Surgical Complications Related to Primary or Interval Debulking in Ovarian Neoplasm

PHASE3CompletedINTERVENTIONAL
Enrollment

171

Participants

Timeline

Start Date

October 1, 2011

Primary Completion Date

November 30, 2014

Study Completion Date

May 31, 2016

Conditions
Stage IIIC Ovarian Cancer
Interventions
DRUG

Neoadjuvant chemotherapy + Interval Debulking Surgery

Patients with suspected advanced ovarian cancer (FIGO stage IIIC) will undergo only to diagnostic laparoscopy. Omental cake, diaphragmatic or peritoneal extensive carcinomatosis, tumor diffusion to the small and large curvature of the stomach, large and/or small bowel mesentery disease, spleen and/or liver metastases will be investigated in order to obtain a laparoscopic score. After neoadjuvant chemotherapy interval debulking surgery will be performed: total hysterectomy, bilateral salpingo-oophorectomy, radical omentectomy, appendectomy, pelvic and paraaortic lymphadenectomy, eventual bowel resection, eventual bladder resection, eventual splenectomy, eventual parietal and diaphragmatic peritonectomy, eventual gastric resection, eventual hepatic resection, eventual pancreas resection, eventual cholecystectomy.

PROCEDURE

Primary Debulking Surgery + Adjuvant Chemotherapy

Patients with suspected advanced ovarian cancer (FIGO stage IIIC) will undergo to diagnostic laparoscopy. Omental cake, diaphragmatic or peritoneal extensive carcinomatosis, tumor diffusion to the small and large curvature of the stomach, large and/or small bowel mesentery disease, spleen and/or liver metastases will be investigated in order to obtain a laparoscopic score. Then, an attempt of laparotomic cytoreduction will be performed: total hysterectomy, bilateral salpingo-oophorectomy, radical omentectomy, appendectomy, pelvic and paraaortic lymphadenectomy, eventual bowel resection, eventual bladder resection, eventual splenectomy, eventual parietal and diaphragmatic peritonectomy, eventual gastric resection, eventual hepatic resection, eventual pancreas resection, eventual cholecystectomy.

Trial Locations (1)

00168

Catholic University of the Sacred Heart, Rome

All Listed Sponsors
lead

Catholic University of the Sacred Heart

OTHER

NCT01461850 - Surgical Complications Related to Primary or Interval Debulking in Ovarian Neoplasm | Biotech Hunter | Biotech Hunter