Radiation Therapy Compared With Combination Chemotherapy in Treating Patients With Cancer of the Uterus

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.

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