- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00005583
Radiation Therapy With or Without Chemotherapy in Treating Patients With High-Risk Endometrial Cancer
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
Conditions
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
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Brussels, Belgium, 1000
- Institut Jules Bordet
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Edegem, Belgium, B-2650
- Universitair Ziekenhuis Antwerpen
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Kortrijk, Belgium, B-8500
- Cazk Groeninghe - Campus Maria's Voorzienigheid
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Leuven, Belgium, B-3000
- U.Z. Gasthuisberg
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Rouen, France, 76038
- Centre Henri Becquerel
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Dublin, Ireland, 8
- St. James's Hospital
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Dublin, Ireland, 8
- Coombe Women's Hospital
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Naples, Italy, 80131
- Istituto Nazionale Per Lo Studio E La Cura Dei Tumori
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Parma, Italy, 43100
- Azienda Ospedaliera Di Parma
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Pavia, Italy, 27100
- Fondazione I.R.C.C.S. Policlinico San Matteo
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Varese, Italy, 21100
- Ospedale Di Circolo E Fondazione Macchi
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Amsterdam, Netherlands, 1091 HA
- Onze Lieve Vrouwe Gasthuis
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Enschede, Netherlands, 7500 KA
- Medisch Spectrum Twente
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Nijmegen, Netherlands, NL-6500 HB
- Universitair Medisch Centrum St. Radboud - Nijmegen
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Oslo, Norway, N-0310
- Norwegian Radium Hospital
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Gdansk, Poland, 80-211
- Medical University of Gdansk
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Coimbra, Portugal, 3049
- Hospitais da Universidade de Coimbra (HUC)
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Cape Town, South Africa, 7925
- Groote Schuur Hospital
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Madrid, Spain, 28040
- Hospital Universitario San Carlos
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Oviedo, Spain, 33006
- Hospital Universitario Central de Asturias
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England
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Nottingham, England, United Kingdom, NG5 1PB
- Nottingham City Hospital NHS Trust
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Northern Ireland
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Belfast, Northern Ireland, United Kingdom, BT9 7AB
- Centre for Cancer Research and Cell Biology at Belfast City Hospital
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Scotland
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Glasgow, Scotland, United Kingdom, G11 6NT
- Western Infirmary
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
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
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 |
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Progression-free survival
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Relapse-free survival
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Secondary Outcome Measures
Outcome Measure |
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Overall survival
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Collaborators and Investigators
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
General Publications
- Hogberg T, Signorelli M, de Oliveira CF, Fossati R, Lissoni AA, Sorbe B, Andersson H, Grenman S, Lundgren C, Rosenberg P, Boman K, Tholander B, Scambia G, Reed N, Cormio G, Tognon G, Clarke J, Sawicki T, Zola P, Kristensen G. Sequential adjuvant chemotherapy and radiotherapy in endometrial cancer--results from two randomised studies. Eur J Cancer. 2010 Sep;46(13):2422-31. doi: 10.1016/j.ejca.2010.06.002. Epub 2010 Jul 7.
- 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.
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Uterine Neoplasms
- Genital Neoplasms, Female
- Uterine Diseases
- Endometrial Neoplasms
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Antibiotics, Antineoplastic
- Cisplatin
- Epirubicin
- Doxorubicin
- Liposomal doxorubicin
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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