Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Closed	Any age	Other	NSGO-EC9501 EORTC-55991, NCT00005583

Objectives

1. 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.
2. Compare overall survival of this patient population treated with these 2 adjuvant regimens.
3. Evaluate the addition of chemotherapy to standard adjuvant radiotherapy, in terms of toxicity, in these patients.
4. Study whether the pattern of relapse in these patients is influenced by the addition of chemotherapy to adjuvant radiotherapy.

Entry 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

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

Patient Characteristics:

Age:

• Any age

Performance status:

• WHO 0-2

Life expectancy:

• Not specified

Hematopoietic:

• Adequate bone marrow function
• WBC at least 3,500/mm³
• Platelet count at least 100,000/mm³

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

Expected Enrollment

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

Outcomes

Progression-free survival
Relapse-free survival

Overall survival

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.

Hogberg T, Rosenberg P, Kristensen G, et al.: A randomized phase-III study on adjuvant treatment with radiation (RT) ± chemotherapy (CT) in early-stage high-risk endometrial cancer (NSGO-EC-9501/EORTC 55991). [Abstract] J Clin Oncol 25 (Suppl 18): A-5503, 274s, 2007.

Trial Contact Information

Trial Lead Organizations

Nordic Society for Gynaecologic Oncology

Gunnar Kristensen, MD, PhD, Protocol chair		Ph: 47-2293-4000 Email: gunnar.kristensen@klinmed.uio.no

European Organization for Research and Treatment of Cancer

Carlos de Oliveira, MD, PhD, Study coordinator		Ph: 351-239-400-500 ext. 10312 Email: de.oliveira@mail.telepac.pt

Registry Information
Official Title		A Randomized Trial of Adjuvant Treatment with Radiation Plus Chemotherapy Versus Radiation Alone in High Risk Endometrial Carcinoma
Trial Start Date		2000-01-11
Registered in ClinicalTrials.gov		NCT00005583
Date Submitted to PDQ		2000-02-07
Information Last Verified		2006-11-19

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