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

Primary Purpose

Endometrial Cancer

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Systematic pelvic lymphadenectomy
Sponsored by
University of Roma La Sapienza
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endometrial Cancer focused on measuring Histologically proved endometrial carcinoma preoperatively supposed stage I-II

Eligibility Criteria

undefined - 75 Years (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    June 4, 2007
    Last Updated
    June 4, 2007
    Sponsor
    University of Roma La Sapienza
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00482300
    Brief Title
    Systematic Pelvic Lymphadenectomy Versus no Lymphadenectomy in Clinical Stage I-II Endometrial Cancer
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2007
    Overall Recruitment Status
    Completed
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    University of Roma La Sapienza

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Endometrial Cancer
    Keywords
    Histologically proved endometrial carcinoma preoperatively supposed stage I-II

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized

    8. Arms, Groups, and Interventions

    Intervention Type
    Procedure
    Intervention Name(s)
    Systematic pelvic lymphadenectomy

    10. Eligibility

    Sex
    Female
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Pierluigi Benedetti Panici, Full Professor
    Organizational Affiliation
    Department of Obstetrics and Gynecology University La Sapienza of Rome
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    19033573
    Citation
    Benedetti Panici P, Basile S, Maneschi F, Alberto Lissoni A, Signorelli M, Scambia G, Angioli R, Tateo S, Mangili G, Katsaros D, Garozzo G, Campagnutta E, Donadello N, Greggi S, Melpignano M, Raspagliesi F, Ragni N, Cormio G, Grassi R, Franchi M, Giannarelli D, Fossati R, Torri V, Amoroso M, Croce C, Mangioni C. Systematic pelvic lymphadenectomy vs. no lymphadenectomy in early-stage endometrial carcinoma: randomized clinical trial. J Natl Cancer Inst. 2008 Dec 3;100(23):1707-16. doi: 10.1093/jnci/djn397. Epub 2008 Nov 25.
    Results Reference
    derived

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

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