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

This study has been completed.
Sponsor:
Collaborator:
European Organisation for Research and Treatment of Cancer - EORTC
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00005583
First received: May 2, 2000
Last updated: August 1, 2013
Last verified: November 2006
  Purpose

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 Intervention Phase
Endometrial Cancer
Drug: cisplatin
Drug: doxorubicin hydrochloride
Drug: epirubicin hydrochloride
Procedure: adjuvant therapy
Procedure: conventional surgery
Radiation: radiation therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: 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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Progression-free survival [ Designated as safety issue: No ]
  • Relapse-free survival [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival [ Designated as safety issue: No ]

Estimated Enrollment: 400
Study Start Date: January 2000
Study Completion Date: July 2010
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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00005583

Locations
Belgium
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
France
Centre Henri Becquerel
Rouen, France, 76038
Ireland
Coombe Women's Hospital
Dublin, Ireland, 8
St. James's Hospital
Dublin, Ireland, 8
Italy
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
Netherlands
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
Norway
Norwegian Radium Hospital
Oslo, Norway, N-0310
Poland
Medical University of Gdansk
Gdansk, Poland, 80-211
Portugal
Hospitais da Universidade de Coimbra (HUC)
Coimbra, Portugal, 3049
South Africa
Groote Schuur Hospital
Cape Town, South Africa, 7925
Spain
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
Investigators
Study Chair: Gunnar B. Kristensen, MD, PhD Norwegian Radium Hospital
Investigator: Carlos F. de Oliveira, MD, PhD Hospitais da Universidade de Coimbra (HUC)
  More Information

Additional Information:
Publications:
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.

ClinicalTrials.gov Identifier: NCT00005583     History of Changes
Other Study ID Numbers: NSGO-EC9501, CDR0000067646, EORTC-55991
Study First Received: May 2, 2000
Last Updated: August 1, 2013
Health Authority: United States: Federal Government

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:
Doxorubicin
Epirubicin
Liposomal doxorubicin
Antibiotics, Antineoplastic
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Topoisomerase II Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on October 21, 2014