Cytoreductive Surgery
Conditions
Brief 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.
Interventions
OTHERcytoreductive surgery
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.
Sponsors
Women's Hospital School Of Medicine Zhejiang University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Patients with diagnosis of epithelial ovarian carcinoma, peritoneal carcinoma, or fallopian tube carcinoma within 3 lines recurrence; 2. Recurrence occurred within 6 months since platinum-based chemotherapy; 3. 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; 4. ECOG/WHO Performance score of 0 to 1; 5. Hematology function: Leukocyte≥ 3,5x10⁹/L, neutrophil≥ 1,5x10⁹/L, platelets ≥ 100x10⁹/L; 6. No Renal insufficiency: serum creatinine \< 1,5 time the normal limit, creatinine clearance \> 60 mL/min; 7. No hepatic failure: bilirubin ≤ 1,5 time the Normal limit; 8. Patients with good compliance; 9. Patients having read, signed and dated Informed consent before any study procedure.
Exclusion criteria
1. Platinum-refractory/uncontrolled epithelial ovarian cancer; 2. Mucous carcinoma or low-grade serous carcinoma; 3. Suffering from other malignant tumors that have not achieved complete remission in the past 2 years; 4. Patients have received abdominal or pelvic radiotherapy; 5. General conditions cannot tolerate cytoreduction; 6. Severe hypersensitivity reactions (≥ grade 3) to paclitaxel or platinum and/or any of its excipients; 7. Unable or unwilling to sign the informed consent form; 8. Patients judged by the investigator to be unlikely to follow the research steps, restrictions and requirements.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PFS | month 6 | period from the end of treatment to the recurrence of disease |
Countries
China
Outcome results
None listed