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

NCT01595204 | Completed DMC

• 1 other identifier: P/758/CE/2009
• Study Type: interventional
• Target: 163
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Cancer of Ovary

Keywords

Cancer of Ovary, laparoscopy, operability , score.

Outcome Measures

Primary Outcomes (1)

• 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

  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.

  2 years

Secondary Outcomes (2)

• Multicentric prospective validation of a laparoscopic PI in AOC patients

  2 years

• progression Free Survival; Overall survival

  2 years

Study Arms (1)

Diagnostic Laparoscopy

EXPERIMENTAL

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

Procedure: Diagnostic laparoscopy

Interventions

Diagnostic laparoscopy PROCEDURE

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.

Diagnostic Laparoscopy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Catholic University of the Sacred Heart: lead

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

Laparoscopy

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: May 8, 2012
• First Posted: May 9, 2012
• Study Start: March 1, 2010
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: May 22, 2012

Record last verified: 2012-05