HIPEC for Platinum-Resistant Recurrent Ovarian Cancer

Study Overview
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Brief Summary
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Platinum-resistant recurrent epithelial ovarian cancer randomizing with or without hyperthermic intraperitoneal chemotherapy (HIPEC)

Detailed Description
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The objective of this trial (KOV-HIPEC-02) is to prove the survival benefit of HIPEC with doxorubicin and mitomycin (trial arm) compared to physician-choice chemotherapy (control arm) in patients with platinum-resistant recurrent epithelial ovarian cancer.

Official Title
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Randomized Phase III Trial of Hyperthermic Intraperitoneal Chemotherapy (HIPEC) for Platinum-Resistant Recurrent Ovarian Cancer

Conditions
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Epithelial Ovarian Cancer

Intervention / Treatment
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* Procedure: HIPEC


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients ≥18 years old, Patients with Eastern Cooperative Oncology Group (ECOG) Performance status 0-2, Patients diagnosed with histologically confirmed epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer, Resistant to platinum-based chemotherapy (Platinum-refractory or resistant disease) Resectable intraperitoneal disease based on previous clinical history and recent image finding, A life expectancy > 3 months as clinically judged, Women who are medically unable to conceive or who are of childbearing potential, agree to follow contraceptive guidelines during treatment, Patient can also consent to the provision of clinical information for secondary use such as future biomedical research. However, in the future, subjects can participate in the main trial even if they do not intend to participate in sharing clinical information and, Adequate organ function for cytoreductive surgery and HIPEC Exclusion criteria: Non-epithelial ovarian carcinoma, Borderline ovarian tumor, Patients who are not appropriate for surgical and HIPEC procedures based on previous surgery or clinical findings, including severe intestinal adhesions, obstruction, or abdominal fistula, Patients with myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) or with features suggestive of MDS/AML, Patients which extra-abdominal disease is a major disease or is expected to cause of death, Patients with active central nervous system metastasis and carcinoma meningitis or patients who have been previously treated for brain metastases must be in a stable state in radiology, Patients with antibacterial, antifungal, or antiviral infections requiring systemic treatment (administration of parenteral antibiotics), Active tuberculosis that is not controlled within 1 month of treatment, Patient diagnosed with a psychiatric disorder or substance abuse disorder that would interfere with your ability to cooperate with the trial, Patients who have not undergone hysterectomy and have a positive urine pregnancy test result within 14 days prior to clinical trial assignment, even if the urine pregnancy test result is negative at screening, Pregnant or lactating women, Patients with any contraindications to the use of doxorubicin or mitomycin (i.e., hypersensitivity to doxorubicin or mitomycin), Patients with a history of allogeneic tissue/solid organ transplantation or bone marrow transplantation or a history of double umbilical cord transplantation or, History or current evidence of any condition, therapy, or laboratory abnormality that may confound the results of the study, interfere with the patient's participation, in the opinion of the treating investigator.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized controlled, open-label, multicenter phase III trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HIPEC<br>Intraoperative Hyperthermic Intraperitoneal Chemotherapy (HIPEC) followed by physician-choice chemotherapy until disease progression. | Procedure: HIPEC<br>* HIPEC perfusion, doxorubicin 35mg/m2 & mitomycin 15 mg/m2, 41.5'C, 90 min.<br>|
| No Intervention: No HIPEC<br>Physician-choice chemotherapy from enrollment until disease progression. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival (PFS) |  | From randomization to time of first progression or death from any cause, whichever came first, assessed up to 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival (OS) |  | From randomization to the date of death from any cause, assessed up to 5 years | 
| cancer-specific survival |  | From randomization to the date of death due to ovarian cancer, assessed up to 5 years | 
| Treatment-related adverse events | assessed by CTCAE ver.5.0 | From randomization up to the end of treatment plus 6 weeks | 
| Health-related quality of life (QLQ C30) | assessed by EEuropean Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Score 30 (QLQ-C30) | Over the 5 year surveillance period | 
| Health-related quality of life (QLQ OV28) | assessed by European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Ovarian Cancer Module (QLQ-OV28) | Over the 5 year surveillance period | 
| Health-related quality of life (EQ-5D-5L) | assessed by the 5-level EQ-5D version (EQ-5D-5L) | Over the 5 year surveillance period | 
| Cost-effectiveness analysis | assessed by Quality-Adjusted Live Years (QALYs) | At time of completion of 5-year surveillance period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ovarian cancer, Hyperthermic intraperitoneal chemotherapy, HIPEC, Recurrent ovarian cancer