Search / Trial NCT00002546

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 December 26, 2024

Completed

Keywords

Stage I Uterine Sarcoma Stage Ii Uterine Sarcoma Stage Iii Uterine Sarcoma Stage Iv Uterine Sarcoma Uterine Carcinosarcoma

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

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

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.

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

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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