Hyperthermic Intra-peritoneal Chemotherapy (HIPEC) in Ovarian Cancer Recurrence

NCT01539785 | Unknown DMC

• 1 other identifier: 138/12
• Study Type: interventional
• Target: 158
• Locations: 1 country
• Sites: 1

Brief Summary

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

First Recurrence of Ovarian Cancer

Keywords

HIPEC; Hyperthermic; ovarian cancer; recurrence

Outcome Measures

Primary Outcomes (1)

• Estimate of progression free interval (PFI) in the two trial arms.

  The progression-free interval (PFI) will be evaluated from the time of secondary cytoreduction (± HIPEC) to the evidence of a second recurrence of disease.

  36 months

Secondary Outcomes (2)

• Estimate of overall survival (OS)in the two trial arms.

  36 months

• Evaluation of the morbidity and mortality in the two trial arms.

  36 months

Study Arms (2)

Secondary cytoreduction

ACTIVE COMPARATOR

The eligible patients, after anesthesia preparation will be submitted to a surgical complete cytoreduction.

Procedure: Secondary citoreduction

Hyperthermic intra-peritoneal chemotherapy (HIPEC)

EXPERIMENTAL

If the patient is randomized to make chemo-hyperthermia, surgery will be followed by HIPEC with the closed technique.

Procedure: Hyperthermic intra-peritoneal chemotherapy (HIPEC)

Interventions

Secondary citoreduction PROCEDURE

The eligible patients, after anesthesia preparation will be submitted to a surgical complete cytoreduction attempt that consist in the removal of all macroscopically visible tumor nodules from the visceral and parietal peritoneum. To obtain a complete cytoreduction, different procedures are required, as described by Sugarbaker (30), which may include omentectomy, splenectomy, diaphragmatic, pelvic,parietal peritonectomy and / or visceral, bowel resection, hepatic resection and cholecystectomy.

Secondary cytoreduction

Hyperthermic intra-peritoneal chemotherapy (HIPEC) PROCEDURE

If the patient is randomized to make chemo-hyperthermia, surgery will be followed by HIPEC with the closed technique, that consist in the perfusion of the abdominal cavity with a solution containing cisplatin (CDDP) 75 mg/m2 in 2L/m2 heated saline. The solution is heated and perfused with two special pumps (Hyperex, Korea or Stoeckert munich). The temperature of inflow and outflow of the solution, will be maintained, respectively, between 41 ° and 42.5 ° C. The intraperitoneal temperature will be maintained at 41.5 ° C and monitored by thermometers inserted into the subphrenic space and into the pelvis. After 60 minutes of perfusion the surgical incision will be open after removal of the entire solution. The global temperature will be measured by thermometer inserted into the esophagus and rectum. A Swan-Ganz catheter will be kept in place during the HIPEC for monitoring cardiovascular function.

Hyperthermic intra-peritoneal chemotherapy (HIPEC)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Catholic University of the Sacred Heart: lead

Study Sites (1)

Catholic University of Sacred the Hearth

Rome, Rome, 00100, Italy

RECRUITING

Related Publications (3)

• Fagotti 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 DERIVED

• Petrillo 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 DERIVED

• Fagotti 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 DERIVED

MeSH Terms

Conditions

Fever; Ovarian Neoplasms; Recurrence

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Disease Attributes; Pathologic Processes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Direttore del Dipartimento per la Tutela della salute della Donna e della Vita Nascente Università Cattolica del Sacro Cuore-Roma

Study Record Dates

• First Submitted: February 20, 2012
• First Posted: February 28, 2012
• Study Start: September 1, 2012
• Primary Completion: September 1, 2018
• Last Updated: August 22, 2014

Record last verified: 2014-08

Locations

IT (1)