Hyperthermic Intraperitoneal Chemotherapy for Treatment of Relapsed Ovarian Cancer

Study Overview
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Brief Summary
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This is a feasibility single-center study to investigate the tolerability, toxicity, quality of life, morbidity, mortality of the HIPEC treatment following cytoreductive surgery for treatment of recurrent ovarian, peritoneal, and fallopian tube cancers.

Detailed Description
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Ovarian cancer is the leading cause of gynecological cancer mortality; it is in 75% of cases detected at advanced stages. The standard treatment is cytoreductive surgery with removal of macroscopic tumor, and intravenous chemotherapy. Three randomized trials observed survival gain for ovarian cancer patients that received intraperitoneal chemotherapy after the optimal cytoreduction, however catheter-related complications made the procedure not feasible. A one-time hyperthermic intraperitoneal chemotherapy, HIPEC, is an established for peritoneal carcinosis in colorectal cancer, and recently two phase III randomised clinical studies observe survival gain also for ovarian cancer patients after surgery with HIPEC. Here the investigators, plan to investigate the HIPEC procedure following cytoreductive surgery for recurrent ovarian cancer, a progressed disease without any standard treatment established.

Official Title
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Feasibility of Intraoperative Given Hyperthermic Intraperitoneal Chemotherapy (HIPEC) With Cisplatin During a Cytoreductive Surgery in Patients With Recurrent Ovarian, Peritoneal or Fallopian Tube Cancers

Conditions
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Ovarian Cancer Recurrent

Intervention / Treatment
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* Procedure: radical surgery with HIPEC


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with diagnosis of recurrent epithelial ovarian carcinoma, peritoneal carcinoma, or fallopian tube carcinoma after 6 month since platinum-based chemotherapy (first recurrence) and are scheduled for secondary surgical evaluation/cytoreduction ECOG/WHO Performance score of 0 to 1 Adequate respiratory, hepatic, cardiac, kidney and bone marrow function ( Hb >= 8 g/dl, absolute neutrophil count > 1500/mm3, platelets > 100,000/mm3, creatinine clearance > 60 mL/min according to Cockroft formula) Adequate renal function Creatinine ≤ 1.5 mg/dl, and adequate hepatic function Bilirubin ≤ 1.5 mg/dl and AST and ALT ≤ 80 IU/L Histological types feature would be serous, endometrioid, clear cell, undifferentiated carcinomas, transitional cell carcinoma, or mixed epithelial carcinoma No end organ function Patients must have less than or equal to 2.5 mm residual disease at the completion of the cytoreductive surgery to be eligible for the study Patient-compliant and psychologically able to follow the trial procedures, signature of informed consent. Exclusion Criteria: Evidence of extensive retroperitoneal lymph node disease Neuropsychiatric disorders; Pregnancy or breast feeding. Subjects who have received prior radiotherapy to any portion of the abdominal cavity or pelvis are excluded Subjects with invasive malignancies or had any evidence of the other cancer present within the last 3 years. Prior radiation for localized cancer of the breast, head and neck, or skin are permitted, provided that it was completed more than 3 years prior to enrollment, and the subject remains free of recurrent or metastatic disease Subjects with active infection that requires parenteral antibiotics Tumors of low malignant potential, or non-invasive borderline tumors Patients with any underlying cardiac, pulmonary, metabolic, renal, hepatic or gastrointestinal conditions, chronic or latent infectious diseases, immune deficiency, or history, which in the opinion of the investigator, places the patient at an unacceptable risk for participation in the study Patient with extra-abdominal metastatic disease Known platinum (carboplatin or cisplatin) allergy Life expectancy < 3 months Still, it will not be considered for the HIPEC protocol those patients with unresectable disease (presence of invasive peritoneal implants inoperable or at high risk for resection in critical locations such as hepatic hilum, the mesenteric root, trunk celiac, mesentery, and several small implants the serosa of the small intestine) and / or with residual disease after cytoreduction greater than or equal to 2.5 mm (CC-2 and CC-3).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Complete cytoreductive surgery plus HIPEC with cis-platinum100mg/m2 for 90 min<br> | Procedure: radical surgery with HIPEC<br>* Straight after macroscopic radical cytoreductive surgery, an intraperitoneal hyperthermic perfusion using the open-abdomen technique will be performed with a single dose of cisplatin 100 mg/m2 administered for 90 minutes in the hyperthermic phase (41°C-43°C).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment-related toxicities | Registration of the effects according to NCI CTCAEv4.0 guidelines. | 3 months after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of quality of life | EORTC C30 quality of life questionnaire | before surgery, and 4 weeks, 3 months and 6 months after surgery | 
| Assessment of quality of life in relation to ovarian cancer | EORTC OV28 quality of life questionnaire | before surgery, and 4 weeks, 3 months and 6 months after surgery | 
| Assessment of quality of Life in relation to eventually performed intestinal surgery | EORTC CR29 quality of life questionnaire | before surgery, and 4 weeks, 3 months and 6 months after surgery | 
| Morbidity | Rate of the high-grade 3 and 4 complications, according to the Clawien-Dindo scale | 30 days after surgery | 
| Mortality | Number of participants with lethal outcome | 90 days after surgery |