Interval Cytoreductive Surgery With or Without HIPEC for Ovarian Cancer (FOCUS / KOV-04)

National Cancer Center (NCC)

Status and phase: Enrolling; Phase 3

Conditions: Ovarian Cancer

Treatments: Drug: Cisplatin

Study type: Interventional

Funder types: Other

Identifiers

NCT05827523

NCC2023-0100

Details and patient eligibility

About

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

Full 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.

Enrollment: 520 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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520 participants in 2 patient groups

HIPEC

Experimental group

Description:

Interval cytoreductive surgery with HIPEC

Treatment:

Drug: Cisplatin

No HIPEC

No Intervention group

Description:

Interval cytoreductive surgery without HIPEC