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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
Not Enrolling
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


- 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

Inclusion Criteria


- 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



- 18 and over

Performance status:

- Zubrod 0-1

Life expectancy:

- Not specified


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

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

- Hemoglobin at least 10 g/dL


- Bilirubin no greater than 1.5 times normal

- SGOT no greater than 3 times normal


- Creatinine no greater than 1.5 mg/dL


- No cardiac dysrhythmias


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

- No medical contraindications to study therapy


Biologic therapy:

- Not specified


- No prior chemotherapy

Endocrine therapy:

- Not specified


- No prior radiotherapy


- See Disease Characteristics

Type of Study:


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


United States: Federal Government

Study ID:




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



Fred Hutchinson Cancer Research Center Seattle, Washington  98109
Memorial Sloan-Kettering Cancer Center New York, New York  10021
Jonsson Comprehensive Cancer Center, UCLA Los Angeles, California  90095-1781
MBCCOP - Hawaii Honolulu, Hawaii  96813
Indiana University Cancer Center Indianapolis, Indiana  46202-5265
University of Minnesota Cancer Center Minneapolis, Minnesota  55455
University of Mississippi Medical Center Jackson, Mississippi  39216-4505
State University of New York Health Science Center at Brooklyn Brooklyn, New York  11203
Lineberger Comprehensive Cancer Center, UNC Chapel Hill, North Carolina  27599-7295
Duke Comprehensive Cancer Center Durham, North Carolina  27710
University of Oklahoma College of Medicine Oklahoma City, Oklahoma  73190
Tacoma General Hospital Tacoma, Washington  98405
Penn State Cancer Institute at Milton S. Hershey Medical Center Hershey, Pennsylvania  17033-0850
Community Hospital of Los Gatos Los Gatos, California  95032
Comprehensive Cancer Center at Wake Forest University Winston-Salem, North Carolina  27157-1082
Brookview Research, Inc. Nashville, Tennessee  37203
University of Texas Medical Branch Galveston, Texas  77555-1329
Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center Orange, California  92868
University of Colorado Cancer Center at University of Colorado Health Sciences Center Denver, Colorado  80010
Holden Comprehensive Cancer Center at University of Iowa Iowa City, Iowa  52242-1002
Ellis Fischel Cancer Center at University of Missouri - Columbia Columbia, Missouri  65203
Long Island Cancer Center at Stony Brook University Hospital Stony Brook, New York  11790-7775
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia Philadelphia, Pennsylvania  19107
Cooper University Hospital Camden, New Jersey  08103
Tufts - New England Medical Center Boston, Massachusetts  02111
Hollings Cancer Center at Medical University of South Carolina Charleston, South Carolina  29425
CCOP - Marshfield Clinic Research Foundation Marshfield, Wisconsin  54449
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support Bethesda, Maryland  20892-1182