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Radiation Therapy With or Without Cisplatin in Treating Patients With Recurrent Endometrial Cancer

Sponsor
GOG Foundation (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT00492778
Collaborator
National Cancer Institute (NCI) (NIH)
164
Enrollment
441
Locations
2
Arms
0.4
Patients Per Site

Study Details

Study Description

Brief Summary

This randomized phase II trial studies radiation therapy and cisplatin to see how well they work compared with radiation therapy alone in treating patients with endometrial cancer that has come back. Radiation therapy uses high-energy x-rays and other types of radiation to kill tumor cells. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether giving radiation therapy together with cisplatin is more effective than radiation therapy alone in treating patients with endometrial cancer.

Condition or Disease Intervention/Treatment Phase
  • Radiation: 3-Dimensional Conformal Radiation Therapy
  • Drug: Cisplatin
  • Radiation: Intensity-Modulated Radiation Therapy
  • Radiation: Internal Radiation Therapy
 Phase 2

Detailed Description

PRIMARY OBJECTIVES:
  1. To assess whether pelvic radiation therapy with concurrent cisplatin is more promising with respect to progression-free survival than pelvic radiation therapy alone in the treatment of recurrent uterine carcinoma limited to the pelvis and vagina.
SECONDARY OBJECTIVES:

  1. To capture the sites of recurrence subsequent to treatment with pelvic radiation with or without concurrent weekly cisplatin in women with recurrent uterine carcinoma.

  2. To estimate overall survival of patients with recurrent uterine carcinoma treated with pelvic radiation therapy with or without concurrent weekly cisplatin.

  3. To estimate 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 of the histological subtype, grade, patient age, race, performance status, and the presence of lymph-vascular space involvement of the original tumor at the time of initial hysterectomy.

  4. To evaluate toxicity derived from the combined cisplatin and radiation compared with radiation alone in this patient population.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients undergo external-beam radiotherapy (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*.

ARM II: Patients undergo EBRT as in Arm I and receive cisplatin intravenously (IV) over 1-2 hours on days 1, 8, 15, 22, and 29. Patients then undergo brachytherapy* as in Arm I.

NOTE: *IMRT boost is allowed for patients who are not candidates for brachytherapy. IMRT may also be used for the entire course of therapy for the treatment of the whole pelvis and/or the boost in patients 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 up every month for 3 months, 3 months for 2 years and then every 6 months for 3 years.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
164 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Randomized Trial of Pelvic Irradiation With or Without Concurrent Weekly Cisplatin in Patients With Pelvic-Only Recurrence of Carcinoma of the Uterine Corpus
Actual Study Start Date :
Feb 25, 2008
Anticipated Primary Completion Date :
Jul 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Arm I (brachytherapy, radiation therapy)

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.

Radiation: 3-Dimensional Conformal Radiation Therapy
Undergo 3-dimensional conformal radiation therapy
Other Names:
  • 3-dimensional radiation therapy
  • 3D Conformal
  • 3D CONFORMAL RADIATION THERAPY
  • 3D CRT
  • 3D-CRT
  • Conformal Therapy
  • Radiation Conformal Therapy
  • Radiation, 3D Conformal

    • Radiation: Intensity-Modulated Radiation Therapy
    Undergo IMRT
    Other Names:
  • IMRT
  • Intensity Modulated RT
  • Intensity-Modulated Radiotherapy
  • Radiation, Intensity-Modulated Radiotherapy

    • Radiation: Internal Radiation Therapy
    Given intracavitarily or interstitially
    Other Names:
  • Brachytherapy
  • Brachytherapy, NOS
  • Internal Radiation
  • Internal Radiation Brachytherapy
  • Radiation Brachytherapy
  • Radiation, Internal

    		•
    Experimental: Arm II (brachytherapy, radiation therapy, cisplatin)

    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.

    Radiation: 3-Dimensional Conformal Radiation Therapy
    Undergo 3-dimensional conformal radiation therapy
    Other Names:
  • 3-dimensional radiation therapy
  • 3D Conformal
  • 3D CONFORMAL RADIATION THERAPY
  • 3D CRT
  • 3D-CRT
  • Conformal Therapy
  • Radiation Conformal Therapy
  • Radiation, 3D Conformal

    • Drug: Cisplatin
    Given IV
    Other Names:
  • Abiplatin
  • Blastolem
  • Briplatin
  • CDDP
  • Cis-diammine-dichloroplatinum
  • Cis-diamminedichloridoplatinum
  • Cis-diamminedichloro Platinum (II)
  • Cis-diamminedichloroplatinum
  • Cis-dichloroammine Platinum (II)
  • Cis-platinous Diamine Dichloride
  • Cis-platinum
  • Cis-platinum II
  • Cis-platinum II Diamine Dichloride
  • Cismaplat
  • Cisplatina
  • Cisplatinum
  • Cisplatyl
  • Citoplatino
  • Citosin
  • Cysplatyna
  • DDP
  • Lederplatin
  • Metaplatin
  • Neoplatin
  • Peyrone''s Chloride
  • Peyrone''s Salt
  • Placis
  • Plastistil
  • Platamine
  • Platiblastin
  • Platiblastin-S
  • Platinex
  • Platinol
  • Platinol- AQ
  • Platinol-AQ
  • Platinol-AQ VHA Plus
  • Platinoxan
  • Platinum
  • Platinum Diamminodichloride
  • Platiran
  • Platistin
  • Platosin

    • Radiation: Intensity-Modulated Radiation Therapy
    Undergo IMRT
    Other Names:
  • IMRT
  • Intensity Modulated RT
  • Intensity-Modulated Radiotherapy
  • Radiation, Intensity-Modulated Radiotherapy

    • Radiation: Internal Radiation Therapy
    Given intracavitarily or interstitially
    Other Names:
  • Brachytherapy
  • Brachytherapy, NOS
  • Internal Radiation
  • Internal Radiation Brachytherapy
  • Radiation Brachytherapy
  • Radiation, Internal

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Duration of progression-free survival [From study entry until disease progression, death, or date of last contact, assessed up to 5 years]

    Secondary Outcome Measures

    1. Duration of overall survival [From entry into the study to death or the date of last contact, assessed up to 5 years]

    2. Prognostic significance of tumor size, tumor location (vaginal only versus all others) and histology [Up to 5 years]

      Additionally, age, race, and tumor grade will be evaluated as prognostic factors. These analyses will help to define the appropriate population with sufficient risk for future studies involving therapy that is more aggressive. A proportional hazards model adjusted for performance status and treatment will be used to explore the relationship between these variables and progression-free survival or survival.

    3. Incidence of adverse effects [Up to 5 years]

      Graded by Common Terminology Criteria for Adverse Events version 3.0.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Sutter Auburn Faith Hospital Auburn California United States 95602
    2 Sutter Cancer Centers Radiation Oncology Services-Auburn Auburn California United States 95603
    3 Alta Bates Summit Medical Center-Herrick Campus Berkeley California United States 94704
    4 Providence Saint Joseph Medical Center/Disney Family Cancer Center Burbank California United States 91505
    5 Mills-Peninsula Medical Center Burlingame California United States 94010
    6 Sutter Cancer Centers Radiation Oncology Services-Cameron Park Cameron Park California United States 95682
    7 Eden Hospital Medical Center Castro Valley California United States 94546
    8 Sutter Davis Hospital Davis California United States 95616
    9 UC San Diego Moores Cancer Center La Jolla California United States 92093
    10 Loma Linda University Medical Center Loma Linda California United States 92354
    11 Kaiser Permanente Los Angeles Medical Center Los Angeles California United States 90027
    12 Memorial Medical Center Modesto California United States 95355
    13 Palo Alto Medical Foundation-Camino Division Mountain View California United States 94040
    14 Palo Alto Medical Foundation-Gynecologic Oncology Mountain View California United States 94040
    15 Sutter Cancer Research Consortium Novato California United States 94945
    16 UC Irvine Health/Chao Family Comprehensive Cancer Center Orange California United States 92868
    17 Palo Alto Medical Foundation Health Care Palo Alto California United States 94301
    18 Sutter Cancer Centers Radiation Oncology Services-Roseville Roseville California United States 95661
    19 Sutter Roseville Medical Center Roseville California United States 95661
    20 Sutter Medical Center Sacramento Sacramento California United States 95816
    21 University of California Davis Comprehensive Cancer Center Sacramento California United States 95817
    22 University of California San Diego San Diego California United States 92103
    23 California Pacific Medical Center-Pacific Campus San Francisco California United States 94115
    24 Palo Alto Medical Foundation-Santa Cruz Santa Cruz California United States 95065
    25 Sutter Pacific Medical Foundation Santa Rosa California United States 95403
    26 Palo Alto Medical Foundation-Sunnyvale Sunnyvale California United States 94086
    27 Olive View-University of California Los Angeles Medical Center Sylmar California United States 91342
    28 Sutter Cancer Centers Radiation Oncology Services-Vacaville Vacaville California United States 95687
    29 Sutter Solano Medical Center/Cancer Center Vallejo California United States 94589
    30 University of Colorado Hospital Aurora Colorado United States 80045
    31 Hartford Hospital Hartford Connecticut United States 06102
    32 Smilow Cancer Hospital Care Center at Saint Francis Hartford Connecticut United States 06105
    33 The Hospital of Central Connecticut New Britain Connecticut United States 06050
    34 Beebe Medical Center Lewes Delaware United States 19958
    35 Christiana Gynecologic Oncology LLC Newark Delaware United States 19713
    36 Delaware Clinical and Laboratory Physicians PA Newark Delaware United States 19713
    37 Helen F Graham Cancer Center Newark Delaware United States 19713
    38 Medical Oncology Hematology Consultants PA Newark Delaware United States 19713
    39 Christiana Care Health System-Christiana Hospital Newark Delaware United States 19718
    40 Beebe Health Campus Rehoboth Beach Delaware United States 19971
    41 TidalHealth Nanticoke / Allen Cancer Center Seaford Delaware United States 19973
    42 Christiana Care Health System-Wilmington Hospital Wilmington Delaware United States 19801
    43 Sibley Memorial Hospital Washington District of Columbia United States 20016
    44 Sarasota Memorial Hospital Sarasota Florida United States 34239
    45 Northside Hospital Atlanta Georgia United States 30342
    46 Augusta University Medical Center Augusta Georgia United States 30912
    47 Northeast Georgia Medical Center-Gainesville Gainesville Georgia United States 30501
    48 Memorial Health University Medical Center Savannah Georgia United States 31404
    49 Lewis Cancer and Research Pavilion at Saint Joseph's/Candler Savannah Georgia United States 31405
    50 Saint Alphonsus Cancer Care Center-Boise Boise Idaho United States 83706
    51 Saint Alphonsus Cancer Care Center-Caldwell Caldwell Idaho United States 83605
    52 Kootenai Health - Coeur d'Alene Coeur d'Alene Idaho United States 83814
    53 Walter Knox Memorial Hospital Emmett Idaho United States 83617
    54 Idaho Urologic Institute-Meridian Meridian Idaho United States 83642
    55 Saint Alphonsus Medical Center-Nampa Nampa Idaho United States 83686
    56 Kootenai Clinic Cancer Services - Post Falls Post Falls Idaho United States 83854
    57 Kootenai Cancer Clinic Sandpoint Idaho United States 83864
    58 Rush - Copley Medical Center Aurora Illinois United States 60504
    59 Saint Joseph Medical Center Bloomington Illinois United States 61701
    60 Illinois CancerCare-Bloomington Bloomington Illinois United States 61704
    61 Illinois CancerCare-Canton Canton Illinois United States 61520
    62 Illinois CancerCare-Carthage Carthage Illinois United States 62321
    63 Northwestern University Chicago Illinois United States 60611
    64 Rush University Medical Center Chicago Illinois United States 60612
    65 University of Chicago Comprehensive Cancer Center Chicago Illinois United States 60637
    66 Illinois CancerCare-Eureka Eureka Illinois United States 61530
    67 NorthShore University HealthSystem-Evanston Hospital Evanston Illinois United States 60201
    68 Illinois CancerCare-Galesburg Galesburg Illinois United States 61401
    69 Western Illinois Cancer Treatment Center Galesburg Illinois United States 61401
    70 Northwestern Medicine Cancer Center Delnor Geneva Illinois United States 60134
    71 Sudarshan K Sharma MD Limited-Gynecologic Oncology Hinsdale Illinois United States 60521
    72 Duly Health and Care Joliet Joliet Illinois United States 60435
    73 Illinois CancerCare-Kewanee Clinic Kewanee Illinois United States 61443
    74 Illinois CancerCare-Macomb Macomb Illinois United States 61455
    75 Loyola University Medical Center Maywood Illinois United States 60153
    76 Garneau, Stewart C MD (UIA Investigator) Moline Illinois United States 61265
    77 Spector, David MD (UIA Investigator) Moline Illinois United States 61265
    78 Trinity Medical Center Moline Illinois United States 61265
    79 Illinois CancerCare-Monmouth Monmouth Illinois United States 61462
    80 Bromenn Regional Medical Center Normal Illinois United States 61761
    81 Carle Cancer Institute Normal Normal Illinois United States 61761
    82 Advocate Christ Medical Center Oak Lawn Illinois United States 60453-2699
    83 Illinois CancerCare-Ottawa Clinic Ottawa Illinois United States 61350
    84 Ottawa Regional Hospital and Healthcare Center Ottawa Illinois United States 61350
    85 Illinois CancerCare-Pekin Pekin Illinois United States 61554
    86 OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center Pekin Illinois United States 61554
    87 Illinois CancerCare-Peoria Peoria Illinois United States 61615
    88 OSF Saint Francis Radiation Oncology at Peoria Cancer Center Peoria Illinois United States 61615
    89 Methodist Medical Center of Illinois Peoria Illinois United States 61636
    90 OSF Saint Francis Medical Center Peoria Illinois United States 61637
    91 Illinois CancerCare-Peru Peru Illinois United States 61354
    92 Valley Radiation Oncology Peru Illinois United States 61354
    93 Illinois CancerCare-Princeton Princeton Illinois United States 61356
    94 Northwestern Medicine Cancer Center Warrenville Warrenville Illinois United States 60555
    95 Parkview Hospital Randallia Fort Wayne Indiana United States 46805
    96 Parkview Regional Medical Center Fort Wayne Indiana United States 46845
    97 Indiana University/Melvin and Bren Simon Cancer Center Indianapolis Indiana United States 46202
    98 Franciscan Saint Anthony Health-Michigan City Michigan City Indiana United States 46360
    99 Memorial Regional Cancer Center Day Road Mishawaka Indiana United States 46545
    100 Memorial Hospital of South Bend South Bend Indiana United States 46601
    101 Constantinou, Costas L MD (UIA Investigator) Bettendorf Iowa United States 52722
    102 Mercy Hospital Cedar Rapids Iowa United States 52403
    103 Oncology Associates at Mercy Medical Center Cedar Rapids Iowa United States 52403
    104 Medical Oncology and Hematology Associates-West Des Moines Clive Iowa United States 50325
    105 Mercy Cancer Center-West Lakes Clive Iowa United States 50325
    106 Iowa Methodist Medical Center Des Moines Iowa United States 50309
    107 Medical Oncology and Hematology Associates-Des Moines Des Moines Iowa United States 50309
    108 Medical Oncology and Hematology Associates-Laurel Des Moines Iowa United States 50314
    109 Mercy Medical Center - Des Moines Des Moines Iowa United States 50314
    110 Iowa Lutheran Hospital Des Moines Iowa United States 50316
    111 University of Iowa/Holden Comprehensive Cancer Center Iowa City Iowa United States 52242
    112 Siouxland Regional Cancer Center Sioux City Iowa United States 51101
    113 Mercy Medical Center-Sioux City Sioux City Iowa United States 51102
    114 Saint Luke's Regional Medical Center Sioux City Iowa United States 51104
    115 Methodist West Hospital West Des Moines Iowa United States 50266-7700
    116 Mercy Medical Center-West Lakes West Des Moines Iowa United States 50266
    117 Cancer Center of Kansas - Chanute Chanute Kansas United States 66720
    118 Cancer Center of Kansas - Dodge City Dodge City Kansas United States 67801
    119 Cancer Center of Kansas - El Dorado El Dorado Kansas United States 67042
    120 Cancer Center of Kansas - Fort Scott Fort Scott Kansas United States 66701
    121 Central Care Cancer Center - Garden City Garden City Kansas United States 67846
    122 Central Care Cancer Center - Great Bend Great Bend Kansas United States 67530
    123 Cancer Center of Kansas-Independence Independence Kansas United States 67301
    124 Providence Medical Center Kansas City Kansas United States 66112
    125 Cancer Center of Kansas-Kingman Kingman Kansas United States 67068
    126 Lawrence Memorial Hospital Lawrence Kansas United States 66044
    127 Kansas Institute of Medicine Cancer and Blood Center Lenexa Kansas United States 66219
    128 Minimally Invasive Surgery Hospital Lenexa Kansas United States 66219
    129 Cancer Center of Kansas-Liberal Liberal Kansas United States 67905
    130 Cancer Center of Kansas-Manhattan Manhattan Kansas United States 66502
    131 Cancer Center of Kansas - McPherson McPherson Kansas United States 67460
    132 Cancer Center of Kansas - Newton Newton Kansas United States 67114
    133 Menorah Medical Center Overland Park Kansas United States 66209
    134 Saint Luke's South Hospital Overland Park Kansas United States 66213
    135 Cancer Center of Kansas - Parsons Parsons Kansas United States 67357
    136 Cancer Center of Kansas - Pratt Pratt Kansas United States 67124
    137 Cancer Center of Kansas - Salina Salina Kansas United States 67401
    138 Cancer Center of Kansas - Wellington Wellington Kansas United States 67152
    139 Associates In Womens Health Wichita Kansas United States 67208
    140 Cancer Center of Kansas-Wichita Medical Arts Tower Wichita Kansas United States 67208
    141 Ascension Via Christi Hospitals Wichita Wichita Kansas United States 67214
    142 Cancer Center of Kansas - Wichita Wichita Kansas United States 67214
    143 Wesley Medical Center Wichita Kansas United States 67214
    144 Cancer Center of Kansas - Winfield Winfield Kansas United States 67156
    145 Saint Elizabeth Medical Center South Edgewood Kentucky United States 41017
    146 University of Kentucky/Markey Cancer Center Lexington Kentucky United States 40536
    147 Woman's Hospital Baton Rouge Louisiana United States 70817
    148 Maine Medical Center-Bramhall Campus Portland Maine United States 04102
    149 Maine Medical Center- Scarborough Campus Scarborough Maine United States 04074
    150 Greater Baltimore Medical Center Baltimore Maryland United States 21204
    151 Sinai Hospital of Baltimore Baltimore Maryland United States 21215
    152 Christiana Care - Union Hospital Elkton Maryland United States 21921
    153 Lahey Hospital and Medical Center Burlington Massachusetts United States 01805
    154 Baystate Medical Center Springfield Massachusetts United States 01199
    155 UMass Memorial Medical Center - Memorial Division Worcester Massachusetts United States 01605
    156 UMass Memorial Medical Center - University Campus Worcester Massachusetts United States 01655
    157 Bixby Medical Center Adrian Michigan United States 49221
    158 Hickman Cancer Center Adrian Michigan United States 49221
    159 Saint Joseph Mercy Hospital Ann Arbor Michigan United States 48106
    160 McLaren Cancer Institute-Bay City Bay City Michigan United States 48706
    161 IHA Hematology Oncology Consultants-Brighton Brighton Michigan United States 48114
    162 Saint Joseph Mercy Brighton Brighton Michigan United States 48114
    163 IHA Hematology Oncology Consultants-Canton Canton Michigan United States 48188
    164 Saint Joseph Mercy Canton Canton Michigan United States 48188
    165 Caro Cancer Center Caro Michigan United States 48723
    166 IHA Hematology Oncology Consultants-Chelsea Chelsea Michigan United States 48118
    167 Saint Joseph Mercy Chelsea Chelsea Michigan United States 48118
    168 Hematology Oncology Consultants-Clarkston Clarkston Michigan United States 48346
    169 Newland Medical Associates-Clarkston Clarkston Michigan United States 48346
    170 Beaumont Hospital - Dearborn Dearborn Michigan United States 48124
    171 Wayne State University/Karmanos Cancer Institute Detroit Michigan United States 48201
    172 Ascension Saint John Hospital Detroit Michigan United States 48236
    173 Great Lakes Cancer Management Specialists-Doctors Park East China Township Michigan United States 48054
    174 Weisberg Cancer Treatment Center Farmington Hills Michigan United States 48334
    175 Genesee Cancer and Blood Disease Treatment Center Flint Michigan United States 48503
    176 Genesee Hematology Oncology PC Flint Michigan United States 48503
    177 Genesys Hurley Cancer Institute Flint Michigan United States 48503
    178 Hurley Medical Center Flint Michigan United States 48503
    179 Genesys Regional Medical Center-West Flint Campus Flint Michigan United States 48532
    180 McLaren Cancer Institute-Flint Flint Michigan United States 48532
    181 Singh and Arora Hematology Oncology PC Flint Michigan United States 48532
    182 Genesys Regional Medical Center Grand Blanc Michigan United States 48439
    183 Academic Hematology Oncology Specialists Grosse Pointe Woods Michigan United States 48236
    184 Great Lakes Cancer Management Specialists-Van Elslander Cancer Center Grosse Pointe Woods Michigan United States 48236
    185 Michigan Breast Specialists-Grosse Pointe Woods Grosse Pointe Woods Michigan United States 48236
    186 Allegiance Health Jackson Michigan United States 49201
    187 Bronson Methodist Hospital Kalamazoo Michigan United States 49007
    188 West Michigan Cancer Center Kalamazoo Michigan United States 49007
    189 Borgess Medical Center Kalamazoo Michigan United States 49048
    190 Sparrow Hospital Lansing Michigan United States 48912
    191 McLaren Cancer Institute-Lapeer Region Lapeer Michigan United States 48446
    192 Hope Cancer Clinic Livonia Michigan United States 48154
    193 Saint Mary Mercy Hospital Livonia Michigan United States 48154
    194 Great Lakes Cancer Management Specialists-Macomb Medical Campus Macomb Michigan United States 48044
    195 Michigan Breast Specialists-Macomb Township Macomb Michigan United States 48044
    196 Saint Mary's Oncology/Hematology Associates of Marlette Marlette Michigan United States 48453
    197 Toledo Clinic Cancer Centers-Monroe Monroe Michigan United States 48162
    198 21st Century Oncology-Pontiac Pontiac Michigan United States 48341
    199 Hope Cancer Center Pontiac Michigan United States 48341
    200 Newland Medical Associates-Pontiac Pontiac Michigan United States 48341
    201 Saint Joseph Mercy Oakland Pontiac Michigan United States 48341
    202 Lake Huron Medical Center Port Huron Michigan United States 48060
    203 Great Lakes Cancer Management Specialists-Rochester Hills Rochester Hills Michigan United States 48309
    204 Ascension Saint Mary's Hospital Saginaw Michigan United States 48601
    205 Oncology Hematology Associates of Saginaw Valley PC Saginaw Michigan United States 48604
    206 Bhadresh Nayak MD PC-Sterling Heights Sterling Heights Michigan United States 48312
    207 Advanced Breast Care Center PLLC Warren Michigan United States 48088
    208 Great Lakes Cancer Management Specialists-Macomb Professional Building Warren Michigan United States 48093
    209 Macomb Hematology Oncology PC Warren Michigan United States 48093
    210 Michigan Breast Specialists-Warren Warren Michigan United States 48093
    211 Saint John Macomb-Oakland Hospital Warren Michigan United States 48093
    212 Saint Mary's Oncology/Hematology Associates of West Branch West Branch Michigan United States 48661
    213 Huron Gastroenterology PC Ypsilanti Michigan United States 48106
    214 IHA Hematology Oncology Consultants-Ann Arbor Ypsilanti Michigan United States 48197
    215 Fairview Ridges Hospital Burnsville Minnesota United States 55337
    216 Mercy Hospital Coon Rapids Minnesota United States 55433
    217 Fairview Southdale Hospital Edina Minnesota United States 55435
    218 Unity Hospital Fridley Minnesota United States 55432
    219 Hutchinson Area Health Care Hutchinson Minnesota United States 55350
    220 Minnesota Oncology Hematology PA-Maplewood Maplewood Minnesota United States 55109
    221 Saint John's Hospital - Healtheast Maplewood Minnesota United States 55109
    222 Abbott-Northwestern Hospital Minneapolis Minnesota United States 55407
    223 Hennepin County Medical Center Minneapolis Minnesota United States 55415
    224 Health Partners Inc Minneapolis Minnesota United States 55454
    225 New Ulm Medical Center New Ulm Minnesota United States 56073
    226 North Memorial Medical Health Center Robbinsdale Minnesota United States 55422
    227 Park Nicollet Clinic - Saint Louis Park Saint Louis Park Minnesota United States 55416
    228 Regions Hospital Saint Paul Minnesota United States 55101
    229 United Hospital Saint Paul Minnesota United States 55102
    230 Saint Francis Regional Medical Center Shakopee Minnesota United States 55379
    231 Lakeview Hospital Stillwater Minnesota United States 55082
    232 Ridgeview Medical Center Waconia Minnesota United States 55387
    233 Rice Memorial Hospital Willmar Minnesota United States 56201
    234 Minnesota Oncology Hematology PA-Woodbury Woodbury Minnesota United States 55125
    235 University of Mississippi Medical Center Jackson Mississippi United States 39216
    236 Singing River Hospital Pascagoula Mississippi United States 39581
    237 Central Care Cancer Center - Bolivar Bolivar Missouri United States 65613
    238 University of Missouri - Ellis Fischel Columbia Missouri United States 65212
    239 Centerpoint Medical Center LLC Independence Missouri United States 64057
    240 Freeman Health System Joplin Missouri United States 64804
    241 Saint Luke's Hospital of Kansas City Kansas City Missouri United States 64111
    242 Heartland Hematology and Oncology Associates Incorporated Kansas City Missouri United States 64118
    243 Research Medical Center Kansas City Missouri United States 64132
    244 Saint Luke's East - Lee's Summit Lee's Summit Missouri United States 64086
    245 Liberty Radiation Oncology Center Liberty Missouri United States 64068
    246 Mercy Clinic-Rolla-Cancer and Hematology Rolla Missouri United States 65401
    247 Heartland Regional Medical Center Saint Joseph Missouri United States 64506
    248 Saint Joseph Oncology Inc Saint Joseph Missouri United States 64507
    249 Barnes-Jewish Hospital Saint Louis Missouri United States 63110
    250 Washington University School of Medicine Saint Louis Missouri United States 63110
    251 Mercy Hospital Springfield Springfield Missouri United States 65804
    252 CoxHealth South Hospital Springfield Missouri United States 65807
    253 Community Hospital of Anaconda Anaconda Montana United States 59711
    254 Billings Clinic Cancer Center Billings Montana United States 59101
    255 Saint Vincent Healthcare Billings Montana United States 59101
    256 Bozeman Deaconess Hospital Bozeman Montana United States 59715
    257 Saint James Community Hospital and Cancer Treatment Center Butte Montana United States 59701
    258 Benefis Healthcare- Sletten Cancer Institute Great Falls Montana United States 59405
    259 Great Falls Clinic Great Falls Montana United States 59405
    260 Saint Peter's Community Hospital Helena Montana United States 59601
    261 Kalispell Regional Medical Center Kalispell Montana United States 59901
    262 Saint Patrick Hospital - Community Hospital Missoula Montana United States 59802
    263 Community Medical Hospital Missoula Montana United States 59804
    264 Nebraska Methodist Hospital Omaha Nebraska United States 68114
    265 Cancer and Blood Specialists-Henderson Henderson Nevada United States 89052
    266 Comprehensive Cancer Centers of Nevada - Henderson Henderson Nevada United States 89052
    267 Las Vegas Cancer Center-Henderson Henderson Nevada United States 89052
    268 21st Century Oncology-Henderson Henderson Nevada United States 89074
    269 Comprehensive Cancer Centers of Nevada-Southeast Henderson Henderson Nevada United States 89074
    270 University Medical Center of Southern Nevada Las Vegas Nevada United States 89102
    271 Cancer and Blood Specialists-Shadow Las Vegas Nevada United States 89106
    272 Radiation Oncology Centers of Nevada Central Las Vegas Nevada United States 89106
    273 21st Century Oncology Las Vegas Nevada United States 89109
    274 HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway Las Vegas Nevada United States 89109
    275 HealthCare Partners Medical Group Oncology/Hematology-San Martin Las Vegas Nevada United States 89113
    276 Radiation Oncology Centers of Nevada Southeast Las Vegas Nevada United States 89119
    277 Cancer Therapy and Integrative Medicine Las Vegas Nevada United States 89121
    278 21st Century Oncology-Vegas Tenaya Las Vegas Nevada United States 89128
    279 Cancer and Blood Specialists-Tenaya Las Vegas Nevada United States 89128
    280 Comprehensive Cancer Centers of Nevada - Northwest Las Vegas Nevada United States 89128
    281 HealthCare Partners Medical Group Oncology/Hematology-Tenaya Las Vegas Nevada United States 89128
    282 Comprehensive Cancer Centers of Nevada-Summerlin Las Vegas Nevada United States 89144
    283 Las Vegas Cancer Center-Medical Center Las Vegas Nevada United States 89148-2405
    284 21st Century Oncology-Fort Apache Las Vegas Nevada United States 89148
    285 Comprehensive Cancer Centers of Nevada Las Vegas Nevada United States 89148
    286 OptumCare Cancer Care at Fort Apache Las Vegas Nevada United States 89148
    287 HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills Las Vegas Nevada United States 89149
    288 Comprehensive Cancer Centers of Nevada - Central Valley Las Vegas Nevada United States 89169
    289 Women's Cancer Center of Nevada Las Vegas Nevada United States 89169
    290 Wentworth-Douglass Hospital Dover New Hampshire United States 03820
    291 Dartmouth Hitchcock Medical Center Lebanon New Hampshire United States 03756
    292 Elliot Hospital Manchester New Hampshire United States 03103
    293 Cooper Hospital University Medical Center Camden New Jersey United States 08103
    294 Virtua Memorial Mount Holly New Jersey United States 08060
    295 Jersey Shore Medical Center Neptune New Jersey United States 07753
    296 Rutgers New Jersey Medical School Newark New Jersey United States 07101
    297 The Valley Hospital-Luckow Pavilion Paramus New Jersey United States 07652
    298 Valley Hospital Ridgewood New Jersey United States 07450
    299 Community Medical Center Toms River New Jersey United States 08755
    300 MD Anderson Cancer Center at Cooper-Voorhees Voorhees New Jersey United States 08043
    301 Virtua Voorhees Voorhees New Jersey United States 08043
    302 Valley Health System-Hematology/Oncology Westwood New Jersey United States 07675
    303 University of New Mexico Cancer Center Albuquerque New Mexico United States 87102
    304 Southwest Gynecologic Oncology Associates Inc Albuquerque New Mexico United States 87106
    305 State University of New York Downstate Medical Center Brooklyn New York United States 11203
    306 Northwell Health/Center for Advanced Medicine Lake Success New York United States 11042
    307 North Shore University Hospital Manhasset New York United States 11030
    308 Long Island Jewish Medical Center New Hyde Park New York United States 11040
    309 Highland Hospital Rochester New York United States 14620
    310 University of Rochester Rochester New York United States 14642
    311 Stony Brook University Medical Center Stony Brook New York United States 11794
    312 State University of New York Upstate Medical University Syracuse New York United States 13210
    313 Novant Health Presbyterian Medical Center Charlotte North Carolina United States 28204
    314 Southeastern Medical Oncology Center-Clinton Clinton North Carolina United States 28328
    315 Southeastern Medical Oncology Center-Goldsboro Goldsboro North Carolina United States 27534
    316 Wayne Memorial Hospital Goldsboro North Carolina United States 27534
    317 Novant Health Presbyterian Medical Center Huntersville Huntersville North Carolina United States 28078
    318 Southeastern Medical Oncology Center-Jacksonville Jacksonville North Carolina United States 28546
    319 Wake Forest University Health Sciences Winston-Salem North Carolina United States 27157
    320 Summa Health System - Akron Campus Akron Ohio United States 44304
    321 UHHS-Chagrin Highlands Medical Center Beachwood Ohio United States 44122
    322 Strecker Cancer Center-Belpre Belpre Ohio United States 45714
    323 Aultman Health Foundation Canton Ohio United States 44710
    324 Miami Valley Hospital South Centerville Ohio United States 45459
    325 Adena Regional Medical Center Chillicothe Ohio United States 45601
    326 University of Cincinnati Cancer Center-UC Medical Center Cincinnati Ohio United States 45219
    327 Good Samaritan Hospital - Cincinnati Cincinnati Ohio United States 45220
    328 Bethesda North Hospital Cincinnati Ohio United States 45242
    329 Case Western Reserve University Cleveland Ohio United States 44106
    330 Cleveland Clinic Cancer Center/Fairview Hospital Cleveland Ohio United States 44111
    331 Cleveland Clinic Foundation Cleveland Ohio United States 44195
    332 Ohio State University Comprehensive Cancer Center Columbus Ohio United States 43210
    333 Mount Carmel East Hospital Columbus Ohio United States 43213
    334 Columbus Oncology and Hematology Associates Inc Columbus Ohio United States 43214
    335 Riverside Methodist Hospital Columbus Ohio United States 43214
    336 Grant Medical Center Columbus Ohio United States 43215
    337 The Mark H Zangmeister Center Columbus Ohio United States 43219
    338 Mount Carmel Health Center West Columbus Ohio United States 43222
    339 Doctors Hospital Columbus Ohio United States 43228
    340 Grandview Hospital Dayton Ohio United States 45405
    341 Delaware Health Center-Grady Cancer Center Delaware Ohio United States 43015
    342 Delaware Radiation Oncology Delaware Ohio United States 43015
    343 Grady Memorial Hospital Delaware Ohio United States 43015
    344 Dublin Methodist Hospital Dublin Ohio United States 43016
    345 Mount Carmel Grove City Hospital Grove City Ohio United States 43123
    346 Kettering Medical Center Kettering Ohio United States 45429
    347 Fairfield Medical Center Lancaster Ohio United States 43130
    348 Lancaster Radiation Oncology Lancaster Ohio United States 43130
    349 OhioHealth Mansfield Hospital Mansfield Ohio United States 44903
    350 Marietta Memorial Hospital Marietta Ohio United States 45750
    351 OhioHealth Marion General Hospital Marion Ohio United States 43302
    352 Toledo Clinic Cancer Centers-Maumee Maumee Ohio United States 43537
    353 Toledo Radiation Oncology at Northwest Ohio Onocolgy Center Maumee Ohio United States 43537
    354 Hillcrest Hospital Cancer Center Mayfield Heights Ohio United States 44124
    355 UH Seidman Cancer Center at Landerbrook Health Center Mayfield Heights Ohio United States 44124
    356 UH Seidman Cancer Center at Lake Health Mentor Campus Mentor Ohio United States 44060
    357 Knox Community Hospital Mount Vernon Ohio United States 43050
    358 Licking Memorial Hospital Newark Ohio United States 43055
    359 Newark Radiation Oncology Newark Ohio United States 43055
    360 Saint Charles Hospital Oregon Ohio United States 43616
    361 Southern Ohio Medical Center Portsmouth Ohio United States 45662
    362 Springfield Regional Medical Center Springfield Ohio United States 45505
    363 ProMedica Flower Hospital Sylvania Ohio United States 43560
    364 ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital Toledo Ohio United States 43606
    365 University of Toledo Toledo Ohio United States 43614
    366 Toledo Community Hospital Oncology Program CCOP Toledo Ohio United States 43617
    367 Mercy Health - Saint Anne Hospital Toledo Ohio United States 43623
    368 Toledo Clinic Cancer Centers-Toledo Toledo Ohio United States 43623
    369 University Hospitals Sharon Health Center Wadsworth Ohio United States 44281
    370 University of Cincinnati Cancer Center-West Chester West Chester Ohio United States 45069
    371 Saint Ann's Hospital Westerville Ohio United States 43081
    372 UHHS-Westlake Medical Center Westlake Ohio United States 44145
    373 Genesis Healthcare System Cancer Care Center Zanesville Ohio United States 43701
    374 University of Oklahoma Health Sciences Center Oklahoma City Oklahoma United States 73104
    375 Oklahoma Cancer Specialists and Research Institute-Tulsa Tulsa Oklahoma United States 74146
    376 Saint Alphonsus Medical Center-Baker City Baker City Oregon United States 97814
    377 Legacy Mount Hood Medical Center Gresham Oregon United States 97030
    378 Saint Alphonsus Medical Center-Ontario Ontario Oregon United States 97914
    379 Legacy Good Samaritan Hospital and Medical Center Portland Oregon United States 97210
    380 Providence Portland Medical Center Portland Oregon United States 97213
    381 Legacy Meridian Park Hospital Tualatin Oregon United States 97062
    382 Jefferson Abington Hospital Abington Pennsylvania United States 19001
    383 Lehigh Valley Hospital-Cedar Crest Allentown Pennsylvania United States 18103
    384 Saint Luke's University Hospital-Bethlehem Campus Bethlehem Pennsylvania United States 18015
    385 Lehigh Valley Hospital - Muhlenberg Bethlehem Pennsylvania United States 18017
    386 Bryn Mawr Hospital Bryn Mawr Pennsylvania United States 19010
    387 Geisinger Medical Center Danville Pennsylvania United States 17822
    388 Delaware County Memorial Hospital Drexel Hill Pennsylvania United States 19026
    389 Pocono Medical Center East Stroudsburg Pennsylvania United States 18301
    390 Adams Cancer Center Gettysburg Pennsylvania United States 17325
    391 Cherry Tree Cancer Center Hanover Pennsylvania United States 17331
    392 Geisinger Medical Oncology-Lewisburg Lewisburg Pennsylvania United States 17837
    393 Lewistown Hospital Lewistown Pennsylvania United States 17044
    394 Paoli Memorial Hospital Paoli Pennsylvania United States 19301
    395 Fox Chase Cancer Center Philadelphia Pennsylvania United States 19111
    396 Reading Hospital West Reading Pennsylvania United States 19611
    397 Geisinger Wyoming Valley/Henry Cancer Center Wilkes-Barre Pennsylvania United States 18711
    398 Lankenau Medical Center Wynnewood Pennsylvania United States 19096
    399 WellSpan Health-York Cancer Center York Pennsylvania United States 17403
    400 WellSpan Health-York Hospital York Pennsylvania United States 17403
    401 Prisma Health Cancer Institute - Spartanburg Boiling Springs South Carolina United States 29316
    402 Prisma Health Cancer Institute - Easley Easley South Carolina United States 29640
    403 Greenville Health System Cancer Institute-Andrews Greenville South Carolina United States 29601
    404 Prisma Health Cancer Institute - Butternut Greenville South Carolina United States 29605
    405 Prisma Health Cancer Institute - Faris Greenville South Carolina United States 29605
    406 Prisma Health Greenville Memorial Hospital Greenville South Carolina United States 29605
    407 Prisma Health Cancer Institute - Eastside Greenville South Carolina United States 29615
    408 Prisma Health Cancer Institute - Greer Greer South Carolina United States 29650
    409 Prisma Health Cancer Institute - Seneca Seneca South Carolina United States 29672
    410 Spartanburg Medical Center Spartanburg South Carolina United States 29303
    411 Avera Cancer Institute Sioux Falls South Dakota United States 57105
    412 Chattanooga Gynecological Oncology Chattanooga Tennessee United States 37403
    413 University of Tennessee - Knoxville Knoxville Tennessee United States 37920
    414 Parkland Memorial Hospital Dallas Texas United States 75235
    415 UT Southwestern/Simmons Cancer Center-Dallas Dallas Texas United States 75390
    416 Houston Methodist Hospital Houston Texas United States 77030
    417 M D Anderson Cancer Center Houston Texas United States 77030
    418 Memorial Hermann Texas Medical Center Houston Texas United States 77030
    419 Methodist Willowbrook Hospital Houston Texas United States 77070
    420 Houston Methodist Sugar Land Hospital Sugar Land Texas United States 77479
    421 Huntsman Cancer Institute/University of Utah Salt Lake City Utah United States 84112
    422 South Jordan Health Center South Jordan Utah United States 84009
    423 University of Vermont Medical Center Burlington Vermont United States 05401
    424 University of Vermont and State Agricultural College Burlington Vermont United States 05405
    425 Legacy Salmon Creek Hospital Vancouver Washington United States 98686
    426 West Virginia University Healthcare Morgantown West Virginia United States 26506
    427 Green Bay Oncology at Saint Vincent Hospital Green Bay Wisconsin United States 54301-3526
    428 Saint Vincent Hospital Cancer Center Green Bay Green Bay Wisconsin United States 54301
    429 Green Bay Oncology Limited at Saint Mary's Hospital Green Bay Wisconsin United States 54303
    430 Saint Vincent Hospital Cancer Center at Saint Mary's Green Bay Wisconsin United States 54303
    431 Gundersen Lutheran Medical Center La Crosse Wisconsin United States 54601
    432 University of Wisconsin Hospital and Clinics Madison Wisconsin United States 53792
    433 Aurora Saint Luke's Medical Center Milwaukee Wisconsin United States 53215
    434 Cancer Center of Western Wisconsin New Richmond Wisconsin United States 54017
    435 Aurora West Allis Medical Center West Allis Wisconsin United States 53227
    436 Rocky Mountain Oncology Casper Wyoming United States 82609
    437 Big Horn Basin Cancer Center Cody Wyoming United States 82414
    438 Billings Clinic-Cody Cody Wyoming United States 82414
    439 Welch Cancer Center Sheridan Wyoming United States 82801
    440 CHUM - Hopital Notre-Dame Montreal Quebec Canada H2L 4M1
    441 CHUM - Centre Hospitalier de l'Universite de Montreal Montreal Quebec Canada H2X 3E4

    Sponsors and Collaborators

    • GOG Foundation
    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Jonathan M Feddock, NRG Oncology

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    GOG Foundation
    ClinicalTrials.gov Identifier:
    NCT00492778
    Other Study ID Numbers:
    • GOG-0238
    • NCI-2009-00603
    • CDR0000550975
    • GOG-0238
    • GOG-0238
    • GOG-0238
    • U10CA180868
    • U10CA027469
    First Posted:
    Jun 27, 2007
    Last Update Posted:
    Oct 6, 2021
    Last Verified:
    Sep 1, 2021
    Additional relevant MeSH terms:
    Carcinoma
    Adenocarcinoma
    Cystadenocarcinoma, Serous
    Carcinoma, Endometrioid
    Adenocarcinoma, Clear Cell
    Adenocarcinoma, Mucinous
    Cystadenocarcinoma
    Recurrence
    Cisplatin

    Study Results

    No Results Posted as of Oct 6, 2021