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

Gynecologic Oncology Group (GOG)

Status and phase

Completed

Phase 3

Conditions

Sarcoma

Treatments

Procedure: adjuvant therapy

Drug: cisplatin

Radiation: radiation therapy

Drug: ifosfamide

Study type

Interventional

Funder types

NETWORK

NIH

Identifiers

NCT00002546

GOG-0150

CDR0000063303 (Other Identifier)

NCI-2012-02226 (Other Identifier)

ECOG-G150

Details and patient eligibility

About

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.

Full description

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.

Enrollment

216 estimated patients

Sex

Female

Ages

21 to 120 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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: