Phase III Randomized Study of Adjuvant Radiotherapy With or Without Chemotherapy in Patients With High-Risk Endometrial Carcinoma. Note: The information about this trial has not been updated by the sponsor/principal investigator/lead organization. Cancer.gov cannot verify the accuracy of the information.
Radiation Therapy With or Without Chemotherapy in Treating Patients With High-Risk Endometrial Cancer. Note: The information about this trial has not been updated by the sponsor/principal investigator/lead organization. Cancer.gov cannot verify the accuracy of the information.
Basic Trial Information
|Phase III||Treatment||Closed||Any age||Other||NSGO-EC9501|
- 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.
- 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
- Not specified
- Not specified
- Not specified
- No prior preoperative irradiation
- No prior extensive abdominal surgery
- Any age
- WHO 0-2
- Not specified
- Adequate bone marrow function
- WBC at least 3,500/mm3
- Platelet count at least 100,000/mm3
- 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
A total of 400 patients (200 per treatment arm) will be accrued for this study within 5 years.
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.
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.
Hogberg T, Signorelli M, de Oliveira CF, et al.: Sequential adjuvant chemotherapy and radiotherapy in endometrial cancer--results from two randomised studies. Eur J Cancer 46 (13): 2422-31, 2010.[PUBMED Abstract]
Trial Contact Information
Trial Lead Organizations
Nordic Society for Gynaecologic Oncology
European Organization for Research and Treatment of Cancer
Ph: 351-239-400-500 ext. 10312
|Official Title||A Randomized Trial of Adjuvant Treatment with Radiation Plus Chemotherapy Versus Radiation Alone in High Risk Endometrial Carcinoma|
|Trial Start Date||2000-01-11|
|Registered in ClinicalTrials.gov||NCT00005583|
|Date Submitted to PDQ||2000-02-07|
|Information Last Verified||2006-11-19|
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.