Hyperthermic Intra-peritoneal Chemotherapy (HIPEC) in Ovarian Cancer Recurrence (HORSE)
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|ClinicalTrials.gov Identifier: NCT01539785|
Recruitment Status : Recruiting
First Posted : February 28, 2012
Last Update Posted : August 22, 2014
|Condition or disease||Intervention/treatment|
|First Recurrence of Ovarian Cancer||Procedure: Secondary citoreduction Procedure: Hyperthermic intra-peritoneal chemotherapy (HIPEC)|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||158 participants|
|Intervention Model:||Parallel Assignment|
|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.|
|Study Start Date :||September 2012|
|Estimated Primary Completion Date :||September 2018|
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.
- Estimate of progression free interval (PFI) in the two trial arms. [ Time Frame: 36 months ]The progression-free interval (PFI) will be evaluated from the time of secondary cytoreduction (± HIPEC) to the evidence of a second recurrence of disease.
- Estimate of overall survival (OS)in the two trial arms. [ Time Frame: 36 months ]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 ]
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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01539785
|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|