NCT00482300

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

Trial Health

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 4, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 5, 2007

Completed
Last Updated

June 5, 2007

Status Verified

March 1, 2007

First QC Date

June 4, 2007

Last Update Submit

June 4, 2007

Conditions

Endometrial Cancer

Keywords

Histologically proved endometrial carcinoma preoperatively supposed stage I-II

Interventions

Systematic pelvic lymphadenectomyPROCEDURE

Eligibility Criteria

AgeUp to 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 19033573DERIVED

MeSH Terms

Conditions

Endometrial Neoplasms

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Pierluigi Benedetti Panici, Full Professor

    Department of Obstetrics and Gynecology University La Sapienza of Rome

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 4, 2007

First Posted

June 5, 2007

Last Updated

June 5, 2007

Record last verified: 2007-03