
Inclusion Criteria:
- All patients must have undergone complete hysterectomy and bilateral salpingo-oophorectomy at the time of original therapy for their uterine carcinoma
- Patients must have a biopsy with histologically confirmed diagnosis of recurrent endometrial cancer confined to the pelvis and/or vagina and no evidence of extrapelvic disease
- Patients must have endometrial carcinoma including endometrioid adenocarcinoma, adenocarcinoma with squamous differentiation, mucinous adenocarcinoma, squamous cell carcinoma, mixed carcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, and serous adenocarcinoma histologies
- Patients must have no evidence of extrapelvic disease; complete workup staging should be performed prior to initiation of therapy to rule-out presence of metastatic disease; this should include: computed tomography (CT) scan of the thorax with IV contrast, as well as a CT of the pelvis and abdomen with IV and oral (PO) contrast performed using multi-detector CT and equal or less than 5 mm slice thickness; if the patient is unable to tolerate contrast, then magnetic resonance imaging (MRI) with IV gadolinium should be performed; a chest x-ray should be done first, and if abnormal, then a CT scan of the chest should be done
Primary surgical debulking before protocol therapy is permissible; this would include removal of gross symptomatic disease in the pelvis and/or vagina
- Exenterative surgery is not permissible; patients with complete resection of gross recurrent disease are eligible
- Patients may have received prior hormone therapy and/or systemic chemotherapy; such therapy must have been completed at least 6 months prior to study entry and the patient has clear evidence of disease subsequent to such therapy; patients must not have received neoadjuvant chemotherapy for the present recurrent disease
- Patients must have Gynecologic Oncology Group (GOG) performance status 0, 1, or 2
- Patients must have an estimated survival greater or equal to 3 months
- Absolute neutrophil count (ANC) >= 1,500/mm^3 , equivalent to Common Toxicity Criteria (Common Terminology Criteria for Adverse Events [CTCAE] version [v] 3.0) grade 1
- Platelets >= 100,000/mm^3 (CTCAE v 3.0 grade 0-1)
- Creatinine =< institutional upper limit normal (ULN), CTCAE v 3.0 grade 0; NOTE: if creatinine > ULN, creatinine clearance must be > 50 mL/min
- Bilirubin =< 1.5 x ULN (CTCAE v 3.0 grade 1)
- Serum glutamic oxaloacetic transaminase (SGOT) =< 2.5 x ULN (CTCAE v 3.0 grade 0-1)
- Alkaline phosphatase =< 2.5 x ULN (CTCAE v 3.0 grade 0-1)
- Neuropathy (sensory and motor) =< CTCAE v 3.0 grade 1
- Patients with ureteral obstruction must undergo stent or nephrostomy tube placement prior to study entry
- Patients who have met the pre-entry requirements
- Patients must have signed an approved informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization
Exclusion Criteria:
- Patients with evidence of disease outside of the pelvis, including presence of positive periaortic or inguino-femoral nodes
- Patients who have received previous vaginal, pelvic, or abdominal irradiation
- Patients who received chemotherapy directed at the present recurrence
- Patients with septicemia or severe infection
- Patients who have circumstances that will not permit completion of this study or the required follow-up
- Patients with renal abnormalities, such as pelvic kidney, horseshoe kidney, or renal transplantation, that would require modification of radiation fields
- 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 five years; patients are also excluded if their previous cancer treatment contraindicates this protocol therapy
- Patients who have undergone complete surgical resection of the recurrent tumor and have no evidence of residual disease evaluable clinically and by CT or MRI imaging, following resection
- Patients who have a significant history of cardiac disease, i.e., uncontrolled hypertension, unstable angina, congestive heart failure, or uncontrolled arrhythmias within 6 months of registration
- Patients with history of active collagen vascular disease
- Patients with GOG performance grade of 3 or 4
Sites / Locations
- Sutter Auburn Faith Hospital
- Sutter Cancer Centers Radiation Oncology Services-Auburn
- Alta Bates Summit Medical Center-Herrick Campus
- Providence Saint Joseph Medical Center/Disney Family Cancer Center
- Mills-Peninsula Medical Center
- Sutter Cancer Centers Radiation Oncology Services-Cameron Park
- Eden Hospital Medical Center
- Sutter Davis Hospital
- UC San Diego Moores Cancer Center
- Loma Linda University Medical Center
- Kaiser Permanente Los Angeles Medical Center
- Memorial Medical Center
- Palo Alto Medical Foundation-Camino Division
- Palo Alto Medical Foundation-Gynecologic Oncology
- Sutter Cancer Research Consortium
- UC Irvine Health/Chao Family Comprehensive Cancer Center
- Palo Alto Medical Foundation Health Care
- Sutter Cancer Centers Radiation Oncology Services-Roseville
- Sutter Roseville Medical Center
- Sutter Medical Center Sacramento
- University of California Davis Comprehensive Cancer Center
- University of California San Diego
- California Pacific Medical Center-Pacific Campus
- Palo Alto Medical Foundation-Santa Cruz
- Sutter Pacific Medical Foundation
- Palo Alto Medical Foundation-Sunnyvale
- Olive View-University of California Los Angeles Medical Center
- Sutter Cancer Centers Radiation Oncology Services-Vacaville
- Sutter Solano Medical Center/Cancer Center
- University of Colorado Hospital
- Hartford Hospital
- Smilow Cancer Hospital Care Center at Saint Francis
- The Hospital of Central Connecticut
- Beebe Medical Center
- Christiana Gynecologic Oncology LLC
- Delaware Clinical and Laboratory Physicians PA
- Helen F Graham Cancer Center
- Medical Oncology Hematology Consultants PA
- Christiana Care Health System-Christiana Hospital
- Beebe Health Campus
- TidalHealth Nanticoke / Allen Cancer Center
- Christiana Care Health System-Wilmington Hospital
- Sibley Memorial Hospital
- Sarasota Memorial Hospital
- Northside Hospital
- Augusta University Medical Center
- Northeast Georgia Medical Center-Gainesville
- Memorial Health University Medical Center
- Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
- Saint Alphonsus Cancer Care Center-Boise
- Saint Alphonsus Cancer Care Center-Caldwell
- Kootenai Health - Coeur d'Alene
- Walter Knox Memorial Hospital
- Idaho Urologic Institute-Meridian
- Saint Alphonsus Medical Center-Nampa
- Kootenai Clinic Cancer Services - Post Falls
- Kootenai Cancer Clinic
- Rush - Copley Medical Center
- Saint Joseph Medical Center
- Illinois CancerCare-Bloomington
- Illinois CancerCare-Canton
- Illinois CancerCare-Carthage
- Northwestern University
- Rush University Medical Center
- University of Chicago Comprehensive Cancer Center
- Illinois CancerCare-Eureka
- NorthShore University HealthSystem-Evanston Hospital
- Illinois CancerCare-Galesburg
- Western Illinois Cancer Treatment Center
- Northwestern Medicine Cancer Center Delnor
- Sudarshan K Sharma MD Limited-Gynecologic Oncology
- Duly Health and Care Joliet
- Illinois CancerCare-Kewanee Clinic
- Illinois CancerCare-Macomb
- Loyola University Medical Center
- Garneau, Stewart C MD (UIA Investigator)
- Spector, David MD (UIA Investigator)
- Trinity Medical Center
- Illinois CancerCare-Monmouth
- Bromenn Regional Medical Center
- Carle Cancer Institute Normal
- Advocate Christ Medical Center
- Illinois CancerCare-Ottawa Clinic
- Ottawa Regional Hospital and Healthcare Center
- Illinois CancerCare-Pekin
- OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center
- Illinois CancerCare-Peoria
- OSF Saint Francis Radiation Oncology at Peoria Cancer Center
- Methodist Medical Center of Illinois
- OSF Saint Francis Medical Center
- Illinois CancerCare-Peru
- Valley Radiation Oncology
- Illinois CancerCare-Princeton
- Northwestern Medicine Cancer Center Warrenville
- Parkview Hospital Randallia
- Parkview Regional Medical Center
- Indiana University/Melvin and Bren Simon Cancer Center
- Franciscan Saint Anthony Health-Michigan City
- Memorial Regional Cancer Center Day Road
- Memorial Hospital of South Bend
- Constantinou, Costas L MD (UIA Investigator)
- Mercy Hospital
- Oncology Associates at Mercy Medical Center
- Medical Oncology and Hematology Associates-West Des Moines
- Mercy Cancer Center-West Lakes
- Iowa Methodist Medical Center
- 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
- Siouxland Regional Cancer Center
- Mercy Medical Center-Sioux City
- Saint Luke's Regional Medical Center
- Methodist West Hospital
- Mercy Medical Center-West Lakes
- Cancer Center of Kansas - Chanute
- Cancer Center of Kansas - Dodge City
- Cancer Center of Kansas - El Dorado
- Cancer Center of Kansas - Fort Scott
- Central Care Cancer Center - Garden City
- Central Care Cancer Center - Great Bend
- Cancer Center of Kansas-Independence
- Providence Medical Center
- Cancer Center of Kansas-Kingman
- Lawrence Memorial Hospital
- Kansas Institute of Medicine Cancer and Blood Center
- Minimally Invasive Surgery Hospital
- Cancer Center of Kansas-Liberal
- Cancer Center of Kansas-Manhattan
- Cancer Center of Kansas - McPherson
- Cancer Center of Kansas - Newton
- Menorah Medical Center
- Saint Luke's South Hospital
- Cancer Center of Kansas - Parsons
- 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
- Ascension Via Christi Hospitals Wichita
- Cancer Center of Kansas - Wichita
- Wesley Medical Center
- Cancer Center of Kansas - Winfield
- Saint Elizabeth Medical Center South
- University of Kentucky/Markey Cancer Center
- Woman's Hospital
- Maine Medical Center-Bramhall Campus
- Maine Medical Center- Scarborough Campus
- Greater Baltimore Medical Center
- Sinai Hospital of Baltimore
- Christiana Care - Union Hospital
- Lahey Hospital and Medical Center
- Baystate Medical Center
- UMass Memorial Medical Center - Memorial Division
- UMass Memorial Medical Center - University Campus
- Bixby Medical Center
- Hickman Cancer Center
- Saint Joseph Mercy Hospital
- McLaren Cancer Institute-Bay City
- IHA Hematology Oncology Consultants-Brighton
- Saint Joseph Mercy Brighton
- IHA Hematology Oncology Consultants-Canton
- Saint Joseph Mercy Canton
- Caro Cancer Center
- IHA Hematology Oncology Consultants-Chelsea
- Saint Joseph Mercy Chelsea
- Hematology Oncology Consultants-Clarkston
- Newland Medical Associates-Clarkston
- Beaumont Hospital - Dearborn
- Wayne State University/Karmanos Cancer Institute
- Ascension Saint John Hospital
- Great Lakes Cancer Management Specialists-Doctors Park
- Weisberg Cancer Treatment Center
- Genesee Cancer and Blood Disease Treatment Center
- Genesee Hematology Oncology PC
- Genesys Hurley Cancer Institute
- Hurley Medical Center
- Genesys Regional Medical Center-West Flint Campus
- McLaren Cancer Institute-Flint
- Singh and Arora Hematology Oncology PC
- Genesys Regional Medical Center
- Academic Hematology Oncology Specialists
- Great Lakes Cancer Management Specialists-Van Elslander Cancer Center
- Michigan Breast Specialists-Grosse Pointe Woods
- Allegiance Health
- Bronson Methodist Hospital
- West Michigan Cancer Center
- Borgess Medical Center
- Sparrow Hospital
- McLaren Cancer Institute-Lapeer Region
- Hope Cancer Clinic
- Saint Mary Mercy Hospital
- Great Lakes Cancer Management Specialists-Macomb Medical Campus
- Michigan Breast Specialists-Macomb Township
- Saint Mary's Oncology/Hematology Associates of Marlette
- Toledo Clinic Cancer Centers-Monroe
- 21st Century Oncology-Pontiac
- Hope Cancer Center
- Newland Medical Associates-Pontiac
- Saint Joseph Mercy Oakland
- Lake Huron Medical Center
- Great Lakes Cancer Management Specialists-Rochester Hills
- Ascension Saint Mary's Hospital
- Oncology Hematology Associates of Saginaw Valley PC
- Bhadresh Nayak MD PC-Sterling Heights
- Advanced Breast Care Center PLLC
- Great Lakes Cancer Management Specialists-Macomb Professional Building
- Macomb Hematology Oncology PC
- Michigan Breast Specialists-Warren
- Saint John Macomb-Oakland Hospital
- Saint Mary's Oncology/Hematology Associates of West Branch
- Huron Gastroenterology PC
- IHA Hematology Oncology Consultants-Ann Arbor
- 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
- Health Partners Inc
- New Ulm Medical Center
- North Memorial Medical Health Center
- Park Nicollet Clinic - Saint Louis Park
- 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
- Central Care Cancer Center - Bolivar
- University of Missouri - Ellis Fischel
- Centerpoint Medical Center LLC
- Freeman Health System
- Saint Luke's Hospital of Kansas City
- Heartland Hematology and Oncology Associates Incorporated
- Research Medical Center
- 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
- Barnes-Jewish Hospital
- Washington University School of Medicine
- Mercy Hospital Springfield
- CoxHealth South Hospital
- Community Hospital of Anaconda
- Billings Clinic Cancer Center
- Saint Vincent Healthcare
- Bozeman Deaconess Hospital
- Saint James Community Hospital and Cancer Treatment Center
- Benefis Healthcare- Sletten Cancer Institute
- Great Falls Clinic
- Saint Peter's Community Hospital
- Kalispell Regional Medical Center
- Saint Patrick Hospital - Community Hospital
- Community Medical Hospital
- Nebraska Methodist Hospital
- Cancer and Blood Specialists-Henderson
- Comprehensive Cancer Centers of Nevada - Henderson
- Las Vegas Cancer Center-Henderson
- 21st Century Oncology-Henderson
- Comprehensive Cancer Centers of Nevada-Southeast Henderson
- University Medical Center of Southern Nevada
- Cancer and Blood Specialists-Shadow
- Radiation Oncology Centers of Nevada Central
- 21st Century Oncology
- HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway
- HealthCare Partners Medical Group Oncology/Hematology-San Martin
- Radiation Oncology Centers of Nevada Southeast
- Cancer Therapy and Integrative Medicine
- 21st Century Oncology-Vegas Tenaya
- Cancer and Blood Specialists-Tenaya
- Comprehensive Cancer Centers of Nevada - Northwest
- HealthCare Partners Medical Group Oncology/Hematology-Tenaya
- Comprehensive Cancer Centers of Nevada-Summerlin
- Las Vegas Cancer Center-Medical Center
- 21st Century Oncology-Fort Apache
- Comprehensive Cancer Centers of Nevada
- OptumCare Cancer Care at Fort Apache
- HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills
- Comprehensive Cancer Centers of Nevada - Central Valley
- Women's Cancer Center of Nevada
- Wentworth-Douglass Hospital
- Dartmouth Hitchcock Medical Center
- Elliot Hospital
- Cooper Hospital University Medical Center
- Virtua Memorial
- Jersey Shore Medical Center
- Rutgers New Jersey Medical School
- The Valley Hospital-Luckow Pavilion
- Valley Hospital
- Community Medical Center
- MD Anderson Cancer Center at Cooper-Voorhees
- Virtua Voorhees
- Valley Health System-Hematology/Oncology
- University of New Mexico Cancer Center
- Southwest Gynecologic Oncology Associates Inc
- State University of New York Downstate Medical Center
- Northwell Health/Center for Advanced Medicine
- North Shore University Hospital
- Long Island Jewish Medical Center
- Highland Hospital
- University of Rochester
- Stony Brook University Medical Center
- State University of New York Upstate Medical University
- Novant Health Presbyterian Medical Center
- Southeastern Medical Oncology Center-Clinton
- Southeastern Medical Oncology Center-Goldsboro
- Wayne Memorial Hospital
- Novant Health Presbyterian Medical Center Huntersville
- Southeastern Medical Oncology Center-Jacksonville
- Wake Forest University Health Sciences
- Summa Health System - Akron Campus
- UHHS-Chagrin Highlands Medical Center
- Strecker Cancer Center-Belpre
- Aultman Health Foundation
- Miami Valley Hospital South
- Adena Regional Medical Center
- University of Cincinnati Cancer Center-UC Medical Center
- Good Samaritan Hospital - Cincinnati
- Bethesda North Hospital
- Case Western Reserve University
- Cleveland Clinic Cancer Center/Fairview Hospital
- Cleveland Clinic Foundation
- Ohio State University Comprehensive Cancer Center
- Mount Carmel East Hospital
- Columbus Oncology and Hematology Associates Inc
- Riverside Methodist Hospital
- Grant Medical Center
- The Mark H Zangmeister Center
- Mount Carmel Health Center West
- Doctors Hospital
- Grandview Hospital
- Delaware Health Center-Grady Cancer Center
- Delaware Radiation Oncology
- Grady Memorial Hospital
- Dublin Methodist Hospital
- Mount Carmel Grove City Hospital
- Kettering Medical Center
- Fairfield Medical Center
- Lancaster Radiation Oncology
- OhioHealth Mansfield Hospital
- Marietta Memorial Hospital
- OhioHealth Marion General Hospital
- Toledo Clinic Cancer Centers-Maumee
- Toledo Radiation Oncology at Northwest Ohio Onocolgy Center
- Hillcrest Hospital Cancer Center
- UH Seidman Cancer Center at Landerbrook Health Center
- UH Seidman Cancer Center at Lake Health Mentor Campus
- Knox Community Hospital
- Licking Memorial Hospital
- Newark Radiation Oncology
- Saint Charles Hospital
- Southern Ohio Medical Center
- Springfield Regional Medical Center
- ProMedica Flower Hospital
- ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital
- University of Toledo
- Toledo Community Hospital Oncology Program CCOP
- Mercy Health - Saint Anne Hospital
- Toledo Clinic Cancer Centers-Toledo
- University Hospitals Sharon Health Center
- University of Cincinnati Cancer Center-West Chester
- Saint Ann's Hospital
- UHHS-Westlake Medical Center
- Genesis Healthcare System Cancer Care Center
- University of Oklahoma Health Sciences Center
- Oklahoma Cancer Specialists and Research Institute-Tulsa
- Saint Alphonsus Medical Center-Baker City
- Legacy Mount Hood Medical Center
- Saint Alphonsus Medical Center-Ontario
- Legacy Good Samaritan Hospital and Medical Center
- Providence Portland Medical Center
- Legacy Meridian Park Hospital
- Jefferson Abington Hospital
- Lehigh Valley Hospital-Cedar Crest
- Saint Luke's University Hospital-Bethlehem Campus
- Lehigh Valley Hospital - Muhlenberg
- Bryn Mawr Hospital
- Geisinger Medical Center
- Delaware County Memorial Hospital
- Pocono Medical Center
- Adams Cancer Center
- Cherry Tree Cancer Center
- Geisinger Medical Oncology-Lewisburg
- Lewistown Hospital
- Paoli Memorial Hospital
- Fox Chase Cancer Center
- Reading Hospital
- Geisinger Wyoming Valley/Henry Cancer Center
- Lankenau Medical Center
- WellSpan Health-York Cancer Center
- WellSpan Health-York Hospital
- Prisma Health Cancer Institute - Spartanburg
- Prisma Health Cancer Institute - Easley
- Greenville Health System Cancer Institute-Andrews
- Prisma Health Cancer Institute - Butternut
- Prisma Health Cancer Institute - Faris
- Prisma Health Greenville Memorial Hospital
- Prisma Health Cancer Institute - Eastside
- Prisma Health Cancer Institute - Greer
- Prisma Health Cancer Institute - Seneca
- Spartanburg Medical Center
- Avera Cancer Institute
- Chattanooga Gynecological Oncology
- University of Tennessee - Knoxville
- Parkland Memorial Hospital
- UT Southwestern/Simmons Cancer Center-Dallas
- Houston Methodist Hospital
- M D Anderson Cancer Center
- Memorial Hermann Texas Medical Center
- Methodist Willowbrook Hospital
- Houston Methodist Sugar Land Hospital
- Huntsman Cancer Institute/University of Utah
- South Jordan Health Center
- University of Vermont Medical Center
- University of Vermont and State Agricultural College
- Legacy Salmon Creek Hospital
- West Virginia University Healthcare
- Green Bay Oncology at Saint Vincent Hospital
- Saint Vincent Hospital Cancer Center Green Bay
- Green Bay Oncology Limited at Saint Mary's Hospital
- Saint Vincent Hospital Cancer Center at Saint Mary's
- Gundersen Lutheran Medical Center
- University of Wisconsin Hospital and Clinics
- Aurora Saint Luke's Medical Center
- Cancer Center of Western Wisconsin
- Aurora West Allis Medical Center
- Rocky Mountain Oncology
- Big Horn Basin Cancer Center
- Billings Clinic-Cody
- Welch Cancer Center
- CHUM - Hopital Notre-Dame
- CHUM - Centre Hospitalier de l'Universite de Montreal
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Arm I (brachytherapy, radiation therapy)
Arm II (brachytherapy, radiation therapy, cisplatin)
Patients undergo EBRT to the pelvis daily on days 1-5 for 5 weeks. After completion of EBRT, patients undergo intracavitary low-dose rate or high-dose rate brachytherapy or low-dose rate interstitial brachytherapy.
Patients undergo EBRT as in Arm I and receive cisplatin IV over 1-2 hours on days 1, 8, 15, 22, and 29. Patients then undergo brachytherapy as in Arm I.