Status:
UNKNOWN
HIPEC in the Treatment of Stage IIc-IV Epithelial Ovarian Cancer After CRS (HIPECOC)
Lead Sponsor:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborating Sponsors:
Zhejiang University
Conditions:
Ovarian Cancer
Hyperthermic Intraperitoneal Chemotherapy
Eligibility:
FEMALE
18-70 years
Phase:
NA
Brief Summary
This study evaluate the Hyperthermic Intraperitoneal Chemotherapy(HIPEC) in the treatment of Stage IIc-IV epithelial Ovarian Cancer after primary Cytoreductive Surgery (CRS).Half participants will rec...
Detailed Description
Advanced epithelial ovarian cancer, now recognized as the most effective treatment is maximizing tumor reduction (cytoreductice surgery, CRS) within the abdominal cavity with platinum-based chemothera...
Eligibility Criteria
Inclusion
- the patient voluntarily joined the study and signed the consent form;
- female patients aged between 18 and 70 who are not pregnant or lactating;
- primary epithelial ovarian cancer, fallopian tube cancer and primary peritoneal cancer were diagnosed at the time of diagnosis, and no chemotherapy or radiotherapy was given within three months before the study began;
- laparoscopic Fagotti score \<6;
- residual lesions in abdominal cavity after tumor cell extinction \<1cm;
- expected survival time ≥12 weeks;
- ECOG score: 0-1;
- bone marrow reserve function is good, and blood routine indexes meet the following requirements: white blood cell count ≥3.0×109/L, neutrophil absolute count ≥1.5×109/L, platelet count ≥100×109/L, hemoglobin ≥90 g/L;
- important organs function well and blood biochemical indexes meet the following requirements: serum albumin ≥30 g/L, ALT≤2.5× normal upper limit (ULN), AST≤2.5×ULN, serum total bilirubin ≤1.5×ULN, serum creatinine ≤1.5×ULN.
Exclusion
- refuse to sign the informed consent;
- other malignant tumors in the past 5 years or at the same time, except cured basal cell carcinoma of skin, cervical carcinoma in situ, thyroid papillary carcinoma and breast cancer without recurrence 3 years after radical resection;
- laparoscopic Fagotti score ≥6;
- extensive adhesion exists in the abdominal cavity.
- \>1cm of residual lesions in the abdominal cavity after tumor cell extinction;
- patients with previous gastrointestinal perforation, abdominal abscess or recent intestinal obstruction (within 3 months), or with imaging and clinical symptoms indicating intestinal obstruction;
- suffer from other difficult to control serious diseases, including uncontrolled hypertension, NYHA grade 2 or above heart failure, unstable angina, atrial fibrillation, myocardial infarction (within the previous 1 year), renal insufficiency, uncontrollable infection, etc.;
- significant clinically significant bleeding symptoms and abnormal coagulation function (INR\>2.0 or prothrombin time \>16s) within the previous 3 months, with a clear tendency to bleeding or being treated with thrombolysis or anticoagulant therapy;
- occurrence of thrombotic events in the past six months, such as cerebrovascular accident, deep vein thrombosis and pulmonary embolism;
- congenital or acquired immune deficiency;
- with active hepatitis, active ulcer, unhealed wound or fracture;
- being treated with other anticancer drugs;
- the investigator assessed and determined that there were any other unstable conditions, including alcohol abuse, drug abuse, other family or social factors, that might affect patient safety and compliance or cause the study to be discontinued.
Key Trial Info
Start Date :
June 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2024
Estimated Enrollment :
202 Patients enrolled
Trial Details
Trial ID
NCT04280185
Start Date
June 1 2020
End Date
May 1 2024
Last Update
May 18 2020
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
The Second Affiliated Hospital, Zhejiang University, School Of Medicine
Hangzhou, Zhejiang, China, 310009