KCT0008399招募中Unknown
Phase III randomized trial of HIPEC in Primary Stage three & Four Ovarian Cancer after Interval Cytoreductive Surgery (FOCUS)
ational Cancer Center0 个研究点目标入组 520 人开始时间: 待定最近更新:
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 发起方
- 入组人数
- 520
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 19(Year) 至 80(Year)（—）
- 性别
- Female
入选标准
- •1. A person aged 19 years or older but younger than 80 years of age at the time of providing informed written consent
- •2. Among patients diagnosed with histologically confirmed FIGO stage 3-4 epithelial ovarian, fallopian tube, or primary peritoneal cancer, patients who underwent Interval cytoreductive surgery after 3 cycles of neoadjuvant chemotherapy
- •3. Patients with residual tumor depth less than 2.5mm after Interval cytoreductive surgery
- •4. Persons with a life expectancy of 3 months or more at the time of clinical trial assignment
- •5. It has adequate organ function. (Specimens must be collected within 28 days.)
- •1) Adequate bone marrow function
- •ANC (Absolute Neutrophil Count)= 1,000/?
- •Platelet count = 80,000/?
- •Hemoglobin= 8.5 g/dl (After correction in case of anemia)
- •2) Adequate renal function
- •Creatinine or creatinine clearance (GFR can also be used instead of Cr or CrCl)= 2.0 x ULN
- •CrCl=60mL/min or GFR-EPI= 60mL/min/1.73m2
- •3) Adequate liver function
- •-Total bilirubin= 2.0 x ULN (For patients with confirmed Gilbert's syndrome, participation is permitted if unconjugated bilirubin < 5.0 x ULN.)
- •- Aspartate aminotransferase/Serum Glutamic Oxaloacetic Transaminase (ASAT/SGOT)) and Alanine aminotransferase /Serum Glutamic Pyruvate Transaminase (ALAT/SGPT)) = 3.0 x ULN.(For subjects with liver metastases, = 5.0 x ULN is applied.)
- •4)If there is no significant functional disorder in the heart, lungs, etc.
- •*GFR = glumerular filtration rate; ULN = upper limit of normal
- •6. Women who are medically unable to conceive or, if they are of childbearing potential, agree to follow birth control guidelines during treatment
- •7. Patients for whom the subject (or legal representative) gave informed written consent for the trial
- •8.Patients who can also give consent/consent to the provision of clinical information for secondary use such as future biomedical research. (However, even if the subject is not willing to participate in biomedical research or clinical information sharing, he or she can participate in the main trial)
排除标准
- •1. Patients whose histological diagnosis including germ cell tumor is non-epithelial ovarian cancer or borderline tumor
- •2. Patients who have not undergone neoadjuvant chemotherapy
- •3. Patients with residual tumor depth greater than 2.5 mm after Interval cytoreductive surgery.
- •4. Those whose life expectancy is less than 3 months at the time of clinical trial assignment
- •5. Diagnosis of other carcinomas within 5 years of clinical trial assignment or ongoing treatment that affects ovarian cancer treatment or affects treatment results
- •However, the following are exceptions.
- •: Malignant tumors that have been treated for curative purposes and are judged to have a low risk of recurrence
- •: Appropriately treated skin cancer (basal cell or squamous cell cancer) Concurrent early (FIGO IA G1/2) endometrial cancer
- •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 carcinomatous meningitis. Subjects previously treated for brain metastasis must be radiologically stable.
- •8. Patients with antibacterial, antifungal, or antiviral infections requiring parenteral systemic treatment
- •-Administration of prophylactic antiviral drugs during chemotherapy for patients with hepatitis is excluded
- •9. Active tuberculosis (TB) uncontrolled within 2 weeks of administration
- •10. Mental Illness – Patients diagnosed with a mental illness or substance use disorder that may interfere with their ability to cooperate on the study.
- •11. Patients with contraindications to the use of Cisplatin
- •12. Patients with a history of allogeneic tissue/solid organ transplantation or bone marrow transplantation or a history of double umbilical cord transplantation
- •13. Patients who, in the judgment of other principal investigators, are unlikely to comply with the test procedures and restrictions and requirements in the test
研究者
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