Phase III Randomized Study of Lymphadenectomy and Adjuvant External Beam Radiotherapy in Patients With 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.
First Published: 3/1/1999  Last Modified: 6/20/2011
Surgery With or Without Lymphadenectomy and Radiation Therapy in Treating Patients With 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
A minimum of 1400 patients will be accrued for the surgical component of this study and at least 900 patients (including additional patients not participating in the surgical component of this study) will be accrued for the radiotherapy component of this study.
This is a randomized, multicenter study. Patients are randomized in both the surgery and radiotherapy segments of the study.
[Note: Some patients receive vault brachytherapy regardless of radiotherapy randomization.]
Quality of life is assessed before therapy and at 2 and 5 years after therapy.
Patients are followed every 3 months for 1 year and then every 6 months for 1 year.
Kitchener HC: The effect of incision in the surgical treatment of endometrial cancer and long-term follow-up of a randomized trial of lymphadenectomy: results of the MRC ASTEC trial. [Abstract] J Clin Oncol 29 (Suppl 15): A-e15583, 2011.
Kitchener H, Swart AM, Qian Q, et al.: Efficacy of systematic pelvic lymphadenectomy in endometrial cancer (MRC ASTEC trial): a randomised study. Lancet 373 (9658): 125-36, 2009.[PUBMED Abstract]
Barton DP, Naik R, Herod J: Efficacy of systematic pelvic lymphadenectomy in endometrial cancer (MRC ASTEC Trial): a randomized study. Int J Gynecol Cancer 19 (8): 1465, 2009.[PUBMED Abstract]
Blake P, Swart AM, Orton J, et al.: Adjuvant external beam radiotherapy in the treatment of endometrial cancer (MRC ASTEC and NCIC CTG EN.5 randomised trials): pooled trial results, systematic review, and meta-analysis. Lancet 373 (9658): 137-46, 2009.[PUBMED Abstract]
Trial Contact Information
Trial Lead Organizations
Medical Research Council Clinical Trials Unit
Claire Amos, Study coordinator
Ph: 44-020-7670-4700 ext. 4795
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.