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

Catholic University of the Sacred Heart

Status and phase: Completed; Phase 2

Conditions: Effects of Chemotherapy; Peritoneal Cavity Cancer; Stage IV Ovarian Carcinoma

Treatments: Procedure: Laparoscopic interval debulking surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT02324595

10279/14

Details and patient eligibility

About

Phase II multicentric study

Full 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.

Enrollment: 30 patients

Sex: Female

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Laparoscopic Interval Debulking Surgery

Experimental group

Description:

Patients affected by advanced epithelial ovarian cancer already submitted to neoadjuvant chemotherapy with evidence of complete/partial response

Treatment:

Procedure: Laparoscopic interval debulking surgery