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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 ClinicsIowa City, Iowa  52242
University of Mississippi Medical CenterJackson, Mississippi  39216-4505
Abington Memorial HospitalAbington, Pennsylvania  19001
Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111
Hurley Medical CenterFlint, Michigan  48503
Sinai Hospital of BaltimoreBaltimore, Maryland  21225
Genesys Hurley Cancer InstituteFlint, Michigan  48503
Bronson Methodist HospitalKalamazoo, Michigan  49007
West Michigan Cancer CenterKalamazoo, Michigan  49007-3731
Borgess Medical CenterKalamazooaa, Michigan  49001
Fairview Ridges HospitalBurnsville, Minnesota  55337
Hutchinson Area Health CareHutchinson, Minnesota  55350
United HospitalSt. Paul, Minnesota  55102
Ridgeview Medical CenterWaconia, Minnesota  55387
Avera Cancer InstituteSioux Falls, South Dakota  57105
Community Medical CenterToms River, New Jersey  08755
North Shore University HospitalManhasset, New York  11030
Hartford HospitalHartford, Connecticut  06102-5037
Baystate Medical CenterSpringfield, Massachusetts  01199
Via Christi Regional Medical CenterWichita, Kansas  67214
Wesley Medical CenterWichita, Kansas  67214
University of Oklahoma Health Sciences CenterOklahoma City, Oklahoma  73104
Iowa Methodist Medical CenterDes Moines, Iowa  50309
Iowa Lutheran HospitalDes Moines, Iowa  50316-2301
University of Wisconsin Hospital and ClinicsMadison, Wisconsin  53792-0001
Great Falls ClinicGreat Falls, Montana  59405
Valley HospitalRidgewood, New Jersey  07450
Long Island Jewish Medical CenterNew Hyde Park, New York  11040
Advocate Christ Medical CenterOak Lawn, Illinois  60453
Cancer Center of Kansas - ChanuteChanute, Kansas  66720
Cancer Center of Kansas - Dodge CityDodge City, Kansas  67801
Cancer Center of Kansas - NewtonNewton, Kansas  67114
Cancer Center of Kansas - SalinaSalina, Kansas  67042
Cancer Center of Kansas - WellingtonWellington, Kansas  67152
Associates in Womens HealthWichita, Kansas  67203
Cancer Center of Kansas - WinfieldWinfield, Kansas  67156
Adena Regional Medical CenterChillicothe, Ohio  54601
Grady Memorial HospitalDelaware, Ohio  43015
University of New Mexico Cancer CenterAlbuquerque, New Mexico  87131-5636
Good Samaritan Hospital - CincinnatiCincinnati, Ohio  45220
Methodist Estabrook Cancer CenterOmaha, Nebraska  68114-4199
Paoli Memorial HospitalPaoli, Pennsylvania  19301-1792
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical CenterColumbus, Ohio  43210-1240
Parkland Memorial HospitalDallas, Texas  75235
Beebe Medical CenterLewes, Delaware  19958
BroMenn Regional Medical CenterNormal, Illinois  61761
Valley Cancer CenterSpring Valley, Illinois  61362
Bryn Mawr HospitalBryn Mawr, Pennsylvania  19010
Mercy HospitalCoon Rapids, Minnesota  55433
Saint Joseph Medical CenterJoliet, Illinois  60435
Trinity Medical CenterMoline, Illinois  61265-1291
Medical Oncology and Hematology AssociatesDes Moines, Iowa  50309
Saint Joseph Mercy HospitalAnn Arbor, Michigan  48106
Fairview-Southdale HospitalEdina, Minnesota  55435
Abbott-Northwestern HospitalMinneapolis, Minnesota  55407
Regions HospitalSaint Paul, Minnesota  55101
Saint Francis Regional Medical CenterShakopee, Minnesota  55379
Rice Memorial HospitalWillmar, Minnesota  56201
Northeast Georgia Medical CenterGainesville, Georgia  30501
Cancer Center of Kansas - Fort ScottFort Scott, Kansas  66701
Cancer Center of Kansas-IndependenceIndependence, Kansas  67301
Lawrence Memorial HospitalLawrence, Kansas  66044
Woman's HospitalBaton Rouge, Louisiana  70815
Genesys Regional Medical CenterGrand Blanc, Michigan  48439-8066
Singing River HospitalPascagoula, Mississippi  39581
Zale Lipshy University HospitalDallas, Texas  75235-7786
Greater Baltimore Medical CenterBaltimore, Maryland  21204
Union Hospital of Cecil CountyElkton MD, Maryland  21921
Northwestern UniversityChicago, Illinois  60611
Memorial Medical CenterModesto, California  95355
Hennepin County Medical CenterMinneapolis, Minnesota  
Saint Alphonsus Regional Medical CenterBoise, Idaho  83706
University of California at San DiegoLa Jolla, California  92093
Case Western Reserve UniversityCleveland, Ohio  44106
Wayne State UniversityDetroit, Michigan  48202
University of Massachusetts Medical SchoolWorcester, Massachusetts  01605
Riverside Methodist HospitalColumbus, Ohio  43214
Licking Memorial HospitalNewark, Ohio  43055-2899
Columbus CCOPColumbus, Ohio  43206
Indiana University Medical CenterIndianapolis, Indiana  46202
University of Texas Southwestern Medical CenterDallas, Texas  
University of KentuckyLexington, Kentucky  40536-0098
Wichita CCOPWichita, Kansas  67214-3882
Montana Cancer Consortium CCOPBillings, Montana  59101
Huntsman Cancer Institute/University of UtahSalt Lake City, Utah  84112
Metro-Minnesota CCOPSt. Louis Park, Minnesota  
UC Davis Comprehensive Cancer CenterSacramento, California  95817
Lakeview HospitalStillwater, Minnesota  55082
Lankenau HospitalWynnewood, Pennsylvania  19096
Providence Saint Joseph Medical CenterBurbank, California  91505-4866
Memorial Health University Medical CenterSavannah, Georgia  31404
University of Chicago Comprehensive Cancer CenterChicago, Illinois  60637-1470
M D Anderson Cancer CenterHouston, Texas  77030
University of CincinnatiCincinnati, Ohio  45267-0502
New Ulm Medical CenterNew Ulm, Minnesota  56073
Wake Forest University Health SciencesWinston-Salem, North Carolina  27157
OSF Saint Francis Medical CenterPeoria, Illinois  61637
Northside HospitalAtlanta, Georgia  30342
Saint Francis Hospital and Medical CenterHartford, Connecticut  06105
The Hospital of Central ConnecticutNew Britain, Connecticut  06050
Saint Joseph's-Candler Health SystemSavannah, Georgia  31405
Rush - Copley Medical CenterAurora, Illinois  60504
Evanston CCOP-NorthShore University HealthSystemEvanston, Illinois  60201
Joliet Oncology-Hematology Associates LimitedJoliet, Illinois  60435
Community Cancer Center FoundationNormal, Illinois  61761
Illinois CancerCare-Ottawa ClinicOttawa, Illinois  61350
Ottawa Regional Hospital and Healthcare CenterOttawa, Illinois  61350
Illinois Oncology Research Association CCOPPeoria, Illinois  61615
Illinois CancerCare-PeoriaPeoria, Illinois  61615
Carle Clinic-Urbana MainUrbana, Illinois  61801
Saint Anthony Memorial Health CenterMichigan City, Indiana  46360
Medical Oncology and Hematology Associates-West Des MoinesClive, Iowa  50325
Iowa Oncology Research Association CCOPDes Moines, Iowa  50309
Mercy Medical Center - Des MoinesDes Moines, Iowa  50314
Medical Oncology and Hematology Associates-Des MoinesDes Moines, Iowa  50309
Mercy Medical Center-Sioux CitySioux City, Iowa  51104
Saint Luke's Regional Medical CenterSioux City, Iowa  51104
Cancer Center of Kansas - El DoradoEl Dorado, Kansas  67042
Cancer Center of Kansas-KingmanKingman, Kansas  67068
Cancer Center of Kansas - ParsonsParsons, Kansas  67357
Cancer Center of Kansas - PrattPratt, Kansas  67124
Cancer Center of Kansas-Wichita Medical Arts TowerWichita, Kansas  67208
Cancer Center of Kansas - Main OfficeWichita, Kansas  67214
Michigan Cancer Research Consortium Community Clinical Oncology ProgramAnn Arbor, Michigan  48106
Oakwood HospitalDearborn, Michigan  48123
Saint John Hospital and Medical CenterDetroit, Michigan  48236
Allegiance HealthJackson, Michigan  49201
Sparrow HospitalLansing, Michigan  48912
Saint Mary Mercy HospitalLivonia, Michigan  48154
Saint Joseph Mercy OaklandPontiac, Michigan  48341-2985
Saint Joseph Mercy Port HuronPort Huron, Michigan  48060
Saint Mary's of MichiganSaginaw, Michigan  48601
Saint John Macomb-Oakland HospitalWarren, Michigan  48093
Unity HospitalFridley, Minnesota  55432
Saint John's Hospital - HealtheastMaplewood, Minnesota  55109
Minnesota Oncology Hematology PA-MaplewoodMaplewood, Minnesota  55109
North Memorial Medical Health CenterRobbinsdale, Minnesota  55422
Park Nicollet Clinic - Saint Louis ParkSaint Louis Park, Minnesota  55416
Minnesota Oncology and Hematology PA-WoodburyWoodbury, Minnesota  55125
Ozark Health Ventures LLC dba Cancer Research for The Ozarks SpringfieldSpringfield, Missouri  65802
Saint John's HospitalSpringfield, Missouri  65804
Cox Medical CenterSpringfield, Missouri  65807
Billings ClinicBillings, Montana  59107-7000
Benefis Healthcare- Sletten Cancer InstituteGreat Falls, Montana  59405
Nevada Cancer Research Foundation CCOPLas Vegas, Nevada  89106
Elliot HospitalManchester, New Hampshire  03103
Fox Chase Cancer Center at Virtua Memorial Hospital of Burlington CountyMount Holly, New Jersey  08060
Virtua West Jersey Hospital VoorheesVoorhees, New Jersey  08043
State University of New York Upstate Medical UniversitySyracuse, New York  13210
Wayne Memorial HospitalGoldsboro, North Carolina  27534
Aultman Health FoundationCanton, Ohio  44710
Doctors HospitalColumbus, Ohio  43228
Grant Medical CenterColumbus, Ohio  43215
Mount Carmel Health Center WestColumbus, Ohio  43222
Kettering Medical CenterKettering, Ohio  45429
Marietta Memorial HospitalMarietta, Ohio  45750
Saint Ann's HospitalWesterville, Ohio  43081
Genesis HealthCare SystemZanesville, Ohio  43701
Saint Luke's HospitalBethlehem, Pennsylvania  18015
Mainline Health CCOPWynnewood, Pennsylvania  19096
Saint Vincent HospitalGreen Bay, Wisconsin  54301
Green Bay Oncology Limited at Saint Mary's HospitalGreen Bay, Wisconsin  54303
Saint Mary's HospitalGreen Bay, Wisconsin  54303
Green Bay Oncology at Saint Vincent HospitalGreen Bay, Wisconsin  54301-3526
Cancer Care Associates-YaleTulsa, Oklahoma  74136-1929
Lake University Ireland Cancer CenterMentor, Ohio  44060
Stony Brook University Medical CenterStony Brook, New York  11794
Lahey Clinic Medical CenterBurlington, Massachusetts  01805
University of Colorado Cancer Center - Anschutz Cancer PavilionAurora, Colorado  80045
Cancer Center of Kansas-LiberalLiberal, Kansas  67901
Olive View-University of California Los Angeles Medical CenterSylmar, California  91342
Saint Elizabeth Medical Center SouthEdgewood, Kentucky  41017
State University of New York Downstate Medical CenterBrooklyn, New York  11203
Monter Cancer CenterLake Success, New York  11042
Chattanooga Gynecological OncologyChattanooga, Tennessee  37403
Aurora Women's Pavilion of Aurora West Allis Medical CenterWest Allis, Wisconsin  53227
Kaiser Permanente Los Angeles Medical CenterLos Angeles, California  90027
Southwest Gynecologic Oncology Associates IncAlbuquerque, New Mexico  87106
Women's Cancer Center of NevadaLas Vegas, Nevada  89109
OSF Saint Francis Medical Center Radiation Oncology Service at the Central Illinois Comprehensive CCPeoria, Illinois  61615-7827
Saint John's Clinic-Rolla-Cancer and HematologyRolla, Missouri  65401
The Mark H Zangmeister CenterColumbus, Ohio  43219
Southern Ohio Medical CenterPortsmouth, Ohio  45662
Gundersen LutheranLa Crosse, Wisconsin  54601
Siouxland Hematology Oncology AssociatesSioux City, Iowa  51101
Palo Alto Medical Foundation-Gynecologic OncologyMountain View, California  94040
Sudarshan K Sharma MD Limted-Gynecologic OncologyHinsdale, Illinois  60521
University of Massachusetts Memorial Health CareWorcester, Massachusetts  01605
The Women's Institute for Gynecologic Cancer and Special Pelvic SurgeryPhillipsburg, New Jersey  08865
Aurora Saint Luke's Medical CenterMilwaukee, Wisconsin  53215
Methodist West HospitalWest Des Moines, Iowa  50266-7700
Summa Akron City HospitalAkron, Ohio  44304
Roy and Patricia Disney Family Cancer CenterBurbank, California  91505
Genesys Regional Medical Center-West Flint CampusFlint, Michigan  48532
Christiana Care Health System-Christiana HospitalNewark, Delaware  19718
Springfield Regional Medical CenterSpringfield, Ohio  45505
Kaiser Permanente Medical Care Program - Los Angeles Medical Center & Sunset HospitalLos Angeles, California  90027
Fletcher Allen Health Care-Medical CenterBurlington, Vermont  05401
Cancer Center of Western WisconsinNew Richmond, Wisconsin  54017
Mercy Cancer Center-West LakesClive, Iowa  50325
Mercy Medical Center-West LakesWest Des Moines, Iowa  50266
Memorial Hermann Texas Medical CenterHouston, Texas  77030