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

Alternate Title

Radiation Therapy or No Further Treatment Following Surgery in Treating Patients With Cancer of the Uterus

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Closed	Any age	Other	EORTC-55874 CAN-NCIC-EN4, NCT00002459, EN4

Objectives

I. Compare the rates of pelvic recurrence and development of distant 
metastases in patients with completely resected, stage I or II, high-grade 
uterine sarcoma treated with adjuvant pelvic radiotherapy vs observation alone.

Entry Criteria

Disease Characteristics:

Histologically proven high-grade uterine sarcoma
 Eligible subtypes:
  Leiomyosarcoma 
  Mixed mesodermal (mullerian) sarcoma
  Endometrial sarcoma
 Surgically proven stage I or II (T1-2, N0, M0) disease 

No leiomyoma with a high mitotic activity index after hormonal therapy
(especially estrogen)

Mixoid leiomyosarcoma with a low mitotic activity index allowed

Completely resected disease 
 Prior abdominal hysterectomy as minimal surgical procedure required

Prior/Concurrent Therapy:

Biologic therapy:
 Not specified

Chemotherapy:
 Not specified

Endocrine therapy:
 See Disease Characteristics

Radiotherapy:
 No prior radiotherapy

Surgery:
 See Disease Characteristics

Patient Characteristics:

Age:
 Any age

Performance status:
 WHO 0-2

Life expectancy:
 Not specified

Hematopoietic:
 Not specified

Hepatic:
 Not specified

Renal:
 Not specified

Other:
 No other prior malignancy except basal cell skin cancer or carcinoma in situ
  of the cervix
 No serious mental disorder

Expected Enrollment

A total of 200 patients (100 per arm) will be accrued for this study within 3 
years.

Outline

This is a randomized, multicenter study. Patients are stratified according to 
center, tumor histology (leiomyosarcoma vs mixed mesodermal sarcoma vs 
endometrial stromal sarcoma), and surgical procedure (total abdominal 
hysterectomy (TAH) with or without bilateral salpingo-oophorectomy (BSO) vs 
TAH and BSO with pelvic and para-aortic node sampling and random biopsies). 
Patients are randomized to 1 of 2 treatment arms.

Arm I: Beginning within 6 weeks after surgery, patients undergo pelvic 
radiotherapy 5 days a week for 5.6 weeks.

Arm II: Patients undergo observation alone.

Patients are followed every 2 months for 1 year, every 3 months for 2 years, 
and then every 6 months thereafter.

Reed NS, Mangioni C, Malmström H, et al.: Phase III randomised study to evaluate the role of adjuvant pelvic radiotherapy in the treatment of uterine sarcomas stages I and II: an European Organisation for Research and Treatment of Cancer Gynaecological Cancer Group Study (protocol 55874). Eur J Cancer 44 (6): 808-18, 2008.[PUBMED Abstract]

Reed NS, Mangioni C, Malmstrom H, et al.: First results of a randomised trial comparing radiotherapy versus observation post operatively in patients with uterine sarcomas. An EORTC-GCG study. [Abstract] Int J Gynecol Cancer 13 (Suppl 1): A-PL12, 4, 2003.

Trial Contact Information

Trial Lead Organizations

European Organization for Research and Treatment of Cancer

Sergio Pecorelli, MD, Protocol chair		Ph: 39-030-399-5341 Email: pecorell@med.unibs.it

NCIC-Clinical Trials Group

Gavin Stuart, MD, Protocol chair		Ph: 403-944-1721 Email: gavinst@cancerboard.ab.ca

Registry Information
Official Title		Phase III Randomized Study of Adjuvant Pelvic Radiotherapy Versus Observation Alone in Patients With Completely Resected, Stage I or II, High-Grade Uterine Sarcoma
Trial Start Date		1988-04-01
Registered in ClinicalTrials.gov		NCT00002459
Date Submitted to PDQ		1988-04-01
Information Last Verified		2008-07-11