Surgical Complications Related to Primary or Interval Debulking in Ovarian Neoplasm

• Status: Completed
• Trial end date: 2016-05-31
• Target enrollment: 0
• Participant gender: Female

Summary

Patients with advanced ovarian cancer (FIGO stage III C) and highly disseminated tumor will be randomized into two arms: primary debulking surgery followed by adjuvant chemotherapy vs. neoadjuvant chemotherapy followed by interval debulking surgery (IDS). The primary end point is the evaluation and comparison of the surgical complications of primary surgery and IDS and the evaluation of the progression free survival (PFS)

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Catholic University of the Sacred Heart

Criteria

Inclusion Criteria:

• Patients with suspected advanced ovarian cancer (FIGO stage IIIC)

• PIV ≥ 8, PIV ≤ 12

• Estimated life expectancy of at least 4 weeks.

• PS ≤ 2

• Appropriate respiratory, hepatic, cardiological, bone marrow and renal functions (Creatinine Clearance > 60 mL/min according to Cockcroft formula)

• Patient capable of consent.

Exclusion Criteria:

• Pregnancy or breastfeeding.

• Non-appropriate respiratory, hepatic, cardiological, bone marrow and renal functions

• Large size mass reaching the xiphoid, occupying all the abdominal cavity and/or infiltrating the abdominal wall.

• Mesenteric retraction