Clinical trial · Interventional
Hyperthermic Intra-peritoneal Chemotherapy (HIPEC) in Ovarian Cancer Recurrence
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.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to determine the role of surgery followed by hyperthermic intra-peritoneal chemotherapy (HIPEC) versus surgery alone in patients with platinum-sensitive first recurrence of ovarian cancer. Moreover it is a prospective randomized multicenter trial, aimed to investigate the prognostic role of surgery plus HIPEC versus surgery alone in terms of progression free interval, overall survival, morbidity and mortality, second recurrence pattern, quality of life with EORTC QLQ-C30 and QLQ OV28 questionnaires.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| First Recurrence of Ovarian Cancer | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hyperthermic intra-peritoneal chemotherapy (HIPEC) | Procedure | — | UNRESOLVED |
| Secondary citoreduction | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Secondary cytoreduction
- description
- The eligible patients, after anesthesia preparation will be submitted to a surgical complete cytoreduction.
- interventionNames
- Procedure: Secondary citoreduction
- type
- EXPERIMENTAL
- label
- Hyperthermic intra-peritoneal chemotherapy (HIPEC)
- description
- If the patient is randomized to make chemo-hyperthermia, surgery will be followed by HIPEC with the closed technique.
- interventionNames
- Procedure: Hyperthermic intra-peritoneal chemotherapy (HIPEC)
Primary outcomes (1)
- measure
- Estimate of progression free interval (PFI) in the two trial arms.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Age over 18 and under 70 years * Patients affected by a first recurrence of ovarian cancer with measurable lesions or not, but evaluable (upwards of Ca125 for 2 consecutive assessments). * ECOG-performance status ≤ 2 * Ovarian cancer limited to the abdominal cavity with or without extraperitoneal spread considered resectable at intraoperative evaluation * Evidence of tumor recurrence diagnosed after 6 months from primary treatment * Previous-based chemotherapy of carboplatin and taxanes * Positive Peritoneal Washing in the presence of other abdominal disease surgically resectable * Adequate respiratory, hepatic, cardiac, kidney and bone marrow function (absolute neutrophil count \> 1500/mm3, platelets \> 150,000/μl, creatinine clearance \> 60 mL/min according to Cockroft formula) * Patient-compliant and psychologically able to follow the trial procedures Exclusion Criteria: * Non-epithelial ovarian cancer or borderline ovarian tumor * Pregnancy or breastfeeding * Patients affected by major depressive disorder even in treatment or minor mood disorders * Patients with severe impairment of respiratory, hepatic or renal function * Patients with cardiac, neurological or metabolic uncontrolled pharmacologically disease * Patients with active infection or other neoplastic disease in progress * Patients with bowel obstruction * Inadequate bone marrow, liver, kidney function * No clear-peritoneal disease at surgical exploration * Patients with ascites \> 500 ml (the TAC) * Patients on maintenance therapy with Antiangiogenic drugs * Patients with secondary or tertiary recurrence, or already submitted to HIPEC * Patients who have already made the second or third line chemotherapy.
References
Publications (3)
- DERIVEDFagotti A, Costantini B, Fanfani F, Giannarelli D, De Iaco P, Chiantera V, Mandato V, Giorda G, Aletti G, Greggi S, Perrone AM, Salutari V, Trozzi R, Scambia G. Hyperthermic Intraperitoneal Chemotherapy in Platinum-Sensitive Recurrent Ovarian Cancer: A Randomized Trial on Survival Evaluation (HORSE; MITO-18). J Clin Oncol. 2025 Mar;43(7):852-860. doi: 10.1200/JCO.24.00686. Epub 2024 Nov 21. PMID 39571127
- DERIVEDPetrillo M, Zucchetti M, Cianci S, Morosi L, Ronsini C, Colombo A, D'Incalci M, Scambia G, Fagotti A. Pharmacokinetics of cisplatin during open and minimally-invasive secondary cytoreductive surgery plus HIPEC in women with platinum-sensitive recurrent ovarian cancer: a prospective study. J Gynecol Oncol. 2019 Jul;30(4):e59. doi: 10.3802/jgo.2019.30.e59. Epub 2019 Mar 1. PMID 31074245
- DERIVEDFagotti A, Petrillo M, Costantini B, Fanfani F, Gallotta V, Chiantera V, Turco LC, Bottoni C, Scambia G. Minimally invasive secondary cytoreduction plus HIPEC for recurrent ovarian cancer: a case series. Gynecol Oncol. 2014 Feb;132(2):303-6. doi: 10.1016/j.ygyno.2013.12.028. Epub 2013 Dec 27. PMID 24378877