Gynecological Cancer
Conditions
Interventions
Single-arm:Hyperthermic intraperitoneal docetaxel
Sponsors
Department of Gynecologic Oncology,Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. According to the gynecology malignant tumor abdominal hot perfusion chemotherapy clinical expert consensus, with HIPEC treatment indications, including the initial treatment of ovarian cancer, recurrent ovarian cancer, peritoneum pseudo myxoma, accompanied by abdominal cavity effusion or disseminated other gynecological malignant tumors of peritoneal cavity transfer, branch caused by malignant tumors refractory peritoneal effusion, Uterine sarcoma found after the use of tumor (uterine) device, ovarian mucous tumor before or during the rupture, a large amount of mucus overflow contamination of the abdominal cavity; 2. Ages 18 to 70; 3. Serum creatinine was within the normal range (reference range of creatinine: 58-96umol/L) before receiving HIPEC, and renal function was normal; 4. No bone marrow suppression before HIPEC (considering many factors affecting hemoglobin level, including intraoperative blood loss and postoperative fluid infusion hemodilution, hemoglobin >=80g/L was set; Leukocyte >= 4.0*109/L, granulocyte >= 2.0*10^9/L; Platelet >= 100*10^9/L); 5. There was no abnormal liver function before receiving HIPEC (total bilirubin 3.4-22.2umol/L, ALT 7-40 U/L, AST 13-35U/L, AST/ALT<=1.5); 6. Signed informed consent and received docetaxel and cisplatin HIPEC treatment.
Exclusion criteria
Exclusion criteria: 1. Contraindications to HIPEC: intestinal obstruction; Extensive adhesion in peritoneal cavity; The abdominal cavity has obvious inflammation; There may be high-risk factors for poor postoperative anastomotic healing, including anastomotic tissue edema, ischemia, obvious tension, severe hypoproteinemia, etc. Dysfunction of major organs such as heart, kidneys, liver and brain; Severe coagulopathy; Bile obstruction and ureteral obstruction; 2. No history of radiotherapy or chemotherapy in recent 3 weeks; 3. In addition to HIPEC, docetaxel and cisplatin should be used by other means within 3 weeks after HIPEC treatment; 4. Those who have taken drugs that damage liver and kidney function or inhibit bone marrow within 3 months; 5. Allergic to docetaxel and cisplatin.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum tolerated dose; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of DLT (Dose limited toxicity) during 9 weeks of intraperitoneal thermoinfusion of docetaxel;Effect of dose on tumor control rate; | — |
Countries
China
Contacts
Public ContactZhongqiu Lin
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Outcome results
None listed