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Systematic Pelvic Lymphadenectomy Versus no Lymphadenectomy in Clinical Stage I-II Endometrial Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00482300
First Posted: June 5, 2007
Last Update Posted: June 5, 2007
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.
Information provided by:
University of Roma La Sapienza
  Purpose
The purpose of this trial is to determine whether the addition of systematic pelvic lymphadenectomy to hysterectomy with bilateral adnexectomy improves disease-free survival (DFS) and overall survival (OS) in patients with preoperatively supposed Stage I-II endometrial cancer

Condition Intervention
Endometrial Cancer Procedure: Systematic pelvic lymphadenectomy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Further study details as provided by University of Roma La Sapienza:

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 75 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically proven endometrioid or adenosquamous endometrial carcinoma.
  • Patients having myometrial invasion
  • Age =/< 75 years
  • Informed consent.

Exclusion Criteria:

  • Serous papillary and clear cell tumors.
  • Karnofsky index < 80 or severe diseases contraindicating surgery
  • Concomitant neoplasia (basalioma cutis excluded)
  • Distant metastasis or abdominal metastasis detected intraoperatively.
  • Absence of myometrial invasion at frozen section.
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00482300


Sponsors and Collaborators
University of Roma La Sapienza
Investigators
Study Chair: Pierluigi Benedetti Panici, Full Professor Department of Obstetrics and Gynecology University La Sapienza of Rome
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00482300     History of Changes
Other Study ID Numbers: PTC-CBM-15
First Submitted: June 4, 2007
First Posted: June 5, 2007
Last Update Posted: June 5, 2007
Last Verified: March 2007

Keywords provided by University of Roma La Sapienza:
Histologically proved endometrial carcinoma preoperatively supposed stage I-II

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