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

This study has been completed.
Sponsor:
Information provided by:
University of Roma La Sapienza
ClinicalTrials.gov Identifier:
NCT00482300
First received: June 4, 2007
Last updated: NA
Last verified: March 2007
History: No changes posted
  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: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

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

  Eligibility

Ages Eligible for Study:   up to 75 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by University of Roma La Sapienza

Additional 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
Study First Received: June 4, 2007
Last Updated: June 4, 2007
Health Authority: Italy: Ethics Committee

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

Additional relevant MeSH terms:
Endometrial Neoplasms
Sarcoma, Endometrial Stromal
Adenoma
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
 Uterine Diseases
Genital Diseases, Female
Neoplasms, Complex and Mixed
Neoplasms by Histologic Type
Sarcoma
Neoplasms, Connective and Soft Tissue
Endometrial Stromal Tumors
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on May 16, 2013