Radiation Therapy Compared With Combination Chemotherapy in Treating Patients With Cancer of the Uterus
Launched by GYNECOLOGIC ONCOLOGY GROUP · Jan 26, 2003
Trial Information
Current as of July 15, 2025
Completed
Keywords
ClinConnect Summary
OBJECTIVES:
* Compare the survival, progression-free interval, and failure patterns in patients with optimally debulked stage I-IV carcinosarcoma of the uterus treated with whole abdominal radiotherapy vs ifosfamide and cisplatin.
* Compare the incidence and type of acute and late adverse events observed with these treatment regimens in this patient population.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to one of two treatment arms.
* Arm I: Patients receive whole abdominal radiotherapy 5 days a week for 4 weeks, followed by radiotherapy boost to the pelvis...
Gender
FEMALE
Eligibility criteria
- DISEASE CHARACTERISTICS:
- • Histologically confirmed primary homologous or heterologous carcinosarcoma of the uterus (corpus and cervix)
- • Surgical stage I-IV disease, including positive adnexa, tumor invading the serosa, positive pelvic and/or para-aortic nodes, involvement of the mucosa of the bowel, bladder, or rectum, intra-abdominal metastases, positive pelvic washings, or vaginal involvement within planned radiation port
- • Prior total abdominal hysterectomy with bilateral salpingo-oophorectomy and maximum tumor resection of all gross intra-abdominal/pelvic disease, including grossly involved pelvic and para-aortic nodes within 8 weeks before study
- • No greater than 1 cm residual disease
- • Cervical sarcomas also allowed
- * No metastasis beyond the abdominal cavity at diagnosis, including the following:
- • Parenchymal liver metastasis
- • Lung metastasis
- • Positive inguinal lymph nodes
- • Positive scalene nodes
- • Radiographic or pathologic evidence of bone or brain metastasis
- PATIENT CHARACTERISTICS:
- Age:
- • 21 and over
- Performance status:
- • GOG 0-2
- Hematopoietic:
- • WBC at least 3,000/mm3
- • Granulocyte count at least 1,500/mm3
- • Platelet count at least 100,000/mm3
- Hepatic:
- • Bilirubin no greater than 1.5 times normal
- • SGOT no greater than 3 times normal
- • Albumin at least 3 g/dL
- • No acute hepatitis
- Renal:
- • Creatinine no greater than 1.5 mg/dL OR
- • Creatinine clearance at least 50 mL/min
- Other:
- • No septicemia
- • No severe infection
- • No severe gastrointestinal bleeding
- • No prior invasive or concurrent malignancy within the past 5 years except nonmelanoma skin cancer
- PRIOR CONCURRENT THERAPY:
- Biologic therapy:
- • Not specified
- Chemotherapy:
- • No prior chemotherapy
- Endocrine therapy:
- • Prior hormonal therapy allowed
- Radiotherapy:
- • See Disease Characteristics
- • No prior radiotherapy
- Surgery:
- • See Disease Characteristics
- Other:
- • No prior therapy that would preclude study therapy
About Gynecologic Oncology Group
The Gynecologic Oncology Group (GOG) is a leading clinical trial sponsor dedicated to advancing the understanding and treatment of gynecologic cancers. Comprising a network of experts in the field, GOG conducts rigorous, multi-institutional research to evaluate innovative therapeutic strategies and improve patient outcomes. Through its commitment to high-quality clinical trials, the organization aims to enhance the standard of care for women diagnosed with gynecologic malignancies, fostering collaborations with academic institutions and industry partners to translate scientific discoveries into effective treatments. GOG's mission emphasizes patient safety, ethical research practices, and the dissemination of findings to benefit the broader medical community.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Seattle, Washington, United States
New York, New York, United States
Washington, District Of Columbia, United States
Chicago, Illinois, United States
Indianapolis, Indiana, United States
Detroit, Michigan, United States
Minneapolis, Minnesota, United States
Jackson, Mississippi, United States
Durham, North Carolina, United States
Oklahoma City, Oklahoma, United States
Abington, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Kansas City, Missouri, United States
Omaha, Nebraska, United States
Las Vegas, Nevada, United States
Urbana, Illinois, United States
Kalamazoo, Michigan, United States
Saint Louis Park, Minnesota, United States
Pretoria, , South Africa
Ann Arbor, Michigan, United States
Hershey, Pennsylvania, United States
Birmingham, Alabama, United States
Winston Salem, North Carolina, United States
Charlottesville, Virginia, United States
Springfield, Missouri, United States
Galveston, Texas, United States
Phoenix, Arizona, United States
Los Gatos, California, United States
Orange, California, United States
Denver, Colorado, United States
Newark, Delaware, United States
Miami, Florida, United States
Chicago, Illinois, United States
Chicago, Illinois, United States
Decatur, Illinois, United States
Evanston, Illinois, United States
Hinsdale, Illinois, United States
South Bend, Indiana, United States
South Bend, Indiana, United States
Iowa City, Iowa, United States
Boston, Massachusetts, United States
Worcester, Massachusetts, United States
Grand Rapids, Michigan, United States
Keesler Afb, Mississippi, United States
Columbia, Missouri, United States
Saint Louis, Missouri, United States
Lebanon, New Hampshire, United States
Camden, New Jersey, United States
Albuquerque, New Mexico, United States
Stony Brook, New York, United States
Chapel Hill, North Carolina, United States
Greenville, North Carolina, United States
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
Columbus, Ohio, United States
Portland, Oregon, United States
Danville, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Knoxville, Tennessee, United States
Nashville, Tennessee, United States
Temple, Texas, United States
Burlington, Vermont, United States
Tacoma, Washington, United States
Patients applied
Trial Officials
Aaron H. Wolfson, MD
Study Chair
University of Miami Sylvester Comprehensive Cancer Center
Higinia R. Cardenes, MD, PhD
Study Chair
Indiana University Melvin and Bren Simon Cancer Center
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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