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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00005583
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : August 2, 2013
European Organisation for Research and Treatment of Cancer - EORTC
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Endometrial Cancer Drug: cisplatin Drug: doxorubicin hydrochloride Drug: epirubicin hydrochloride Procedure: adjuvant therapy Procedure: conventional surgery Radiation: radiation therapy Phase 3

Detailed Description:


  • 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  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Trial of Adjuvant Treatment With Radiation Plus Chemotherapy Versus Radiation Alone in High Risk Endometrial Carcinoma
Study Start Date : January 2000
Actual Study Completion Date : July 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Progression-free survival
  2. Relapse-free survival

Secondary Outcome Measures :
  1. Overall survival

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No


  • 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



  • Any age

Performance status:

  • WHO 0-2

Life expectancy:

  • Not specified


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


  • Adequate hepatic function


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


  • Adequate pulmonary function


  • 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


Biologic therapy:

  • Not specified


  • Not specified

Endocrine therapy:

  • Not specified


  • No prior preoperative irradiation


  • No prior extensive abdominal surgery

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00005583

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

Publications of Results:
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.

Other Publications: Identifier: NCT00005583     History of Changes
Other Study ID Numbers: NSGO-EC9501
CDR0000067646 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: August 2, 2013
Last Verified: November 2006

Keywords provided by National Cancer Institute (NCI):
stage I endometrial carcinoma
stage II endometrial carcinoma
endometrial adenocarcinoma
endometrial papillary serous carcinoma
endometrial clear cell carcinoma

Additional relevant MeSH terms:
Endometrial Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Diseases
Genital Diseases, Female
Liposomal doxorubicin
Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action