Radiation Therapy With or Without Chemotherapy in Treating Patients With High-Risk Endometrial Cancer

Nordic Society of Gynaecological Oncology - Clinical Trials Unit

Status and phase: Completed; Phase 3

Conditions: Endometrial Cancer

Treatments: Drug: epirubicin hydrochloride; Procedure: conventional surgery; Drug: doxorubicin hydrochloride; Radiation: radiation therapy; Drug: cisplatin; Procedure: adjuvant therapy

Study type: Interventional

Funder types: Other; NETWORK

Identifiers

NCT00005583

EORTC-55991

CDR0000067646 (Registry Identifier)

NSGO-EC9501

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 with chemotherapy is more effective than radiation therapy alone in treating high-risk endometrial cancer.

PURPOSE: This randomized phase III trial is studying radiation therapy and chemotherapy to see how well they work compared to radiation therapy alone in treating patients with high-risk endometrial cancer.

Full description

OBJECTIVES:

• Compare relapse-free survival of patients with high-risk endometrial carcinoma treated in the adjuvant setting with either radiotherapy alone or radiotherapy and chemotherapy given sequentially.
• Compare overall survival of this patient population treated with these 2 adjuvant regimens.
• Evaluate the addition of chemotherapy to standard adjuvant radiotherapy, in terms of toxicity, in these patients.
• Study whether the pattern of relapse in these patients is influenced by the addition of chemotherapy to adjuvant radiotherapy.

OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to center and histologic type (serous papillary and clear cell vs all other types). Patients are randomized to 1 of 2 treatment arms.

All patients undergo hysterectomy with bilateral salpingooophorectomy and extirpation of macroscopic suspicious lymph nodes.

• Arm I: Within 7 weeks after surgery, patients begin radiotherapy.
• Arm II: Patients receive radiotherapy followed by or preceded by chemotherapy*. Patients receive cisplatin IV over 60 minutes and doxorubicin or epirubicin IV over 10-20 minutes on day 1. Treament repeats every 21 days for 4 courses.

NOTE: *If radiotherapy is preceded by chemotherapy, radiotherapy begins within 4 weeks after chemotherapy.

Patients are followed at 3 and 6 months and then every 6 months for 5 years.

PROJECTED ACCRUAL: A total of 400 patients (200 per treatment arm) will be accrued for this study within 5 years.

Enrollment: 400 estimated patients

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed endometrial cancer of 1 of the following types:

  • Clear cell carcinoma
  • Serous papillary carcinoma
  • Undifferentiated (anaplastic) carcinoma
  • Poorly differentiated (FIGO grade 3) adenocarcinoma with infiltration to more than half the myometrial thickness

• No small cell carcinoma with neuroendocrine differentiation

• Primary in FIGO surgical stage I or occult stage II

• No spread of disease outside the uterine corpus except to pelvic lymph nodes

  • No spread of disease to para-aortic lymph nodes

• Positive peritoneal washings allowed

• No preoperative macroscopic tumor involvement of the cervix

  • Microscopic tumor involvement of the cervix on histopathological evaluation of the operative uterine specimen allowed

PATIENT CHARACTERISTICS:

Age:

• Any age

Performance status:

• WHO 0-2

Life expectancy:

• Not specified

Hematopoietic:

• Adequate bone marrow function
• WBC at least 3,500/mm^3
• Platelet count at least 100,000/mm^3

Hepatic:

• Adequate hepatic function

Renal:

• Adequate renal function
• Creatinine no greater than 1.4 mg/dL

Pulmonary:

• Adequate pulmonary function

Other:

• Not pregnant or nursing
• Fit to receive combination chemotherapy
• No other malignancy except basal cell or squamous cell skin cancer
• No uncontrolled or potentially active site of infection (e.g., fistula or abscesses)
• No other concurrent condition that would produce a substantial increase in risk for complications from radiotherapy
• No other concurrent condition that would interfere with adequate follow-up

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• Not specified

Endocrine therapy:

• Not specified

Radiotherapy:

• No prior preoperative irradiation

Surgery:

• No prior extensive abdominal surgery