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Trial Title:
Cytoreductive Surgery in Platinum-resistant Recurrent Ovarian Cancer
NCT ID:
NCT05633199
Condition:
Cytoreductive Surgery
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Single (Participant)
Intervention:
Intervention type:
Other
Intervention name:
cytoreductive surgery
Description:
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.
Arm group label:
cytoreduction surgery followed by chemotherapy
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.
Criteria for eligibility:
Criteria:
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.
Gender:
Female
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Women's Hospital, Zhejiang University School of Medicine
Address:
City:
Hangzhou
Country:
China
Contact:
Last name:
Junfen Xu, Dr
Phone:
0086-13567147767
Email:
xjfzu@zju.edu.cn
Facility:
Name:
Women's Hospital, Zhejiang University School of Medicine
Address:
City:
Hangzhou
Country:
China
Contact:
Last name:
Junfen Xu
Phone:
0086-13567147767
Email:
xjfzu@zju.edu.cn
Start date:
December 1, 2022
Completion date:
January 1, 2028
Lead sponsor:
Agency:
Women's Hospital School Of Medicine Zhejiang University
Agency class:
Other
Source:
Women's Hospital School Of Medicine Zhejiang University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05633199
