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A Phase III Study of Adjuvant Postoperative Irradiation With or Without Cisplatin/Taxol Chemotherapy Following TAH/BSO for Patients With Endometrial Cancer


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

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Trial Information

A Phase III Study of Adjuvant Postoperative Irradiation With or Without Cisplatin/Taxol Chemotherapy Following TAH/BSO for Patients With Endometrial Cancer


OBJECTIVES:

- Compare the relapse-free survival in patients with stage I or II endometrial cancer
treated with adjuvant radiotherapy with or without cisplatin and paclitaxel after total
abdominal hysterectomy and bilateral salpingo-oophorectomy.

- Compare the patterns of recurrence and the acute and late toxicity profiles associated
with these treatment regimens in this patient population.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
disease stage (IC-IIA vs IIB). Patients are randomized to one of two treatment arms.

- Arm I: Within 8 weeks after surgery, patients receive radiotherapy once daily 5 days a
week for 5.5 weeks.

- Arm II: Within 8 weeks after surgery, patients receive radiotherapy as in arm I
concurrently with cisplatin IV over 2-4 hours on days 1 and 28. After completion of
radiotherapy, patients receive paclitaxel IV over 3 hours followed by cisplatin IV over
2-4 hours on days 56, 84, 112, and 140.

Patients are followed every 3 months for 1 year, every 6 months for 3 years, and then
annually thereafter.

PROJECTED ACCRUAL: A total of 436 patients (218 per treatment arm) will be accrued for this
study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed uterine confined endometrioid endometrial adenocarcinoma
with one of the following:

- Grade 2 or 3 carcinoma with more than 50% myometrial invasion (stage IC and IIA)

- Grade 2 or 3 carcinoma with stromal invasion of the cervix (stage IIB)

- No grade I adenocarcinoma

- Less than 50% papillary serous or clear cell histology on pathologic specimen

- Prior hysterectomy (total abdominal, vaginal hysterectomy, or laparoscopic-assisted
vaginal hysterectomy) and bilateral salpingo-oophorectomy with or without additional
surgical staging for endometrial cancer no more than 8 weeks prior to study

- No known metastatic extrauterine metastases, known gross residual disease, positive
peritoneal cytology, or distant metastases

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- Zubrod 0-1

Life expectancy:

- Not specified

Hematopoietic:

- Absolute neutrophil count at least 1,800/mm^3

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

- Hemoglobin at least 10 g/dL

Hepatic:

- Bilirubin no greater than 1.5 times normal

- SGOT no greater than 3 times normal

Renal:

- Creatinine no greater than 1.5 mg/dL

Cardiovascular:

- No cardiac dysrhythmias

Other:

- No other malignancy within the past 5 years except nonmelanomatous skin cancer

- No medical contraindications to study therapy

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- No prior chemotherapy

Endocrine therapy:

- Not specified

Radiotherapy:

- No prior radiotherapy

Surgery:

- See Disease Characteristics

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Kathryn M. Greven, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Comprehensive Cancer Center of Wake Forest University

Authority:

United States: Federal Government

Study ID:

CDR0000068040

NCT ID:

NCT00006027

Start Date:

August 2000

Completion Date:

Related Keywords:

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

Name

Location

Fred Hutchinson Cancer Research CenterSeattle, Washington  98109
Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
Jonsson Comprehensive Cancer Center, UCLALos Angeles, California  90095-1781
MBCCOP - HawaiiHonolulu, Hawaii  96813
Indiana University Cancer CenterIndianapolis, Indiana  46202-5265
University of Minnesota Cancer CenterMinneapolis, Minnesota  55455
University of Mississippi Medical CenterJackson, Mississippi  39216-4505
State University of New York Health Science Center at BrooklynBrooklyn, New York  11203
Lineberger Comprehensive Cancer Center, UNCChapel Hill, North Carolina  27599-7295
Duke Comprehensive Cancer CenterDurham, North Carolina  27710
University of Oklahoma College of MedicineOklahoma City, Oklahoma  73190
Tacoma General HospitalTacoma, Washington  98405
Penn State Cancer Institute at Milton S. Hershey Medical CenterHershey, Pennsylvania  17033-0850
Community Hospital of Los GatosLos Gatos, California  95032
Comprehensive Cancer Center at Wake Forest UniversityWinston-Salem, North Carolina  27157-1082
Brookview Research, Inc.Nashville, Tennessee  37203
University of Texas Medical BranchGalveston, Texas  77555-1329
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
Holden Comprehensive Cancer Center at University of IowaIowa City, Iowa  52242-1002
Ellis Fischel Cancer Center at University of Missouri - ColumbiaColumbia, Missouri  65203
Long Island Cancer Center at Stony Brook University HospitalStony Brook, New York  11790-7775
Kimmel Cancer Center at Thomas Jefferson University - PhiladelphiaPhiladelphia, Pennsylvania  19107
Cooper University HospitalCamden, New Jersey  08103
Tufts - New England Medical CenterBoston, Massachusetts  02111
Hollings Cancer Center at Medical University of South CarolinaCharleston, South Carolina  29425
CCOP - Marshfield Clinic Research FoundationMarshfield, Wisconsin  54449
Warren Grant Magnuson Clinical Center - NCI Clinical Studies SupportBethesda, Maryland  20892-1182