Clinical trial NCT05827523: Interval Cytoreductive Surgery With or Without HIPEC for Ovarian Cancer
Official title: Phase III Randomized Trial of HIPEC in Primary Stage Three & Four Primary Ovarian Cancer After Interval Cytoreductive Surgery (FOCUS, KOV-04)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Ovarian Cancer
Keywords: Ovarian cancer
Hyperthermic intraperitoneal chemotherapy
HIPEC
Interval cytoreductive surgery
Neoadjuvant chemotherapy
Carcinoma, Ovarian Epithelial
Epithelial ovarian cancer
Lead sponsor: National Cancer Center, Korea
Sponsor class: OTHER_GOV
First posted: 2023-04-25
Enrollment: 520
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled, single-blinded, multicenter phase III trial
Primary purpose: TREATMENT

Brief summary: Primary stage III-IV epithelial ovarian cancer randomizing between interval cytoreductive surgery with or without hyperthermic intraperitoneal chemotherapy (HIPEC)

Detailed description: The goal of this phase III randomized controlled trial is to compare the clinical efficacy of HIPEC with cisplatin (trial arm) compared to no HIPEC (control arm) during interval cytoreductive surgery followed by neoadjuvant chemotherapy, in patients with stage III-IV primary epithelial ovarian cancer.

Eligibility criteria: Inclusion Criteria:

1. Signed and written informed consent,
2. Patients ≥18, \<80 years old,
3. Diagnosed with histologically confirmed FIGO stage III-IV primary epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer treated with three cycles of neoadjuvant chemotherapy,
4. Treated with interval complete cytoreduction, or cytoreduction with no more than 2.5 mm depth of residual disease,
5. A life expectancy \> 3 months as clinically judged,
6. Adequate organ function for cytoreductive surgery and HIPEC,
7. Women who are medically unable to conceive or who are of childbearing potential, agree to follow contraceptive guidelines during treatment and,
8. Patients 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.

Exclusion Criteria:

1. Diagnosed with non-epithelial ovarian carcinoma or borderline ovarian tumor
2. Patients who have not undergone neoadjuvant chemotherapy,
3. Interval cytoreduction with more than 2.5 mm depth of residual disease,
4. A life expectancy ≤3 months as clinically judged,
5. History of previous malignancy within five years prior to inclusion, that affects ovarian cancer treatment results, with the exception of carcinoma in situ, radically excised basal cell or squamous cell cancer of the skin, or synchronal endometrial carcinoma FIGO IA G1/2,
6. Patients with myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) or with features suggestive of MDS/AML,
7. 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,
8. Patients with antibacterial, antifungal, or antiviral infections requiring systemic treatment (administration of parenteral antibiotics),
9. Active tuberculosis that is not controlled within 1 month of treatment,
10. Patients diagnosed with a psychiatric disorder or substance abuse disorder that would interfere with your ability to cooperate with the trial,
11. Patients with any contraindications to the use of cisplatin (i.e., hypersensitivity to cisplatin),
12. Patients with a history of allogeneic tissue/solid organ transplantation or bone marrow transplantation or a history of double umbilical cord transplantation or,
13. History or current evidence of any condition, therapy, or laboratory abnormality that may confound the results of the study, or interfere with the patient's participation, in the opinion of the treating investigator.

Primary outcomes:
measure: Overall survival (OS)
timeFrame: From randomization to the date of death from any cause, assessed up to 5 years
Secondary outcomes:
measure: Progression-free survival (PFS)
timeFrame: From randomization to time of first progression or death from any cause, whichever came first, assessed up to 5 years
measure: Cancer-specific survival
timeFrame: From randomization to the date of death due to ovarian cancer, assessed up to 5 years
measure: Time to first subsequent therapy (TFST)
timeFrame: from the last day of the last cycle of a prior regimen of chemotherapy to the first day of the first cycle of the subsequent chemotherapy, assessed up to 5 years
measure: Treatment-related adverse events
timeFrame: From randomization up to the end of treatment plus 4 weeks
measure: Health-related quality of life (EORTC-QLQ-C30)
timeFrame: Over the 5 year surveillance period
measure: Health-related quality of life (EORTC-QLQ-OV28)
timeFrame: Over the 5 year surveillance period
measure: Health-related quality of life (EQ-5D-5L)
timeFrame: Over the 5 year surveillance period
measure: Cost-effectiveness analysis
timeFrame: At time of completion of 5-year surveillance period
Other outcomes:
Locations:
city: Goyang
country: Korea, Republic of
facility: National Cancer Center
state: Gyeonggi
Study officials:
References: