Surgical Complications Related to Primary or Interval Debulking in Ovarian Neoplasm
Conditions
Stage IIIC Ovarian Cancer
Conditions: official terms
Ovarian Neoplasms
Study Type
Interventional
Study Phase
N/A
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment
Intervention
Name: Laparoscopy Type: Procedure
Name: Cytoreduction Type: Procedure
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 75 Years
Minimum Age: 18 Years
Gender: Female
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
Location
Catholic University of the Sacred Heart
Rome, Italy
Status: Recruiting
Contact: Giovanni Scambia, Professor - +39-06-30156279 - clinicaltrials@rm.unicatt.it
Start Date
September 2011
Completion Date
September 2014
Sponsors
Catholic University of the Sacred Heart
Source
Catholic University of the Sacred Heart
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
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