Validation of a Laparoscopic Score to Predict the Chance of Optimal Cytoreduction in Advanced Ovarian Cancer Patients (MITO13)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Prof. Giovanni Scambia, Catholic University of the Sacred Heart
ClinicalTrials.gov Identifier:
NCT01595204
First received: May 8, 2012
Last updated: May 20, 2012
Last verified: May 2012
  Purpose

Prospective multicenter study that aims to evaluate the learning curve of a laparoscopic score to predict possibility of optimal cytoreduction in patients with ovarian / tubal / peritoneal advanced at the time of first surgery. The study consists of subjecting all patients with a clinical suspicion and / or radiological diagnostic laparoscopy (SLPs).

Laparoscopy should be described and recorded in electronic form. After the procedure each patient will have a Laparoscopic-evaluation-form filled up with a laparoscopic score (PI). The minimum number of cases to be enrolled is 10 patients, in a minimum time of 1 year. The data collected and the video should be sent to the Center Coordinator, who will determine the adequacy of the procedure and the accuracy of the score enrollment is completed for each center. All eligible subjects will be considered by intention-to-treat population (ITT). For this phase of the study, it is not necessary know the outcome of the surgical patient (RT) or if it was then subjected to exploratory laparotomy or less.


Condition Intervention
Cancer of Ovary
Procedure: Diagnostic laparoscopy

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Olympia-MITO13-validation of a Laparoscopic Score to Predict the Chance of Optimal Cytoreduction in Advanced Ovarian Cancer Patients: an Open-label Prospective Multicentric-trial.

Resource links provided by NLM:


Further study details as provided by Catholic University of the Sacred Heart:

Primary Outcome Measures:
  • a prospective and multicentric validation of the laparoscopic score (PI), developed at the Catholic University of the Sacred Hearth (UCSC), to predict surgical outcome in primary AOC patients [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    The primary objective of this study is to obtain a prospective and multicentric validation of the laparoscopic score (PI), developed at the Catholic University of the Sacred Hearth (UCSC), to predict surgical outcome in primary AOC patients. In particular, we want to identify the PI cut-off value, at which AOC patients can be reasonably considered not optimally resectable (RT< 1 cm) in an expert referring centre for AOC treatment, thus avoiding an unnecessary exploratory xipho-pubic laparotomy.


Secondary Outcome Measures:
  • Multicentric prospective validation of a laparoscopic PI in AOC patients [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • progression Free Survival; Overall survival [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Enrollment: 163
Study Start Date: March 2010
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Diagnostic Laparoscopy
Laparoscopy will be performed in each case of clinical/radiological suspicious primary advanced ovarian/peritoneal cancer.
Procedure: Diagnostic laparoscopy

Laparoscopy will be performed in each case of clinical/radiological suspicious primary advanced ovarian/peritoneal cancer.

After the introduction of the trocar and the optic, pneumoperitoneum is induced and one or two ancillary trocars are inserted in the iliac fossae bilaterally or where it is possible. A careful complete abdominal and pelvic inspection is carried out in order to identify any possible cause of non optimal cytoreduction. All peritoneal surfaces and the gutters are closely examined and the liver is evaluated by rotating the laparoscope 360° through the umbilical port using grasping forceps as retractors. The small bowel loops and mesentery are evaluated by carefully folding back the various intestinal segments. The pelvis is explored after the bowel loops are retracted in the upper abdomen when possible. At the end of laparoscopy, a PI value is elaborated, based on table given to participant centers.


  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age > 18 years
  • Patients with a diagnosis suspect for advanced ovarian cancer (FIGO stage III-IV)
  • Life expectancy of at least 4 weeks
  • Performance Status ≤ 2
  • Adequate respiratory, hepatic, cardiological, medullar and renal function (Creatinine Clearance > 60 mL/min according to Cockcroft's formula)
  • Compliant patient with psychological ability to follow the study procedures

Exclusion Criteria:

  • Pregnancy or nursing.
  • Inadequate respiratory, hepatic, cardiological, medullar and renal function, that avoid safe surgery.
  • Patients with cancer mass occupying the entire abdomen or infiltrating abdominal wall.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01595204

Sponsors and Collaborators
Catholic University of the Sacred Heart
Investigators
Principal Investigator: Anna Fagotti, MD PhD Catholic University of Sacred Heart
Principal Investigator: Giovanni Scambia, MD Catholic University of Sacred Heart
Principal Investigator: Francesco Fanfani, MD Catholic University of Sacred Heart
  More Information

No publications provided

Responsible Party: Prof. Giovanni Scambia, Medical Doctor, Catholic University of the Sacred Heart
ClinicalTrials.gov Identifier: NCT01595204     History of Changes
Other Study ID Numbers: P/758/CE/2009
Study First Received: May 8, 2012
Last Updated: May 20, 2012
Health Authority: Italy: Ethics Committee

Keywords provided by Catholic University of the Sacred Heart:
Cancer of Ovary, laparoscopy, operability , score.

Additional relevant MeSH terms:
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders

ClinicalTrials.gov processed this record on August 25, 2014