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LYmphadenectomy After NeoAdjuvant Chemotherapy

NCT01724944 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2012-11-12

No results posted yet for this study

Summary

The purpose of this study is to determine the role of lymphadenectomy in advenced ovarian cancer patients at the time of interval debulking surgery after neoadjuvant chemiotherapy.

Moreover it is a prospective trial, aimed to investigate the prognostic role of sistematic lymphadenectomy in terms of percentage of micrometastases detected, morbidity (complications rate), progression free interval, overall survival, recurrence pattern.

Conditions

  • Advanced Ovarian Cancer (Stage III or IV) After Neoadjuvant Chemotherapy

Interventions

PROCEDURE

Systematic pelvic and aortic lymphadenectomy

Pelvic lymphadenectomy dissection began at the origin of the external iliac vessels and continued caudally along the medial border of the psoas muscle, with the lower limit of the external iliac lymphadenectomy being represented by the deep inferior epigastric vessels. The lateral boundaries of lymphadenectomy were delineated superficially by the fascia covering the psoas muscle and deeply by the fascia covering the internal obturator and levator ani muscles. Lymph nodes along the external iliac vessels were removed en bloc with those adjacent to the common iliac vessels. Aortic lymphadenectomy dissection began at the aortic bifurcation by removing the superficial intercavoaortic, precaval, and preaortic nodal groups. Lymph nodes located lateral to the vena (i.e., paracaval nodal group) were separated from the vena cava, then removed en bloc. Lymph nodes behind the vena cava are removed if enlarged. Removal of the lateroaortic nodes was performed up to the level of the left renal vein.

Sponsors & Collaborators

  • Catholic University of the Sacred Heart

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-02-28
Primary Completion
2013-02-28

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01724944 on ClinicalTrials.gov