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

Tracking Information
First Submitted Date ICMJE	May 2, 2000
First Posted Date ICMJE	January 27, 2003
Last Update Posted Date	August 2, 2013
Study Start Date ICMJE	January 2000
Primary Completion Date	Not Provided
Current Primary Outcome Measures ICMJE; (submitted: December 11, 2006)	Progression-free survival; Relapse-free survival
Original Primary Outcome Measures ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00005583 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: December 11, 2006)	Overall survival
Original Secondary Outcome Measures ICMJE	Not Provided
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Radiation Therapy With or Without Chemotherapy in Treating Patients With High-Risk Endometrial Cancer
Official Title ICMJE	A Randomized Trial of Adjuvant Treatment With Radiation Plus Chemotherapy Versus Radiation Alone in High Risk Endometrial Carcinoma
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.
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 ICMJE	Interventional
Study Phase	Phase 3
Study Design ICMJE	Allocation: Randomized; Masking: None (Open Label); Primary Purpose: Treatment
Condition ICMJE	Endometrial Cancer
Intervention ICMJE	Drug: cisplatin; Drug: doxorubicin hydrochloride; Drug: epirubicin hydrochloride; Procedure: adjuvant therapy; Procedure: conventional surgery; Radiation: radiation therapy
Study Arms	Not Provided
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.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Estimated Enrollment ICMJE; (submitted: November 8, 2006)	400
Original Enrollment ICMJE	Not Provided
Actual Study Completion Date	July 2010
Primary Completion Date	Not Provided
Eligibility Criteria ICMJE	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
Sex/Gender	Sexes Eligible for Study: Female
Ages	Child, Adult, Senior
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Belgium, France, Ireland, Italy, Netherlands, Norway, Poland, Portugal, South Africa, Spain, United Kingdom
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00005583
Other Study ID Numbers ICMJE	NSGO-EC9501; CDR0000067646 ( Registry Identifier: PDQ (Physician Data Query) ); EORTC-55991
Has Data Monitoring Committee	Not Provided
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Not Provided
Study Sponsor ICMJE	Nordic Society for Gynaecologic Oncology
Collaborators ICMJE	European Organisation for Research and Treatment of Cancer - EORTC
Investigators ICMJE	Study Chair: Gunnar B. Kristensen, MD, PhD Norwegian Radium Hospital Investigator: Carlos F. de Oliveira, MD, PhD Hospitais da Universidade de Coimbra (HUC)
PRS Account	National Cancer Institute (NCI)
Verification Date	November 2006
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP