Know Cancer

or
forgot password

A Randomized Phase III Study of Tumor Volume Directed Pelvic Plus or Minus Para-Aortic Irradiation Followed by Cisplatin and Doxorubicin or Cisplatin, Doxorubicin and Paclitaxel for Advanced Endometrial Carcinoma


Phase 3
N/A
N/A
Not Enrolling
Female
Endometrial Cancer

Thank you

Trial Information

A Randomized Phase III Study of Tumor Volume Directed Pelvic Plus or Minus Para-Aortic Irradiation Followed by Cisplatin and Doxorubicin or Cisplatin, Doxorubicin and Paclitaxel for Advanced Endometrial Carcinoma


OBJECTIVES:

- Compare survival and progression-free survival in patients with stage III endometrial
carcinoma treated with tumor volume-directed pelvic radiotherapy with or without
paraaortic radiotherapy followed by cisplatin and doxorubicin with or without
paclitaxel.

- Compare short and long-term toxic effects of these treatment regimens in this patient
population.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
radiotherapy field (pelvic vs extended field).

Within 8 weeks after surgery, patients receive tumor volume-directed pelvic radiotherapy
with or without paraaortic nodal radiotherapy once daily for 5 consecutive days for up to 16
weeks after surgery.

Within 8 weeks of completing radiotherapy, patients are randomized to 1 of 2 chemotherapy
treatment arms.

- Arm I: Patients receive doxorubicin IV over 30 minutes immediately followed by
cisplatin IV over 1 hour on day 1. Patients also receive filgrastim (G-CSF)
subcutaneously (SC) or pegfilgrastim on days 2-11.

- Arm II: Patients receive doxorubicin and cisplatin as in arm I, paclitaxel IV over 3
hours on day 2, and G-CSF SC or pegfilgrastim on days 3-12.

Treatment repeats every 3 weeks for a maximum of 6 courses in the absence of disease
progression or unacceptable toxicity.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then
annually thereafter.

PROJECTED ACCRUAL: A total of 614 patients (307 per treatment arm) will be accrued for this
study within 5.2 years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed advanced endometrial carcinoma with any histology,
including:

- Clear cell and serous papillary carcinoma

- Surgical stage III disease, including:

- Positive adnexa

- Tumor invading the serosa

- Positive pelvic and/or paraaortic nodes

- Involvement of bowel mucosa

- Intraabdominal metastases

- Positive pelvic washings

- Vaginal involvement within the radiation port

- Must have had prior surgery, including hysterectomy and bilateral
salpingo-oophorectomy

- Tumor maximally debulked to a maximum residual diameter of no greater than 2 cm

- Paraaortic lymph node sampling allowed

- If positive, must have negative chest CT scan

- No recurrent disease

- No parenchymal liver metastases

- No disease outside the abdomen

PATIENT CHARACTERISTICS:

Age:

- Not specified

Performance status:

- GOG 0-2

Life expectancy:

- At least 3 months

Hematopoietic:

- Absolute neutrophil count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3

Hepatic:

- Bilirubin no greater than 1.5 times normal

- SGOT/SGPT no greater than 3 times normal

- Alkaline phosphatase no greater than 3 times normal

Renal:

- Creatinine no greater than 1.6 mg/dL

Cardiovascular:

- LVEF at least 50% within 6 months of study entry

Other:

- No other prior or concurrent malignancy within the past 5 years except adequately
treated nonmelanoma skin cancer

- No serious comorbid illness that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- No prior chemotherapy

Endocrine therapy:

- Not specified

Radiotherapy:

- See Disease Characteristics

- No prior pelvic or abdominal radiotherapy

- No prior radiotherapy for prior malignancy

Surgery:

- See Disease Characteristics

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Howard D. Homesley, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Gynecologic Oncology Network

Authority:

United States: Federal Government

Study ID:

CDR0000068020

NCT ID:

NCT00006011

Start Date:

July 2000

Completion Date:

Related Keywords:

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

Name

Location

Fred Hutchinson Cancer Research CenterSeattle, Washington  98109
Mayo Clinic Cancer CenterRochester, Minnesota  55905
Jonsson Comprehensive Cancer Center, UCLALos Angeles, California  90095-1781
Walter Reed Army Medical CenterWashington, District of Columbia  20307-5000
University of Chicago Cancer Research CenterChicago, Illinois  60637
Indiana University Cancer CenterIndianapolis, Indiana  46202-5265
Barbara Ann Karmanos Cancer InstituteDetroit, Michigan  48201
University of Minnesota Cancer CenterMinneapolis, Minnesota  55455
University of Mississippi Medical CenterJackson, Mississippi  39216-4505
Duke Comprehensive Cancer CenterDurham, North Carolina  27710
University of Oklahoma College of MedicineOklahoma City, Oklahoma  73190
Abington Memorial HospitalAbington, Pennsylvania  19001
CCOP - Kansas CityKansas City, Missouri  64131
CCOP - Missouri Valley Cancer ConsortiumOmaha, Nebraska  68131
CCOP - Southern Nevada Cancer Research FoundationLas Vegas, Nevada  89106
CCOP - Christiana Care Health ServicesWilmington, Delaware  19899
CCOP - Carle Cancer CenterUrbana, Illinois  61801
CCOP - KalamazooKalamazoo, Michigan  49007-3731
CCOP - Metro-MinnesotaSaint Louis Park, Minnesota  55416
CCOP - Michigan Cancer Research ConsortiumAnn Arbor, Michigan  48106
Penn State Cancer Institute at Milton S. Hershey Medical CenterHershey, Pennsylvania  17033-0850
Medical College of Wisconsin Cancer CenterMilwaukee, Wisconsin  53226
University of Alabama at Birmingham Comprehensive Cancer CenterBirmingham, Alabama  35294-3300
Comprehensive Cancer Center at Wake Forest UniversityWinston-Salem, North Carolina  27157-1082
Cancer Center at the University of VirginiaCharlottesville, Virginia  22908
NYU School of Medicine's Kaplan Comprehensive Cancer CenterNew York, New York  10016
CCOP - Central IllinoisSpringfield, Illinois  62526
CCOP - Cancer Research for the OzarksSpringfield, Missouri  65807
CCOP - MainLine HealthWynnewood, Pennsylvania  19096
University of Texas Medical BranchGalveston, Texas  77555-1329
University of Wisconsin Comprehensive Cancer CenterMadison, Wisconsin  53792
CCOP - Western Regional, ArizonaPhoenix, Arizona  85006-2726
Chao Family Comprehensive Cancer Center at University of California Irvine Cancer CenterOrange, California  92868
University of Colorado Cancer Center at University of Colorado Health Sciences CenterDenver, Colorado  80010
MBCCOP - University of Illinois at ChicagoChicago, Illinois  60612
Rush University Medical CenterChicago, Illinois  60612-3824
CCOP - EvanstonEvanston, Illinois  60201
Saint Joseph Regional Medical CenterSouth Bend, Indiana  46617
Holden Comprehensive Cancer Center at University of IowaIowa City, Iowa  52242-1002
CCOP - Grand RapidsGrand Rapids, Michigan  49503
Ellis Fischel Cancer Center at University of Missouri - ColumbiaColumbia, Missouri  65203
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical CenterLebanon, New Hampshire  03756-0002
MBCCOP - University of New Mexico HSCAlbuquerque, New Mexico  87131
Long Island Cancer Center at Stony Brook University HospitalStony Brook, New York  11790-7775
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel HillChapel Hill, North Carolina  27599-7570
Charles M. Barrett Cancer Center at University HospitalCincinnati, Ohio  45267-0526
MetroHealth's Cancer Care Center at MetroHealth Medical CenterCleveland, Ohio  44106
CCOP - Columbia River Oncology ProgramPortland, Oregon  97225
CCOP - Geisinger Clinic and Medical CenterDanville, Pennsylvania  17822-2001
Kimmel Cancer Center at Thomas Jefferson University - PhiladelphiaPhiladelphia, Pennsylvania  19107
UPMC Cancer Center at Magee-Womens HospitalPittsburgh, Pennsylvania  15213-3180
Southeast Gynecologic Oncology AssociatesKnoxville, Tennessee  37917
Vanderbilt-Ingram Cancer Center at Vanderbilt Medical CenterNashville, Tennessee  37232-2516
CCOP - Scott and White HospitalTemple, Texas  76508
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimore, Maryland  21231-2410
CCOP - St. Vincent Hospital Cancer Center, Green BayGreen Bay, Wisconsin  54301
University of Massachusetts Memorial Medical Center - University CampusWorcester, Massachusetts  01655
Cooper University HospitalCamden, New Jersey  08103
Markey Cancer Center at University of Kentucky Chandler Medical CenterLexington, Kentucky  40536-0084
Tufts - New England Medical CenterBoston, Massachusetts  02111
Fletcher Allen Health Care - Medical Center CampusBurlington, Vermont  05401
Arthur G. James Cancer Hospital at Ohio State UniversityColumbus, Ohio  43210-1240
Cancer Institute of New Jersey at Robert Wood Johnson University HospitalNew Brunswick, New Jersey  08903
Warren Grant Magnuson Clinical Center - NCI Clinical Studies SupportBethesda, Maryland  20892-1182
Gynecologic Oncology NetworkNashville, Tennessee  37203
CCOP - Mayo Clinic Scottsdale Oncology ProgramScottsdale, Arizona  85259
Siteman Cancer CenterSaint Louis, Missouri  63110
Abramson Cancer Center of the University of Pennsylvania Medical CenterPhiladelphia, Pennsylvania  19104-4283
Women's Cancer Center at Community Hospital of Los GatosLos Gatos, California  95032
Multicare Medical CenterTacoma, Washington  98405