Phase 3 Trial Evaluating Hyperthermic Intraperitoneal Chemotherapy in Upfront Treatment of Stage IIIC Epithelial Ovarian Cancer

Summary

Aim of the Study is to compare two-years disease-free survival of Cytoreductive Surgery (CRS) and Hyperthermic IntraPEritoneal Chemotherapy (HIPEC, CDDP+Paclitaxel) vs CRS alone in Stage IIIC unresectable epithelial tubal/ovarian cancer with partial or complete response after 3 cycles of 1st line chemotherapy (CBDCA +Paclitaxel).

Key Facts

Interventions

Conditions

Eligibility

Inclusion Criteria:

* Female adult women (18 to 70 years old) patients, with EOC (FIGO stage IIIc) with a Fagotti modified Laparoscopic Scoring System ≥ 4 who will show a complete clinical response (cCR) or partial clinical response (cPR) after 3 cycles (Carboplatin+Paclitaxel) of neoadjuvant chemotherapy;
* performance status (ECOG) 0, 1 or 2;
* signed informed consent.

Exclusion Criteria:

* refusing to sign an informed consent;
* age \> 70 years and age \<18 years;
* BMI \> 35;
* impossibility of an adequate follow-up;
* presence of other active neoplasms;
* active infection or other concurrent medical condition that could interfere in the ability of patients to receive the proposed treatment according to protocol;
* extraabdominal metastases (Stage IV) ;
* performance status (ECOG)\>2;
* complete bowel obstruction;
* Abnormal bone marrow indices or renal and liver function;
* ASA IV or V.

Outcome Measures

Locations

Linked Diseases