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WHOLE ABDOMINAL RADIOTHERAPY VERSUS CIRCADIAN-TIMED COMBINATION DOXORUBICIN-CISPLATIN CHEMOTHERAPY IN ADVANCED ENDOMETRIAL CARCINOMA -- PHASE III


Phase 3
N/A
N/A
Not Enrolling
Female
Endometrial Cancer, Psychosocial Effects of Cancer and Its Treatment

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Trial Information

WHOLE ABDOMINAL RADIOTHERAPY VERSUS CIRCADIAN-TIMED COMBINATION DOXORUBICIN-CISPLATIN CHEMOTHERAPY IN ADVANCED ENDOMETRIAL CARCINOMA -- PHASE III


OBJECTIVES: I. Compare overall survival, progression-free interval, and patterns of failure
of maximally debulked patients with stage III/IV endometrial carcinoma treated with
whole-abdominal irradiation vs. doxorubicin/cisplatin. II. Compare the incidence and type of
acute and late adverse events observed with these two treatment regimens. III. Compare
changes in fatigue, elimination, and neurologic impairment that impact on quality of life in
patients treated with these two regimens. IV. Assess the difference in short-term versus
long-term impact on quality of life between the two treatment groups. V. Compare
quality-of-life outcomes over time between these two treatment groups.

OUTLINE: Randomized study. Arm I: Radiotherapy. Whole-abdominal irradiation using equipment
with photon energies ranging from 6 to 25 MV. Arm II: 2-Drug Combination Chemotherapy.
Doxorubicin, DOX, NSC-123127; Cisplatin, CDDP, NSC-119875.

PROJECTED ACCRUAL: It is anticipated that 355 patients will be entered over 7.4 years.

Inclusion Criteria


DISEASE CHARACTERISTICS: Pathological stage III/IV endometrial carcinoma of any histology
(including clear cell and serous papillary carcinomas) The following extent of disease
eligible: Positive adnexa Tumor invading the serosa Positive pelvic nodes Positive
para-aortic nodes Involvement of the bowel mucosa Intra-abdominal metastases Positive
pelvic washings Vaginal involvement within the radiotherapy field Hysterectomy and
bilateral salpingo-oophorectomy (BSO) required with residual tumor not greater than 2 cm
at any site Selective pelvic and para-aortic lymph node sampling optional for patients
with stage III/IV disease by other criteria If para-aortic nodes are positive, scalene
nodes must be negative on biopsy and chest CT must be negative for intrathoracic disease
The following disease conditions exclude: Parenchymal liver metastasis Lung metastasis
Positive inguinal nodes Positive scalene nodes Recurrent disease Protocol therapy must
begin within 8 weeks after surgery

PATIENT CHARACTERISTICS: Age: Not specified Performance status: GOG 0-3 Hematopoietic: WBC
at least 3,000/mm3 Absolute granulocyte count at least 1,500/mm3 Platelet count at least
100,000/mm3 Hepatic: Bilirubin no greater than 1.5 times normal AST no greater than 3
times normal Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: Left ventricular
ejection fraction normal Other: No past or concomitant malignancy other than
nonmelanomatous skin cancer

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior biologic therapy Chemotherapy: No
prior chemotherapy Endocrine therapy: Prior progestational agents allowed No other prior
endocrine therapy Radiotherapy: No prior pelvic or abdominal radiotherapy Surgery:
Hysterectomy and BSO required Pelvic and para-aortic lymph node sampling optional (see
Disease Characteristics)

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Marcus E. Randall, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Indiana University Melvin and Bren Simon Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000077572

NCT ID:

NCT00002493

Start Date:

May 1992

Completion Date:

Related Keywords:

  • Endometrial Cancer
  • Psychosocial Effects of Cancer and Its Treatment
  • stage III endometrial carcinoma
  • stage IV endometrial carcinoma
  • endometrial adenocarcinoma
  • endometrial adenosquamous cell carcinoma
  • endometrial adenoacanthoma
  • endometrial papillary serous carcinoma
  • endometrial clear cell carcinoma
  • psychosocial effects of cancer and its treatment
  • Endometrial Neoplasms
  • Sarcoma, Endometrial Stromal
  • Adenoma

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
University of Texas - MD Anderson Cancer CenterHouston, Texas  77030-4009
University of Alabama Comprehensive Cancer CenterBirmingham, Alabama  35294
Jonsson Comprehensive Cancer Center, UCLALos Angeles, California  90095-1781
USC/Norris Comprehensive Cancer CenterLos Angeles, California  90033-0800
Chao Family Comprehensive Cancer CenterOrange, California  92868
Stanford University Medical CenterStanford, California  94305-5408
University of Colorado Cancer CenterDenver, Colorado  80262
Vincent T. Lombardi Cancer Research Center, Georgetown UniversityWashington, District of Columbia  20007
Walter Reed Army Medical CenterWashington, District of Columbia  20307-5000
H. Lee Moffitt Cancer Center and Research InstituteTampa, Florida  33612
Emory University Hospital - AtlantaAtlanta, Georgia  30322
MBCCOP - HawaiiHonolulu, Hawaii  96813
Rush-Presbyterian-St. Luke's Medical CenterChicago, Illinois  60612
University of Chicago Cancer Research CenterChicago, Illinois  60637
Indiana University Cancer CenterIndianapolis, Indiana  46202-5265
University of Iowa Hospitals and ClinicsIowa City, Iowa  52242
Albert B. Chandler Medical Center, University of KentuckyLexington, Kentucky  40536-0084
Johns Hopkins Oncology CenterBaltimore, Maryland  21287
University of Massachusetts Memorial Medical CenterWorcester, Massachusetts  01655
CCOP - Ann Arbor RegionalAnn Arbor, Michigan  48106
Barbara Ann Karmanos Cancer InstituteDetroit, Michigan  48201
University of Minnesota Cancer CenterMinneapolis, Minnesota  55455
University of Mississippi Medical CenterJackson, Mississippi  39216-4505
Washington University School of MedicineSaint Louis, Missouri  63110
Cooper Hospital/University Medical CenterCamden, New Jersey  08103
Cancer Center of Albany Medical CenterAlbany, New York  12208
State University of New York Health Science Center at BrooklynBrooklyn, New York  11203
University of Rochester Cancer CenterRochester, New York  14642
State University of New York Health Sciences Center - Stony BrookStony Brook, New York  11790-7775
Lineberger Comprehensive Cancer Center, UNCChapel Hill, North Carolina  27599-7295
Duke Comprehensive Cancer CenterDurham, North Carolina  27710
Comprehensive Cancer Center of Wake Forest University Baptist Medical CenterWinston-Salem, North Carolina  27157-1082
Barrett Cancer Center, The University HospitalCincinnati, Ohio  45219
Cleveland Clinic Cancer CenterCleveland, Ohio  44195
Ireland Cancer CenterCleveland, Ohio  44106-5065
Arthur G. James Cancer Hospital - Ohio State UniversityColumbus, Ohio  43210
University of Oklahoma College of MedicineOklahoma City, Oklahoma  73190
Abington Memorial HospitalAbington, Pennsylvania  19001
Milton S. Hershey Medical CenterHershey, Pennsylvania  17033
Kimmel Cancer Center of Thomas Jefferson University - PhiladelphiaPhiladelphia, Pennsylvania  19107
University of Pennsylvania Cancer CenterPhiladelphia, Pennsylvania  19104
Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111
Medical University of South CarolinaCharleston, South Carolina  29425-0721
CCOP - Upstate CarolinaSpartanburg, South Carolina  29303
Simmons Cancer Center - DallasDallas, Texas  75235-9154
Cancer Center, University of Virginia HSCCharlottesville, Virginia  22908
University of Washington Medical CenterSeattle, Washington  98195-6043
Tacoma General HospitalTacoma, Washington  98405
CCOP - Greater PhoenixPhoenix, Arizona  85006-2726
Women's Cancer CenterPalo Alto, California  94304
CCOP - Atlanta RegionalAtlanta, Georgia  30342-1701
CCOP - Kansas CityKansas City, Missouri  64131
CCOP - Missouri Valley Cancer ConsortiumOmaha, Nebraska  68131
CCOP - Southern Nevada Cancer Research FoundationLas Vegas, Nevada  89106
Brookview Research, Inc.Winston-Salem, North Carolina  27103
Pennsylvania HospitalPhiladelphia, Pennsylvania  19107
CCOP - Baptist Cancer InstituteMemphis, Tennessee  38117