Cytoreductive Surgery in Platinum-resistant Recurrent Ovarian Cancer

Study Overview
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Brief Summary
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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.

Official Title
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Cytoreductive Surgery in Platinum-resistant Recurrent Ovarian Cancer：a Randomized Controlled Study

Conditions
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Cytoreductive Surgery

Intervention / Treatment
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* Other: cytoreductive surgery


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: cytoreduction surgery followed by chemotherapy<br> | Other: cytoreductive surgery<br>* Open surgery is conducted by senior doctors in gynecological oncology. The following parameters should be recorded: period of operation, location and number of recurrent lesions, location and number of resected lesions, amount of intraoperative bleeding and blood transfusion, whether R0 is reached, size and distribution of residual lesions, surgical complications, hospital stay, and period to adjuvant chemotherapy. Patients are required to start intravenous chemotherapy within 4W after surgery, at least for 4 cycles.<br>|
| No Intervention: chemotherapy alone<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PFS | period from the end of treatment to the recurrence of disease | month 6 |