Status:
COMPLETED
Surgical Complications Related to Primary or Interval Debulking in Ovarian Neoplasm
Lead Sponsor:
Catholic University of the Sacred Heart
Conditions:
Stage IIIC Ovarian Cancer
Eligibility:
FEMALE
18-75 years
Phase:
PHASE3
Brief 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 che...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 31 2016
Estimated Enrollment :
171 Patients enrolled
Trial Details
Trial ID
NCT01461850
Start Date
October 1 2011
End Date
May 31 2016
Last Update
October 14 2020
Active Locations (1)
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1
Catholic University of the Sacred Heart
Rome, Italy, 00168