A Randomized Trial of Pelvic Irradiation With or Without Concurrent Weekly Cisplatin in Patients With Pelvic-Only Recurrence of Carcinoma of the Uterine Corpus
OBJECTIVES:
Primary
- Determine whether pelvic radiotherapy and cisplatin are more promising with respect to
progression-free survival than pelvic radiotherapy alone in patients with recurrent
endometrial cancer limited to the pelvis and vagina.
Secondary
- Compare the sites of recurrence in patients treated with these regimens.
- Compare overall survival of patients treated with these regimens.
- Compare the prognostic significance of the location (central pelvis versus vagina) and
size of the recurrence, in addition to the prognostic significance in the salvage
setting, in terms of histological subtype, grade, age, race, performance status, and
the presence of lymph-vascular space involvement of the original tumor at the time of
initial hysterectomy, in patients treated with these regimens.
- Compare the toxicity of these regimens in these patients.
OUTLINE: This is a multicenter, randomized study. Patients are randomized to 1 of 2
treatment arms.
- Arm I: Patients undergo external-beam radiotherapy (EBRT) to the pelvis on days 1-5,
8-12, 15-19, 22-26, 29-33, and 36-40. After completion of EBRT, patients undergo
intracavitary low-dose rate or high-dose rate brachytherapy* or low-dose rate
interstitial brachytherapy*.
- Arm II: Patients undergo EBRT as in arm I and receive cisplatin IV over 1-2 hours on
days 1, 8, 15, 22, 29, and 36. Patients then undergo brachytherapy* as in arm I.
NOTE: *IMRT will be allowed for the entire course of therapy, this is for the treatment of
the whole pelvis and/or the boost in those cases not undergoing brachytherapy.
In both arms, treatment continues in the absence of disease progression or unacceptable
toxicity.
After completion of study treatment, patients are followed monthly for 3 months, every 3
months for 2 years, and then every 6 months for 3 years.
Interventional
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Duration of progression-free survival
No
Shu-Yuan Liao, MD
Study Chair
St. Joseph Hospital Health Center
United States: NCI, OHRP
GOG-0238
NCT00492778
February 2008
Name | Location |
---|---|
University of Iowa Hospitals and Clinics | Iowa City, Iowa 52242 |
University of Mississippi Medical Center | Jackson, Mississippi 39216-4505 |
Abington Memorial Hospital | Abington, Pennsylvania 19001 |
Fox Chase Cancer Center | Philadelphia, Pennsylvania 19111 |
Hurley Medical Center | Flint, Michigan 48503 |
Sinai Hospital of Baltimore | Baltimore, Maryland 21225 |
Genesys Hurley Cancer Institute | Flint, Michigan 48503 |
Bronson Methodist Hospital | Kalamazoo, Michigan 49007 |
West Michigan Cancer Center | Kalamazoo, Michigan 49007-3731 |
Borgess Medical Center | Kalamazooaa, Michigan 49001 |
Fairview Ridges Hospital | Burnsville, Minnesota 55337 |
Hutchinson Area Health Care | Hutchinson, Minnesota 55350 |
United Hospital | St. Paul, Minnesota 55102 |
Ridgeview Medical Center | Waconia, Minnesota 55387 |
Avera Cancer Institute | Sioux Falls, South Dakota 57105 |
Community Medical Center | Toms River, New Jersey 08755 |
North Shore University Hospital | Manhasset, New York 11030 |
Hartford Hospital | Hartford, Connecticut 06102-5037 |
Baystate Medical Center | Springfield, Massachusetts 01199 |
Via Christi Regional Medical Center | Wichita, Kansas 67214 |
Wesley Medical Center | Wichita, Kansas 67214 |
University of Oklahoma Health Sciences Center | Oklahoma City, Oklahoma 73104 |
Iowa Methodist Medical Center | Des Moines, Iowa 50309 |
Iowa Lutheran Hospital | Des Moines, Iowa 50316-2301 |
University of Wisconsin Hospital and Clinics | Madison, Wisconsin 53792-0001 |
Great Falls Clinic | Great Falls, Montana 59405 |
Valley Hospital | Ridgewood, New Jersey 07450 |
Long Island Jewish Medical Center | New Hyde Park, New York 11040 |
Advocate Christ Medical Center | Oak Lawn, Illinois 60453 |
Cancer Center of Kansas - Chanute | Chanute, Kansas 66720 |
Cancer Center of Kansas - Dodge City | Dodge City, Kansas 67801 |
Cancer Center of Kansas - Newton | Newton, Kansas 67114 |
Cancer Center of Kansas - Salina | Salina, Kansas 67042 |
Cancer Center of Kansas - Wellington | Wellington, Kansas 67152 |
Associates in Womens Health | Wichita, Kansas 67203 |
Cancer Center of Kansas - Winfield | Winfield, Kansas 67156 |
Adena Regional Medical Center | Chillicothe, Ohio 54601 |
Grady Memorial Hospital | Delaware, Ohio 43015 |
University of New Mexico Cancer Center | Albuquerque, New Mexico 87131-5636 |
Good Samaritan Hospital - Cincinnati | Cincinnati, Ohio 45220 |
Methodist Estabrook Cancer Center | Omaha, Nebraska 68114-4199 |
Paoli Memorial Hospital | Paoli, Pennsylvania 19301-1792 |
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center | Columbus, Ohio 43210-1240 |
Parkland Memorial Hospital | Dallas, Texas 75235 |
Beebe Medical Center | Lewes, Delaware 19958 |
BroMenn Regional Medical Center | Normal, Illinois 61761 |
Valley Cancer Center | Spring Valley, Illinois 61362 |
Bryn Mawr Hospital | Bryn Mawr, Pennsylvania 19010 |
Mercy Hospital | Coon Rapids, Minnesota 55433 |
Saint Joseph Medical Center | Joliet, Illinois 60435 |
Trinity Medical Center | Moline, Illinois 61265-1291 |
Medical Oncology and Hematology Associates | Des Moines, Iowa 50309 |
Saint Joseph Mercy Hospital | Ann Arbor, Michigan 48106 |
Fairview-Southdale Hospital | Edina, Minnesota 55435 |
Abbott-Northwestern Hospital | Minneapolis, Minnesota 55407 |
Regions Hospital | Saint Paul, Minnesota 55101 |
Saint Francis Regional Medical Center | Shakopee, Minnesota 55379 |
Rice Memorial Hospital | Willmar, Minnesota 56201 |
Northeast Georgia Medical Center | Gainesville, Georgia 30501 |
Cancer Center of Kansas - Fort Scott | Fort Scott, Kansas 66701 |
Cancer Center of Kansas-Independence | Independence, Kansas 67301 |
Lawrence Memorial Hospital | Lawrence, Kansas 66044 |
Woman's Hospital | Baton Rouge, Louisiana 70815 |
Genesys Regional Medical Center | Grand Blanc, Michigan 48439-8066 |
Singing River Hospital | Pascagoula, Mississippi 39581 |
Zale Lipshy University Hospital | Dallas, Texas 75235-7786 |
Greater Baltimore Medical Center | Baltimore, Maryland 21204 |
Union Hospital of Cecil County | Elkton MD, Maryland 21921 |
Northwestern University | Chicago, Illinois 60611 |
Memorial Medical Center | Modesto, California 95355 |
Hennepin County Medical Center | Minneapolis, Minnesota |
Saint Alphonsus Regional Medical Center | Boise, Idaho 83706 |
University of California at San Diego | La Jolla, California 92093 |
Case Western Reserve University | Cleveland, Ohio 44106 |
Wayne State University | Detroit, Michigan 48202 |
University of Massachusetts Medical School | Worcester, Massachusetts 01605 |
Riverside Methodist Hospital | Columbus, Ohio 43214 |
Licking Memorial Hospital | Newark, Ohio 43055-2899 |
Columbus CCOP | Columbus, Ohio 43206 |
Indiana University Medical Center | Indianapolis, Indiana 46202 |
University of Texas Southwestern Medical Center | Dallas, Texas |
University of Kentucky | Lexington, Kentucky 40536-0098 |
Wichita CCOP | Wichita, Kansas 67214-3882 |
Montana Cancer Consortium CCOP | Billings, Montana 59101 |
Huntsman Cancer Institute/University of Utah | Salt Lake City, Utah 84112 |
Metro-Minnesota CCOP | St. Louis Park, Minnesota |
UC Davis Comprehensive Cancer Center | Sacramento, California 95817 |
Lakeview Hospital | Stillwater, Minnesota 55082 |
Lankenau Hospital | Wynnewood, Pennsylvania 19096 |
Providence Saint Joseph Medical Center | Burbank, California 91505-4866 |
Memorial Health University Medical Center | Savannah, Georgia 31404 |
University of Chicago Comprehensive Cancer Center | Chicago, Illinois 60637-1470 |
M D Anderson Cancer Center | Houston, Texas 77030 |
University of Cincinnati | Cincinnati, Ohio 45267-0502 |
New Ulm Medical Center | New Ulm, Minnesota 56073 |
Wake Forest University Health Sciences | Winston-Salem, North Carolina 27157 |
OSF Saint Francis Medical Center | Peoria, Illinois 61637 |
Northside Hospital | Atlanta, Georgia 30342 |
Saint Francis Hospital and Medical Center | Hartford, Connecticut 06105 |
The Hospital of Central Connecticut | New Britain, Connecticut 06050 |
Saint Joseph's-Candler Health System | Savannah, Georgia 31405 |
Rush - Copley Medical Center | Aurora, Illinois 60504 |
Evanston CCOP-NorthShore University HealthSystem | Evanston, Illinois 60201 |
Joliet Oncology-Hematology Associates Limited | Joliet, Illinois 60435 |
Community Cancer Center Foundation | Normal, Illinois 61761 |
Illinois CancerCare-Ottawa Clinic | Ottawa, Illinois 61350 |
Ottawa Regional Hospital and Healthcare Center | Ottawa, Illinois 61350 |
Illinois Oncology Research Association CCOP | Peoria, Illinois 61615 |
Illinois CancerCare-Peoria | Peoria, Illinois 61615 |
Carle Clinic-Urbana Main | Urbana, Illinois 61801 |
Saint Anthony Memorial Health Center | Michigan City, Indiana 46360 |
Medical Oncology and Hematology Associates-West Des Moines | Clive, Iowa 50325 |
Iowa Oncology Research Association CCOP | Des Moines, Iowa 50309 |
Mercy Medical Center - Des Moines | Des Moines, Iowa 50314 |
Medical Oncology and Hematology Associates-Des Moines | Des Moines, Iowa 50309 |
Mercy Medical Center-Sioux City | Sioux City, Iowa 51104 |
Saint Luke's Regional Medical Center | Sioux City, Iowa 51104 |
Cancer Center of Kansas - El Dorado | El Dorado, Kansas 67042 |
Cancer Center of Kansas-Kingman | Kingman, Kansas 67068 |
Cancer Center of Kansas - Parsons | Parsons, Kansas 67357 |
Cancer Center of Kansas - Pratt | Pratt, Kansas 67124 |
Cancer Center of Kansas-Wichita Medical Arts Tower | Wichita, Kansas 67208 |
Cancer Center of Kansas - Main Office | Wichita, Kansas 67214 |
Michigan Cancer Research Consortium Community Clinical Oncology Program | Ann Arbor, Michigan 48106 |
Oakwood Hospital | Dearborn, Michigan 48123 |
Saint John Hospital and Medical Center | Detroit, Michigan 48236 |
Allegiance Health | Jackson, Michigan 49201 |
Sparrow Hospital | Lansing, Michigan 48912 |
Saint Mary Mercy Hospital | Livonia, Michigan 48154 |
Saint Joseph Mercy Oakland | Pontiac, Michigan 48341-2985 |
Saint Joseph Mercy Port Huron | Port Huron, Michigan 48060 |
Saint Mary's of Michigan | Saginaw, Michigan 48601 |
Saint John Macomb-Oakland Hospital | Warren, Michigan 48093 |
Unity Hospital | Fridley, Minnesota 55432 |
Saint John's Hospital - Healtheast | Maplewood, Minnesota 55109 |
Minnesota Oncology Hematology PA-Maplewood | Maplewood, Minnesota 55109 |
North Memorial Medical Health Center | Robbinsdale, Minnesota 55422 |
Park Nicollet Clinic - Saint Louis Park | Saint Louis Park, Minnesota 55416 |
Minnesota Oncology and Hematology PA-Woodbury | Woodbury, Minnesota 55125 |
Ozark Health Ventures LLC dba Cancer Research for The Ozarks Springfield | Springfield, Missouri 65802 |
Saint John's Hospital | Springfield, Missouri 65804 |
Cox Medical Center | Springfield, Missouri 65807 |
Billings Clinic | Billings, Montana 59107-7000 |
Benefis Healthcare- Sletten Cancer Institute | Great Falls, Montana 59405 |
Nevada Cancer Research Foundation CCOP | Las Vegas, Nevada 89106 |
Elliot Hospital | Manchester, New Hampshire 03103 |
Fox Chase Cancer Center at Virtua Memorial Hospital of Burlington County | Mount Holly, New Jersey 08060 |
Virtua West Jersey Hospital Voorhees | Voorhees, New Jersey 08043 |
State University of New York Upstate Medical University | Syracuse, New York 13210 |
Wayne Memorial Hospital | Goldsboro, North Carolina 27534 |
Aultman Health Foundation | Canton, Ohio 44710 |
Doctors Hospital | Columbus, Ohio 43228 |
Grant Medical Center | Columbus, Ohio 43215 |
Mount Carmel Health Center West | Columbus, Ohio 43222 |
Kettering Medical Center | Kettering, Ohio 45429 |
Marietta Memorial Hospital | Marietta, Ohio 45750 |
Saint Ann's Hospital | Westerville, Ohio 43081 |
Genesis HealthCare System | Zanesville, Ohio 43701 |
Saint Luke's Hospital | Bethlehem, Pennsylvania 18015 |
Mainline Health CCOP | Wynnewood, Pennsylvania 19096 |
Saint Vincent Hospital | Green Bay, Wisconsin 54301 |
Green Bay Oncology Limited at Saint Mary's Hospital | Green Bay, Wisconsin 54303 |
Saint Mary's Hospital | Green Bay, Wisconsin 54303 |
Green Bay Oncology at Saint Vincent Hospital | Green Bay, Wisconsin 54301-3526 |
Cancer Care Associates-Yale | Tulsa, Oklahoma 74136-1929 |
Lake University Ireland Cancer Center | Mentor, Ohio 44060 |
Stony Brook University Medical Center | Stony Brook, New York 11794 |
Lahey Clinic Medical Center | Burlington, Massachusetts 01805 |
University of Colorado Cancer Center - Anschutz Cancer Pavilion | Aurora, Colorado 80045 |
Cancer Center of Kansas-Liberal | Liberal, Kansas 67901 |
Olive View-University of California Los Angeles Medical Center | Sylmar, California 91342 |
Saint Elizabeth Medical Center South | Edgewood, Kentucky 41017 |
State University of New York Downstate Medical Center | Brooklyn, New York 11203 |
Monter Cancer Center | Lake Success, New York 11042 |
Chattanooga Gynecological Oncology | Chattanooga, Tennessee 37403 |
Aurora Women's Pavilion of Aurora West Allis Medical Center | West Allis, Wisconsin 53227 |
Kaiser Permanente Los Angeles Medical Center | Los Angeles, California 90027 |
Southwest Gynecologic Oncology Associates Inc | Albuquerque, New Mexico 87106 |
Women's Cancer Center of Nevada | Las Vegas, Nevada 89109 |
OSF Saint Francis Medical Center Radiation Oncology Service at the Central Illinois Comprehensive CC | Peoria, Illinois 61615-7827 |
Saint John's Clinic-Rolla-Cancer and Hematology | Rolla, Missouri 65401 |
The Mark H Zangmeister Center | Columbus, Ohio 43219 |
Southern Ohio Medical Center | Portsmouth, Ohio 45662 |
Gundersen Lutheran | La Crosse, Wisconsin 54601 |
Siouxland Hematology Oncology Associates | Sioux City, Iowa 51101 |
Palo Alto Medical Foundation-Gynecologic Oncology | Mountain View, California 94040 |
Sudarshan K Sharma MD Limted-Gynecologic Oncology | Hinsdale, Illinois 60521 |
University of Massachusetts Memorial Health Care | Worcester, Massachusetts 01605 |
The Women's Institute for Gynecologic Cancer and Special Pelvic Surgery | Phillipsburg, New Jersey 08865 |
Aurora Saint Luke's Medical Center | Milwaukee, Wisconsin 53215 |
Methodist West Hospital | West Des Moines, Iowa 50266-7700 |
Summa Akron City Hospital | Akron, Ohio 44304 |
Roy and Patricia Disney Family Cancer Center | Burbank, California 91505 |
Genesys Regional Medical Center-West Flint Campus | Flint, Michigan 48532 |
Christiana Care Health System-Christiana Hospital | Newark, Delaware 19718 |
Springfield Regional Medical Center | Springfield, Ohio 45505 |
Kaiser Permanente Medical Care Program - Los Angeles Medical Center & Sunset Hospital | Los Angeles, California 90027 |
Fletcher Allen Health Care-Medical Center | Burlington, Vermont 05401 |
Cancer Center of Western Wisconsin | New Richmond, Wisconsin 54017 |
Mercy Cancer Center-West Lakes | Clive, Iowa 50325 |
Mercy Medical Center-West Lakes | West Des Moines, Iowa 50266 |
Memorial Hermann Texas Medical Center | Houston, Texas 77030 |