None listed
Conditions
Interventions
Drug, Procedure/Surgery : 1. Experimental: HIPEC group (Arm A)
For patients assigned to the HIPEC (Hyperthermic Intraperitoneal Chemotherapy) group, HIPEC is performed after Interval cytoreductive sur
Sponsors
National Cancer Center
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 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 or 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)
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| OS: Overall survival | — |
Secondary
| Measure | Time frame |
|---|---|
| PFS: Progression free survival;CSS: Cancer-Specific Survival ;TFST :Time to first subsequent therapy;toxicity;Quality of Life;Economic evaluation analysis of HIPEC | — |
Countries
Korea, Republic of
Contacts
Public ContactMyong Cheol Lim
National Cancer Center
Outcome results
None listed