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NCT05633199
Cytoreductive Surgery in Platinum-resistant Recurrent Ovarian Cancer
Conditions: Cytoreductive Surgery
Sex: Female
Ages: 18 Years – 70 Years
Phase: NA
Enrollment: 140
Sponsor: Women's Hospital School Of Medicine Zhejiang University
Location: China
Summary
This novel study was specifically designed for platinum-resistant recurrent ovarian cancers with PFI<6 months and aimed to compare prognosis of patients who received cytoreductive surgery followed by chemotherapy versus chemotherapy alone.
Eligibility Criteria
Inclusion Criteria:Patients with diagnosis of epithelial ovarian carcinoma, peritoneal carcinoma, or fallopian tube carcinoma within 3 lines recurrence;Recurrence occurred within 6 months since platinum-based chemotherapy;R0 ideal debulking in initial surgery; PET-CT indicate the recurrence lesion is almost in abdominal cavity, which is isolated and not exceed 5 sites, and the ascites is less than 500ml;ECOG/WHO Performance score of 0 to 1;Hematology function: Leukocyte≥ 3,5x10⁹/L, neutrophil≥ 1,5x10⁹/L, platelets ≥ 100x10⁹/L;No Renal insufficiency: serum creatinine < 1,5 time the normal limit, creatinine clearance > 60 mL/min;No hepatic failure: bilirubin ≤ 1,5 time the Normal limit;Patients with good compliance;Patients having read, signed and dated Informed consent before any study procedure.Exclusion Criteria:Platinum-refractory/uncontrolled epithelial ovarian cancer;Mucous carcinoma or low-grade serous carcinoma;Suffering from other malignant tumors that have not achieved complete remission in the past 2 years;Patients have received abdominal or pelvic radiotherapy;General conditions cannot tolerate cytoreduction;Severe hypersensitivity reactions (≥ grade 3) to paclitaxel or platinum and/or any of its excipients;Unable or unwilling to sign the informed consent form;Patients judged by the investigator to be unlikely to follow the research steps, restrictions and requirements.
Source: ClinicalTrials.gov (NCT05633199). StuddyBuddy aggregates publicly available trial information.