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

September 20, 2012 updated by: European Organisation for Research and Treatment of Cancer - EORTC

Phase III Randomized Study of Adjuvant Pelvic Radiotherapy Versus Observation Alone in Patients With Completely Resected, Stage I or II, High-Grade Uterine Sarcoma

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known whether receiving radiation therapy or no further therapy after surgery is more effective for cancer of the uterus.

PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with that of no further therapy in treating patients who have stage I or stage II cancer of the uterus that has been surgically removed.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

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.

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

Study Type

Interventional

Enrollment (Actual)

224

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Leuven, Belgium, B-3000
        • U.Z. Gasthuisberg
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N2
        • Tom Baker Cancer Center - Calgary
    • Quebec
      • Fleurimont, Quebec, Canada, J1H 5N4
        • CHUS-Hopital Fleurimont
  • France
      • Rouen, France, 76038
        • Centre Henri Becquerel
  • Italy
      • Brescia, Italy, 25124
        • Spedali Civili
      • Milan, Italy, 20133
        • Istituto Nazionale Per Lo Studio E La Cura Dei Tumori
      • Milano, Italy, 20132
        • Istituto Scientifico H.S. Raffaele
      • Monza, Italy, 20052
        • Ospedale San Gerardo
      • Padova, Italy, 35128
        • Universita di Padova
      • Pavia, Italy, 27100
        • I.R.C.C.S. Policlinico San Matteo
      • Varese, Italy, 21100
        • Ospedale di Circolo e Fondazione Macchi
      • Voghera (PV), Italy, 27058
        • Ospedale Civile
  • Netherlands
      • Amsterdam, Netherlands, 1001HV
        • Vrije Universiteit Medisch Centrum
      • Amsterdam, Netherlands, 1066 CX
        • Antoni van Leeuwenhoekhuis
      • Enschede, Netherlands, 7500 KA
        • Medisch Spectrum Twente
      • Heerlen, Netherlands, 6419 PC
        • Atrium Medical Centre
      • Maastricht, Netherlands, 6202 AZ
        • Academisch Ziekenhuis Maastricht
      • Nijmegen, Netherlands, NL-6252 HB
        • University Medical Center Nijmegen
      • Rotterdam, Netherlands, 3075 EA
        • Rotterdam Cancer Institute
      • Rotterdam, Netherlands, 3000 CA
        • University Hospital - Rotterdam Dijkzigt
      • Utrecht, Netherlands, 3508 GA
        • Academisch Ziekenhuis Utrecht
  • Poland
      • Gdansk, Poland, 80-211
        • Medical University of Gdansk
  • Spain
      • Valencia, Spain, 46009
        • Instituto Valenciano de Oncologia
  • Sweden
      • Linkoping, Sweden, S-581 85
        • University Hospital of Linkoping
      • Stockholm, Sweden, S-171 76
        • Karolinska Hospital
  • Switzerland
      • Geneva, Switzerland, CH-1211
        • Hopital Cantonal Universitaire de Geneva
  • United Kingdom
    • England
      • Derby, England, United Kingdom, DE1 2QY
        • Derbyshire Royal Infirmary
    • Scotland
      • Glasgow, Scotland, United Kingdom, G11 6NT
        • Beatson Oncology Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

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

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: See Disease Characteristics Radiotherapy: No prior radiotherapy Surgery: See Disease Characteristics

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

European Organisation for Research and Treatment of Cancer - EORTC

Collaborators

NCIC Clinical Trials Group

Investigators

  • Study Chair: Sergio L. Pecorelli, MD, Spedali Civili di Brescia
  • Study Chair: Gavin C.E. Stuart, MD, Tom Baker Cancer Centre - Calgary

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 1988

Primary Completion (Actual)

August 1, 2001

Study Registration Dates

First Submitted

November 1, 1999

First Submitted That Met QC Criteria

March 10, 2004

First Posted (Estimate)

March 11, 2004

Study Record Updates

Last Update Posted (Estimate)

September 24, 2012

Last Update Submitted That Met QC Criteria

September 20, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EORTC-55874
  • CAN-NCIC-EN4

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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