Surgery With or Without Lymphadenectomy and Radiation Therapy in Treating Patients With Endometrial Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00003749
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : December 19, 2013
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

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 or disease Intervention/treatment Phase
Endometrial Cancer Procedure: adjuvant therapy Procedure: conventional surgery Radiation: brachytherapy Radiation: radiation therapy Phase 3

Detailed Description:


  • Compare the effects of conventional surgery alone and conventional surgery plus lymphadenectomy in patients with endometrial cancer preoperatively thought to be confined to the uterine corpus.
  • Determine the effect of postoperative adjuvant external beam radiotherapy on quality of life and survival of a subset of these patients at high risk of relapse and with no macroscopic disease after surgery.

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.

    • Arm I: Patients undergo conventional surgery (total abdominal hysterectomy and bilateral salpingo-oophorectomy).
    • Arm II: Patients undergo conventional surgery as in arm I followed by lymphadenectomy with systematic dissection of the iliac and obturator nodes.
  • 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.)

    • Arm I: Patients receive in 20-25 fractions of external beam radiotherapy (total dose of 40-46 Gy) over 4-5 weeks.
    • Arm II: Patients receive no external beam radiotherapy. 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.

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2300 participants
Allocation: Randomized
Primary Purpose: Treatment
Official Title: A Randomised Trial of Lymphadenectomy and of Adjuvant External Beam Radiotherapy in the Treatment of Endometrial Cancer
Study Start Date : April 1998
Actual Study Completion Date : December 2008

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Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No


Surgical randomization:

  • Histologically confirmed endometrial carcinoma
  • Disease thought preoperatively to be confined to the uterine corpus

Radiotherapy randomization:

  • Must have disease determined postoperatively to be confined to the uterine corpus, irrespective of pelvic node status

    • No cervical stroma invasion (stage IIB)
  • Must be macroscopically free of disease (no positive para-aortic nodes)
  • Must have high-risk disease defined as one or more of the following:

    • Grade 3 (poorly differentiated)
    • Invasion to the outer half of the myometrium (stage IC)
    • Serous papillary or clear cell type
    • Stage IIA (endocervical glandular involvement)



  • Any age

Performance status:

  • Not specified

Life expectancy:

  • Not specified


  • Not specified


  • Not specified


  • Not specified


  • No other prior or concurrent malignancy likely to interfere with protocol treatment or comparisons
  • Surgical randomization:

    • Must be fit to undergo lymphadenectomy and external beam radiotherapy
  • Radiotherapy randomizations:

    • Must be fit to receive external beam radiotherapy


Biologic therapy:

  • Not specified


  • Not specified

Endocrine therapy:

  • Not specified


  • Not specified


  • Not specified

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00003749

United Kingdom
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
Sponsors and Collaborators
Medical Research Council
OverallOfficial: Claire Amos Medical Research Council

Publications of Results:
Other Publications: Identifier: NCT00003749     History of Changes
Other Study ID Numbers: CDR0000066869
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: December 19, 2013
Last Verified: April 1999

Keywords provided by National Cancer Institute (NCI):
stage I endometrial carcinoma
stage II endometrial carcinoma
endometrial clear cell carcinoma
endometrial papillary serous carcinoma

Additional relevant MeSH terms:
Endometrial Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Diseases
Genital Diseases, Female