Systematic Pelvic Lymphadenectomy Versus no Lymphadenectomy in Clinical Stage I-II Endometrial Cancer
Sponsor
University of Roma La Sapienza (Other)
Overall Status
Completed
CT.gov ID
NCT00482300
Collaborator
(none)
Study Details
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Outcome Measures
Primary Outcome Measures
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
to 75 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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
Locations
No locations specified.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
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00482300
Other Study ID Numbers:
- PTC-CBM-15
First Posted:
Jun 5, 2007
Last Update Posted:
Jun 5, 2007
Last Verified:
Mar 1, 2007
Keywords provided by ,
,
Additional relevant MeSH terms: