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

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00003749
First received: November 1, 1999
Last updated: December 18, 2013
Last verified: April 1999
  Purpose

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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
Official Title: A Randomised Trial of Lymphadenectomy and of Adjuvant External Beam Radiotherapy in the Treatment of Endometrial Cancer

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 2300
Study Start Date: April 1998
Study Completion Date: December 2008
Detailed Description:

OBJECTIVES:

  • 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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

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)

PATIENT CHARACTERISTICS:

Age:

  • Any age

Performance status:

  • Not specified

Life expectancy:

  • Not specified

Hematopoietic:

  • Not specified

Hepatic:

  • Not specified

Renal:

  • Not specified

Other:

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • Not specified

Endocrine therapy:

  • Not specified

Radiotherapy:

  • Not specified

Surgery:

  • Not specified
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003749

Locations
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
Investigators
Investigator: Claire Amos Medical Research Council
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00003749     History of Changes
Other Study ID Numbers: CDR0000066869, MRC-ASTEC, EU-98062
Study First Received: November 1, 1999
Last Updated: December 18, 2013
Health Authority: United States: Federal Government

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
Genital Diseases, Female
Genital Neoplasms, Female
Neoplasms
Neoplasms by Site
Urogenital Neoplasms
Uterine Diseases
Uterine Neoplasms

ClinicalTrials.gov processed this record on November 24, 2014