NCT05827523招募中3 期
Phase III Randomized Trial of HIPEC in Primary Stage Three & Four Primary Ovarian Cancer After Interval Cytoreductive Surgery (FOCUS, KOV-04)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 520
- 试验地点
- 10
- 主要终点
- Overall survival (OS)
研究概览
简要总结
Primary stage III-IV epithelial ovarian cancer randomizing between interval cytoreductive surgery with or without hyperthermic intraperitoneal chemotherapy (HIPEC)
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Enrolled patients are unaware of which group they have been assigned to.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
HIPEC
Experimental
Interval cytoreductive surgery with HIPEC
干预措施: Cisplatin (Drug)
No HIPEC
No Intervention
Interval cytoreductive surgery without HIPEC
结局指标
主要结局
Overall survival (OS)
时间窗: From randomization to the date of death from any cause, assessed up to 5 years
次要结局
- Health-related quality of life (EQ-5D-5L)(Over the 5 year surveillance period)
- Progression-free survival (PFS)(From randomization to time of first progression or death from any cause, whichever came first, assessed up to 5 years)
- Time to first subsequent therapy (TFST)(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)
- Cost-effectiveness analysis(At time of completion of 5-year surveillance period)
- Cancer-specific survival(From randomization to the date of death due to ovarian cancer, assessed up to 5 years)
- Treatment-related adverse events(From randomization up to the end of treatment plus 4 weeks)
- Health-related quality of life (EORTC-QLQ-OV28)(Over the 5 year surveillance period)
- Health-related quality of life (EORTC-QLQ-C30)(Over the 5 year surveillance period)
研究者
Myong Cheol Lim, MD, PhD
Principal Researcher
National Cancer Center, Korea
研究点 (10)
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