Cytoreductive Surgery in Platinum-resistant Recurrent Ovarian Cancer

Not Applicable

Not yet recruiting

• Conditions: Cytoreductive Surgery
• Interventions: Other: cytoreductive surgery

• Registration Number: NCT05633199
• Lead Sponsor: Women's Hospital School Of Medicine Zhejiang University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-11
• Study First Submitted: 2022-11-20
• Study First Submitted QC: 2022-11-30
• Last Update Submitted: 2022-11-30
• Study Start: 2022-12-01
• Study First Posted: 2022-12-01
• Last Update Posted: 2022-12-01
• Primary Completion: 2026-11-01
• Study Completion: 2028-01-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 140

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
cytoreduction surgery followed by chemotherapy	cytoreductive surgery	-

Primary Outcome Measures

Name	Time	Method
PFS	month 6	period from the end of treatment to the recurrence of disease

Trial Locations

Locations (1)

Women's Hospital, Zhejiang University School of Medicine; 🇨🇳 Hangzhou, China