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

NCT01539785 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 158

Last updated 2014-08-22

No results posted yet for this study

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

Interventions

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.

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.

Sponsors & Collaborators

  • Catholic University of the Sacred Heart

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-09-30
Primary Completion
2018-09-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01539785 on ClinicalTrials.gov