Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
Medical Research Council |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00003749 |
RATIONALE: Lymphadenectomy may remove cancer cells that have spread to nearby lymph nodes. Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known whether conventional surgery is more effective with or without lymphadenectomy and/or radiation therapy in treating endometrial cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of conventional surgery with or without lymphadenectomy and/or radiation therapy in treating patients who have endometrial cancer.
Condition | Intervention | Phase |
---|---|---|
Endometrial Cancer |
Procedure: adjuvant therapy Procedure: conventional surgery Radiation: brachytherapy Radiation: radiation therapy |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Active Control |
Official Title: | A Randomised Trial of Lymphadenectomy and of Adjuvant External Beam Radiotherapy in the Treatment of Endometrial Cancer |
Estimated Enrollment: | 2300 |
Study Start Date: | April 1998 |
OBJECTIVES:
OUTLINE: This is a randomized, multicenter study. Patients are randomized in both the surgery and radiotherapy segments of the study.
Surgery: Patients are randomized to 1 of 2 surgery arms.
Radiotherapy: Patients at high risk of relapse who have no postoperative macroscopic disease are randomized to 1 of 2 radiotherapy arms. (Patients may enter the radiotherapy randomization after surgery off study.)
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.
PROJECTED ACCRUAL: 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.
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Surgical randomization:
Radiotherapy randomization:
Must have disease determined postoperatively to be confined to the uterine corpus, irrespective of pelvic node status
Must have high-risk disease defined as one or more of the following:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
Surgical randomization:
Radiotherapy randomizations:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
United Kingdom, England | |
Medical Research Council Clinical Trials Unit | |
London, England, United Kingdom, NW1 2DA | |
Royal Marsden NHS FoundationTrust - London | |
London, England, United Kingdom, SW3 6JJ | |
St. Mary's Hospital | |
Manchester, England, United Kingdom, M13 0JH |
Investigator: | Claire Amos | Medical Research Council |
Study ID Numbers: | CDR0000066869, MRC-ASTEC, EU-98062 |
Study First Received: | November 1, 1999 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00003749 History of Changes |
Health Authority: | United States: Federal Government |
stage I endometrial carcinoma stage II endometrial carcinoma endometrial clear cell carcinoma endometrial papillary carcinoma |
Genital Diseases, Female Endometrial Neoplasms Adenocarcinoma, Clear Cell Adjuvants, Immunologic Genital Neoplasms, Female Carcinoma, Papillary |
Uterine Diseases Uterine Neoplasms Endometrial Cancer Urogenital Neoplasms Carcinoma |
Genital Diseases, Female Neoplasms Endometrial Neoplasms Neoplasms by Site |
Genital Neoplasms, Female Uterine Diseases Uterine Neoplasms Urogenital Neoplasms |