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

Launched by GYNECOLOGIC ONCOLOGY GROUP · Jan 26, 2003

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