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

Study Overview
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Brief Summary
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Phase II multicentric study

Detailed Description
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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.

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

Conditions
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Stage IV Ovarian Carcinoma, Effects of Chemotherapy, Peritoneal Cavity Cancer

Intervention / Treatment
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* Procedure: Laparoscopic interval debulking surgery


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Laparoscopic Interval Debulking Surgery<br>Patients affected by advanced epithelial ovarian cancer already submitted to neoadjuvant chemotherapy with evidence of complete/partial response | Procedure: Laparoscopic interval debulking surgery<br>* Diagnostic laparoscopy with a careful exploration of peritoneal cavity: if available a 5 mm flexible tip videolaparoscope will be used to explore all peritoneal recesses.For eligible patients,will be placed 3 5mm trocar in standard position for pelvic surgery:cytoreduction will consist in total/radical hysterectomy,bilateral salpingo-oophorectomy,radical omentectomy.If needed pelvic/upper peritonectomy will be performed:in these cases additional trocar can be placed in right or left subcostal spaces. All surgical procedure requested will have be carried out by laparoscopy/robotic or by laparotomy,in case of increased surgical risk or technical impossibility:the case will be registered as laparotomic conversion.At the end of surgical procedures residual tumor will be registered<br>* Other names: Laparoscopy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operative complication rate | Intra- and post-operative complication rate of total laparoscopic/robotic interval debulking surgery | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression Free survival | time to recurrence | one year | 
| Overall Survival | time to last follow up/death | One year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ovarian Cancer, Laparoscopy, Neoadjuvant Chemotherapy, Robotic, Interval Debulking Surgery