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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Catholic University of the Sacred Heart
Sponsor:
Information provided by (Responsible Party):
Prof. Giovanni Scambia, Catholic University of the Sacred Heart
ClinicalTrials.gov Identifier:
NCT01539785
First received: February 20, 2012
Last updated: August 21, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention
First Recurrence of Ovarian Cancer
Procedure: Secondary citoreduction
Procedure: Hyperthermic intra-peritoneal chemotherapy (HIPEC)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by Catholic University of the Sacred Heart:

Primary Outcome Measures:
  • Estimate of progression free interval (PFI) in the two trial arms. [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]
    The progression-free interval (PFI) will be evaluated from the time of secondary cytoreduction (± HIPEC) to the evidence of a second recurrence of disease.


Secondary Outcome Measures:
  • Estimate of overall survival (OS)in the two trial arms. [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]
    The overall survival (OS) will be evaluated from the time of secondary cytoreduction ± HIPEC to death or last FU.

  • Evaluation of the morbidity and mortality in the two trial arms. [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]

    Surgical complications and morbidity will be monitored and recorded in special forms both during surgery and during the period of hospital stay. The following complications should be reported to the coordinating center UCSC within 24 hours Events recorded during surgery and up to 60 days of the latter: transfusion of more than 10 units of blood in 24 hours, re-laparotomy for complications, pulmonary embolism, sepsis, death (regardless of cause), new hospitalization for surgical complication.

    Events between 60 days and the end of follow-up period: death (regardless of cause).



Estimated Enrollment: 158
Study Start Date: September 2012
Estimated Primary Completion Date: September 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Secondary cytoreduction
The eligible patients, after anesthesia preparation will be submitted to a surgical complete cytoreduction.
Procedure: Secondary citoreduction
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.
Experimental: Hyperthermic intra-peritoneal chemotherapy (HIPEC)
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)
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.

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  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01539785

Locations
Italy
Catholic University of Sacred the Hearth Recruiting
Rome, Italy, 00100
Contact: Catholic University of Sacred the Hearth    +39 063 015 627 9      
Principal Investigator: Fagotti Anna, MD, PhD         
Principal Investigator: Fanfani Francesco, MD         
Principal Investigator: Costantini Barbara, MD         
Principal Investigator: Perelli Federica, MD         
Sponsors and Collaborators
Catholic University of the Sacred Heart
  More Information

No publications provided by Catholic University of the Sacred Heart

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Prof. Giovanni Scambia, Direttore del Dipartimento per la Tutela della salute della Donna e della Vita Nascente Università Cattolica del Sacro Cuore-Roma, Catholic University of the Sacred Heart
ClinicalTrials.gov Identifier: NCT01539785     History of Changes
Other Study ID Numbers: 138/12
Study First Received: February 20, 2012
Last Updated: August 21, 2014
Health Authority: Italy: Ethics Committee, Catholic University of the Sacred Hearth

Keywords provided by Catholic University of the Sacred Heart:
HIPEC
Hyperthermic
ovarian cancer
recurrence

Additional relevant MeSH terms:
Fever
Ovarian Neoplasms
Recurrence
Adnexal Diseases
Body Temperature Changes
Disease Attributes
Endocrine Gland Neoplasms
Endocrine System Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Gonadal Disorders
Neoplasms
Neoplasms by Site
Ovarian Diseases
Pathologic Processes
Signs and Symptoms
Urogenital Neoplasms

ClinicalTrials.gov processed this record on November 25, 2014