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

Официальное название

Phase III Randomized Trial of HIPEC in Primary Stage Three & Four Primary Ovarian Cancer After Interval Cytoreductive Surgery (FOCUS, KOV-04)

Обзор

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

Подробное описание

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.

Вмешательства

• Препарат Cisplatin
  Hyperthermic intraperitoneal chemotherapy (HIPEC) with cisplatin 75mg/m2 after interval cytoreductive surgery

Первичные конечные точки

• Overall survival (OS) [Срок оценки: From randomization to the date of death from any cause, assessed up to 5 years]

Вторичные конечные точки (8)

• Progression-free survival (PFS) [Срок оценки: From randomization to time of first progression or death from any cause, whichever came first, assessed up to 5 years]
• Cancer-specific survival [Срок оценки: From randomization to the date of death due to ovarian cancer, assessed up to 5 years]
• Time to first subsequent therapy (TFST) [Срок оценки: 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]
• Treatment-related adverse events [Срок оценки: From randomization up to the end of treatment plus 4 weeks]
• Health-related quality of life (EORTC-QLQ-C30) [Срок оценки: Over the 5 year surveillance period]
• Health-related quality of life (EORTC-QLQ-OV28) [Срок оценки: Over the 5 year surveillance period]
• Health-related quality of life (EQ-5D-5L) [Срок оценки: Over the 5 year surveillance period]
• Cost-effectiveness analysis [Срок оценки: At time of completion of 5-year surveillance period]

Критерии участия

Критерии включения

• Signed and written informed consent,
• Patients ≥18, <80 years old,
• 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,
• Treated with interval complete cytoreduction, or cytoreduction with no more than 2.5 mm depth of residual disease,
• A life expectancy > 3 months as clinically judged,
• Adequate organ function for cytoreductive surgery and HIPEC,
• Women who are medically unable to conceive or who are of childbearing potential, agree to follow contraceptive guidelines during treatment and,
• 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.

Критерии исключения

• Diagnosed with non-epithelial ovarian carcinoma or borderline ovarian tumor
• Patients who have not undergone neoadjuvant chemotherapy,
• Interval cytoreduction with more than 2.5 mm depth of residual disease,
• A life expectancy ≤3 months as clinically judged,
• 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,
• Patients with myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) or with features suggestive of MDS/AML,
• 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,
• Patients diagnosed with a psychiatric disorder or substance abuse disorder that would interfere with your ability to cooperate with the trial,
• Patients with any contraindications to the use of cisplatin (i.e., hypersensitivity to cisplatin),
• 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, or interfere with the patient's participation, in the opinion of the treating investigator.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

South Korea · 10 центров

• Chungnam National University Hospital — Sejong
• Chungnam National University Sejong Hospital — Sejong
• Ilsan CHA University Hospital — Goyang-si
• National Cancer Center — Goyang-si
• Ajou University Hospital — Suwon
• Pusan National University Hospital — Pusan
• Pusan National University Yangsan Hospital — Pusan
• Asan Medical Center — Seoul
• … и ещё 2 центра

Идентификаторы

NCT: NCT05827523 · NCC2023-0100

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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