Minimally Invasive Interval Debulking Surgery in Ovarian Neoplasm: a Feasibility Study

Phase 2

Completed

• Conditions: Effects of Chemotherapy; Peritoneal Cavity Cancer; Stage IV Ovarian Carcinoma
• Interventions: Procedure: Laparoscopic interval debulking surgery

• Registration Number: NCT02324595
• Lead Sponsor: Catholic University of the Sacred Heart

Brief Summary

Phase II multicentric study

Detailed Description

The aim of this prospective Phase II multicentric study is to assess feasibility and early complications rate of "total laparoscopic/robotic" interval debulking surgery in patients with a clinical complete/partial response to neoadjuvant chemotherapy for advanced ovarian cancer.

Study Timeline

• Study Start: 2013-12
• Study First Submitted: 2014-06-17
• Study First Submitted QC: 2014-12-23
• Study First Posted: 2014-12-24
• Primary Completion: 2015-02
• Study Completion: 2016-02
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-11
• Last Update Posted: 2016-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 30

Inclusion Criteria

• Age >18 years,
• Advanced ovarian cancer submitted to neoadjuvant chemotherapy,
• Clinical or serological complete/partial response (RECIST; GCIG),
• PS ≤ 2 (ECOG),
• Informed consent

Exclusion Criteria

• Borderline and non-epithelial ovarian tumors,
• Stable/progressive disease,
• ASA 3-4,
• Severe cardiopulmonary disease,
• BMI > 40

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Laparoscopic Interval Debulking Surgery	Laparoscopic interval debulking surgery	Patients affected by advanced epithelial ovarian cancer already submitted to neoadjuvant chemotherapy with evidence of complete/partial response

Primary Outcome Measures

Name	Time	Method
Operative complication rate	30 days	Intra- and post-operative complication rate of total laparoscopic/robotic interval debulking surgery

Secondary Outcome Measures

Name	Time	Method
Overall Survival	One year	time to last follow up/death
Progression Free survival	one year	time to recurrence

Trial Locations

Locations (2)

Catholic University of Sacred Heart Rome,; 🇮🇹 Rome,, Rome, Italy

Policlinico Agostino Gemelli; 🇮🇹 Rome, Italy