Stage IIIC Unresectable Epithelial Ovarian/Tubal Cancer With Partial or Complete Response After 1st Line Neoadjuvant Chemotherapy (3 Cycles CBDCA+Paclitaxel): a Phase 3 Prospective Randomized Study Comparing Cytoreductive Surgery + Hyperthermic Intraperitoneal Chemotherapy (CDDP+Paclitaxel) + 3 Cycles CBDCA+Paclitaxel vs Cytoreductive Surgery Alone + 3 Cycles CBDCA+Paclitaxel.
Eligible: Female adult women (18 to 70 years old) patients, with epithelial ovarian/tubal
(FIGO stage IIIC) with a Fagotti modified Laparoscopic Scoring System ≥ 4 who will show a
complete or partial clinical response(RECIST 1.1) after 3 cycles of neoadjuvant chemotherapy
Duration of recruitment: 2 years. Sample size has been calculated to reach a confidence
level of 95% with a power of 80%, considering a 45% and 75% disease-free survival at 2 years
in CRS and CRS+HIPEC group respectively.
Sample size will be 47 patients for each group. After CRS, only patients with adequate
cytoreduction (CC 0-1, residual tumor ≤ 2.5mm) will be randomized. Patients with suboptimal
cytoreduction (CC 2-3, residual tumor > 2.5mm) are not suitable for randomization.
The drug schedule elected in the current study is Cisplatin (CDDP) (100 mg/m2 of body
surface area) + Paclitaxel (175mg/m2 of body surface area).
Closed/open technique, as preferred. Duration: 90 minutes. Mean Intra-abdominal Temperature:
42°C. Primary Endpoint: 2-years disease-free survival.
1-year, 3- and 5-years disease-free survival;
1 month, 1-year, 3- and 5-years overall survival; toxicity induced by HIPEC using the NCI
CTC criteria; one month and six months morbidity; duration of operation; return of bowel
function; length of hospital stay; return to normal activity; six months and one year QOL,
using the SF-36 v1.0; percentage of patients in both arms completing the scheduled
postoperative chemotherapy; Subgroup analysis: PCI ≤ 15; pts. ≤ 40yrs.
Main topics of this Study:
Focused only on upfront treatment of primary disease. Select platinum-sensible patients
(responders to platinum-based neoadjuvant chemotherapy).
Take advantage of NACT to maximize chances for cytoreduction. Standardized strategy for CRS:
radical surgery, associated to any surgical procedure needed to obtain a zero or ≤ 0.25cm
residual tumor (peritonectomy, bowel resection, diaphragmatic stripping, gastric resection,
etc.). Pelvic and peri-aortic lymphadenectomy is not chosen as standard procedure, but
should warrant adequate staging.
Compare only the effect of HIPEC.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Disease free survival
Luca Ansaloni, MD
Ospedali Riuniti di Bergamo
Italy: Nerviano Medical Sciences