NCT05316181进行中（未招募）3 期
Randomized Phase III Trial of Cytoreductive Surgery (CRS) and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) for Platinum-Resistant Recurrent Ovarian Cancer: KOV-02R - Resistant Cancer of Ovary (RECOVER)
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 140
- 试验地点
- 3
- 主要终点
- Progression-free survival (PFS)
研究概览
简要总结
Platinum-resistant recurrent epithelial ovarian cancer randomizing with or without cytoreductive surgery + hyperthermic intraperitoneal chemotherapy (HIPEC): KOV-02R, RECOVER
详细描述
The objective of this trial (KOV-HIPEC-02R) 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.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Cytoreductive surgery and HIPEC
Experimental
Cytoreductive surgery + Hyperthermic Intraperitoneal Chemotherapy (HIPEC) followed by physician-choice chemotherapy until disease progression.
干预措施: HIPEC (Procedure)
No HIPEC
No Intervention
Physician-choice chemotherapy from enrollment until disease progression.
结局指标
主要结局
Progression-free survival (PFS)
时间窗: From randomization to time of first progression or death from any cause, whichever came first, assessed up to 5 years
次要结局
- Treatment-related adverse events(From randomization up to the end of treatment plus 6 weeks)
- Health-related quality of life (QLQ C30)(Over the 5 year surveillance period)
- Overall survival (OS)(From randomization to the date of death from any cause, assessed up to 5 years)
- Health-related quality of life (EQ-5D-5L)(Over the 5 year surveillance period)
- cancer-specific survival(From randomization to the date of death due to ovarian cancer, assessed up to 5 years)
- Cost-effectiveness analysis(At time of completion of 5-year surveillance period)
- Health-related quality of life (QLQ OV28)(Over the 5 year surveillance period)
研究者
Myong Cheol Lim, MD, PhD
Principal investigator
National Cancer Center, Korea
研究点 (3)
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