Surgery plus Hyperthermic Intra-PEritoneal Chemotherapy (HIPEC) versus surgery alone in patients with platinum-sensitive first recurrence of ovarian cancer:

Presentazione sul tema: "Surgery plus Hyperthermic Intra-PEritoneal Chemotherapy (HIPEC) versus surgery alone in patients with platinum-sensitive first recurrence of ovarian cancer:"— Transcript della presentazione:

1 Surgery plus Hyperthermic Intra-PEritoneal Chemotherapy (HIPEC) versus surgery alone in patients with platinum-sensitive first recurrence of ovarian cancer: a prospective randomized multicenter trial. PROTOCOL ID: HORSE Hyperthermic intra-peritoneal chemotherapy (HIPEC) in platinum-sensitive Ovarian cancer recurrence: Randomized trial on Survival Evaluation.

2 Inclusion Criteria Exclusion Criteria
years -first recurrence of EOC with measurable or not measurable lesions, but evaluable (upwards of Ca125 for 2 consecutive assessments). -ECOG-performance status ≤ 2 -disease limited to the abdominal cavity with or without extraperitoneal spread considered resectable at intraoperative evaluation -recurrence after ≥6 months from primary treatment -Previous-based chemotherapy of carboplatin and taxanes -Peritoneal Washing-positive in the presence of other abdominal disease surgically resectable -Adequate respiratory, hepatic, cardiac, kidney and bone marrow function -Patient compliant and psychologically able to follow the trial procedures Exclusion Criteria - Non-epithelial ovarian cancer or borderline ovarian tumor - Pregnancy or breastfeeding - Major depressive disorder even in treatment or minor mood disorders - Impairment of bone marrow, respiratory, hepatic or renal function -Cardiac, neurological or metabolic uncontrolled disease - Active infection or other neoplastic disease in progress -Bowel obstruction -No clear-peritoneal disease at surgical exploration - Ascites> 500 ml (the TAC) -Maintenance therapy with Antiangiogenic -Secondary or tertiary recurrence, or previous HIPEC, or previous second or third line chemotherapy.

3 Patients included (inclusion/exclusion criteria)
LPT: Maximal Surgical Effort Patients eligible (CC-0; CC-1) Patients not eligible (CC>1) Randomization CDDP 75 mg/m2 in 2L/m2 SF temperature 41.5C for 60 min 79 HIPEC NO 79 HIPEC YES Pl based CHT Pl based CHT Drop-out FU FU Drop-out

4 Status: On going Enrollement 126 patients 63 ARM A 63 ARM B

5 Principal Investigator
Arruolamento per centro CODICE CENTRO ISTITUTO Principal Investigator Pazienti Arruolate Braccio A Braccio B 001 Policlinico Gemelli-UCSC UO di Ginecologia Oncologica Giovanni Scambia 94 47 003 Casa di cura Fondazione Giovanni Paolo II Campobasso Vito Chiantera 6 2 4 005 A.O. per l'emergenza Cannizzaro SC di Ginecologia ed Ostetricia Paolo Scollo / 006 IEO di Milano Angelo Maggioni 1 007 IRCCS Arcispedale S. Maria Nuova, Oncologia Medica, Martino Abrate 3 029 Centro di Chirurgia Oncologica avanzata c/o Clinica Chirurgica Enricomaria Pasqual 030 Istituto Nazionale Tumori Napoli Stefano Greggi 032 Ospedale Sant'Orsola Malpighi -Bologna- Pierandrea De Iaco 13 8 5 038 IRCCS Centro di Riferimento Oncologico CRO Aviano (PN) Giorgio Giorda 046 AUSLL 11 di Empoli Ospedale San Giuseppe Empoli (FI) PI Marco Filippeschi - SOMMA 126 63