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A Randomized Trial of Pelvic Irradiation With or Without Concurrent Weekly Cisplatin in Patients With Pelvic-Only Recurrence of Carcinoma of the Uterine Corpus


Phase 2
N/A
N/A
Open (Enrolling)
Female
Endometrial Cancer

Thank you

Trial Information

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.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed diagnosis of endometrial cancer, including the following
histological subtypes:

- Adenocarcinoma

- Adenocarcinoma with squamous differentiation

- Mucinous adenocarcinoma

- Squamous cell carcinoma

- Mixed carcinoma

- Undifferentiated carcinoma

- Clear cell adenocarcinoma

- Serous adenocarcinoma

- Must have undergone prior complete hysterectomy and bilateral salpingo-oophorectomy
at the time of original therapy

- Recurrent disease confined to the pelvis and/or vagina

- No evidence of extrapelvic disease, including positive periaortic or
inguino-femoral nodes by chest x-ray or CT scan

- Prior primary surgical debulking (including removal of gross symptomatic disease in
the pelvis and/or vagina) allowed provided there is residual disease that is
evaluable clinically and/or by CT scan or MRI

- Exenterative surgery is not permissible

- Patients who have undergone prior complete surgical resection of the recurrent
tumor and have no evidence of residual disease evaluable clinically and by CT
scan or MRI after resection are not eligible

- Patients enrolled subsequent to revision 11 with complete resection of
gross recurrent disease are eligible

- Patients with ureteral obstruction must undergo stent or nephrostomy tube placement
prior to study entry

PATIENT CHARACTERISTICS:

- GOG performance status 0-2

- Life expectancy ≥ 3 months

- Absolute neutrophil count ≥ 1,500/mm³

- Platelet count ≥ 100,000/mm³

- Creatinine normal OR creatinine clearance > 50 mL/min

- Bilirubin ≤ 1.5 times upper limit of normal (ULN)

- SGOT ≤ 2.5 times ULN

- Alkaline phosphatase ≤ 2.5 times ULN

- No sensory or motor neuropathy > grade 1

- No septicemia or severe infection

- No circumstances that would preclude study participation

- No renal abnormalities (i.e., pelvic kidney, horseshoe kidney, or prior renal
transplantation) that would require modification of radiation fields

- No other invasive malignancies within the past 5 years except nonmelanoma skin cancer

- No significant history of cardiac disease, including uncontrolled hypertension,
unstable angina, congestive heart failure, or uncontrolled arrhythmias within the
past 6 months

- No history of active collagen vascular disease

PRIOR CONCURRENT THERAPY:

- At least 6 months since prior hormone therapy and/or systemic chemotherapy

- No prior neoadjuvant chemotherapy for recurrent disease

- No prior exenterative surgery

- No prior vaginal, pelvic, or abdominal irradiation

- No prior chemotherapy directed at the present recurrent disease

- No prior cancer treatment that would preclude study treatment

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Duration of progression-free survival

Safety Issue:

No

Principal Investigator

Shu-Yuan Liao, MD

Investigator Role:

Study Chair

Investigator Affiliation:

St. Joseph Hospital Health Center

Authority:

United States: NCI, OHRP

Study ID:

GOG-0238

NCT ID:

NCT00492778

Start Date:

February 2008

Completion Date:

Related Keywords:

  • Endometrial Cancer
  • recurrent endometrial carcinoma
  • endometrial adenoacanthoma
  • endometrial adenocarcinoma
  • endometrial adenosquamous cell carcinoma
  • endometrial clear cell carcinoma
  • endometrial papillary serous carcinoma
  • Endometrial Neoplasms
  • Sarcoma, Endometrial Stromal
  • Adenoma

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