Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

Summary

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether radiation therapy is more effective than combination chemotherapy in treating patients with cancer of the uterus.

PURPOSE: This randomized phase III trial is studying radiation therapy to see how well it works compared to combination chemotherapy in treating patients with cancer of the uterus.

Further Study Information

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 5 days a week for 2.2 weeks.

• Arm II: Patients receive cisplatin IV followed by ifosfamide IV over 1 hour on days 1-4. Treatment continues every 3 weeks for 3 courses.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 216 patients will be accrued for this study within 6 years.

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 Contact Information

Trial Lead Organizations/Sponsors

Gynecologic Oncology Group

Aaron H. Wolfson

Study Chair

Higinia R. Cardenes

Study Chair

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00002546
Information obtained from ClinicalTrials.gov on November 20, 2012

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