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

August 1, 2013 updated by: Nordic Society of Gynaecological Oncology - Clinical Trials Unit

A Randomized Trial of Adjuvant Treatment With Radiation Plus Chemotherapy Versus Radiation Alone in High Risk Endometrial Carcinoma

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

400

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
      • Brussels, Belgium, 1000
        • Institut Jules Bordet
      • Edegem, Belgium, B-2650
        • Universitair Ziekenhuis Antwerpen
      • Kortrijk, Belgium, B-8500
        • Cazk Groeninghe - Campus Maria's Voorzienigheid
      • Leuven, Belgium, B-3000
        • U.Z. Gasthuisberg
  • France
      • Rouen, France, 76038
        • Centre Henri Becquerel
  • Ireland
      • Dublin, Ireland, 8
        • St. James's Hospital
      • Dublin, Ireland, 8
        • Coombe Women's Hospital
  • Italy
      • Naples, Italy, 80131
        • Istituto Nazionale per lo Studio e la Cura dei Tumori
      • Parma, Italy, 43100
        • Azienda Ospedaliera Di Parma
      • Pavia, Italy, 27100
        • Fondazione I.R.C.C.S. Policlinico San Matteo
      • Varese, Italy, 21100
        • Ospedale di Circolo e Fondazione Macchi
  • Netherlands
      • Amsterdam, Netherlands, 1091 HA
        • Onze Lieve Vrouwe Gasthuis
      • Enschede, Netherlands, 7500 KA
        • Medisch Spectrum Twente
      • Nijmegen, Netherlands, NL-6500 HB
        • Universitair Medisch Centrum St. Radboud - Nijmegen
  • Norway
      • Oslo, Norway, N-0310
        • Norwegian Radium Hospital
  • Poland
      • Gdansk, Poland, 80-211
        • Medical University of Gdansk
  • Portugal
      • Coimbra, Portugal, 3049
        • Hospitais da Universidade de Coimbra (HUC)
  • South Africa
      • Cape Town, South Africa, 7925
        • Groote Schuur Hospital
  • Spain
      • Madrid, Spain, 28040
        • Hospital Universitario San Carlos
      • Oviedo, Spain, 33006
        • Hospital Universitario Central de Asturias
  • United Kingdom
    • England
      • Nottingham, England, United Kingdom, NG5 1PB
        • Nottingham City Hospital NHS Trust
    • Northern Ireland
      • Belfast, Northern Ireland, United Kingdom, BT9 7AB
        • Centre for Cancer Research and Cell Biology at Belfast City Hospital
    • Scotland
      • Glasgow, Scotland, United Kingdom, G11 6NT
        • Western Infirmary

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 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

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
  • Allocation: Randomized
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Progression-free survival
Relapse-free survival

Secondary Outcome Measures

Outcome Measure
Overall survival

Collaborators and Investigators

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

Sponsor

Nordic Society of Gynaecological Oncology - Clinical Trials Unit

Collaborators

European Organisation for Research and Treatment of Cancer - EORTC

Investigators

  • Study Chair: Gunnar B. Kristensen, MD, PhD, Norwegian Radium Hospital
  • Carlos F. de Oliveira, MD, PhD, Hospitais da Universidade de Coimbra (HUC)

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

January 1, 2000

Study Completion (Actual)

July 1, 2010

Study Registration Dates

First Submitted

May 2, 2000

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Estimate)

August 2, 2013

Last Update Submitted That Met QC Criteria

August 1, 2013

Last Verified

November 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NSGO-EC9501
  • CDR0000067646 (Registry Identifier: PDQ (Physician Data Query))
  • EORTC-55991

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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