KCT0007111招募中未知
Randomized Phase III Trial of HIPEC in Platinum-Resistant Recurrent Ovarian Cancer
ational Cancer Center0 个研究点目标入组 140 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 140
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19(Year) 至 o Limit（—）
- 性别
- Female
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
- •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.
研究者
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