Comparison of Radiation Therapy With or Without Combination Chemotherapy Following Surgery in Treating Patients With Stage I or Stage II Endometrial Cancer
NCT ID: NCT00006027
Last Updated: 2020-10-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
INTERVENTIONAL
2000-08-31
Brief Summary
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PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with or without combination chemotherapy following surgery in treating patients who have stage I or stage II endometrial cancer.
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Detailed Description
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* 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.
Conditions
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Study Design
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RANDOMIZED
TREATMENT
Interventions
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cisplatin
paclitaxel
adjuvant therapy
radiation therapy
Eligibility Criteria
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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
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
18 Years
120 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
Gynecologic Oncology Group
NETWORK
Radiation Therapy Oncology Group
NETWORK
Responsible Party
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Principal Investigators
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Kathryn M. Greven, MD
Role: STUDY_CHAIR
Wake Forest University Health Sciences
Richard R. Barakat, MD
Role: STUDY_CHAIR
Memorial Sloan Kettering Cancer Center
Locations
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Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States
Community Hospital of Los Gatos
Los Gatos, California, United States
Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center
Orange, California, United States
University of Colorado Cancer Center at University of Colorado Health Sciences Center
Denver, Colorado, United States
MBCCOP - Hawaii
Honolulu, Hawaii, United States
Indiana University Cancer Center
Indianapolis, Indiana, United States
Holden Comprehensive Cancer Center at University of Iowa
Iowa City, Iowa, United States
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, United States
Tufts - New England Medical Center
Boston, Massachusetts, United States
University of Minnesota Cancer Center
Minneapolis, Minnesota, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
Ellis Fischel Cancer Center at University of Missouri - Columbia
Columbia, Missouri, United States
Cooper University Hospital
Camden, New Jersey, United States
State University of New York Health Science Center at Brooklyn
Brooklyn, New York, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
Long Island Cancer Center at Stony Brook University Hospital
Stony Brook, New York, United States
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, United States
Duke Comprehensive Cancer Center
Durham, North Carolina, United States
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, United States
University of Oklahoma College of Medicine
Oklahoma City, Oklahoma, United States
Penn State Cancer Institute at Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, United States
Hollings Cancer Center at Medical University of South Carolina
Charleston, South Carolina, United States
Brookview Research, Inc.
Nashville, Tennessee, United States
University of Texas Medical Branch
Galveston, Texas, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States
Tacoma General Hospital
Tacoma, Washington, United States
CCOP - Marshfield Clinic Research Foundation
Marshfield, Wisconsin, United States
Norwegian Radium Hospital
Oslo, , Norway
Countries
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Other Identifiers
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CDR0000068040
Identifier Type: -
Identifier Source: secondary_id
GOG-0194
Identifier Type: -
Identifier Source: secondary_id
RTOG-9905
Identifier Type: -
Identifier Source: org_study_id
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