Cytoreductive Surgery in Platinum-resistant Recurrent Ovarian Cancer

Women's Hospital School Of Medicine Zhejiang University

Status: Not yet enrolling

Conditions: Cytoreductive Surgery

Treatments: Other: cytoreductive surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT05633199

CSPROC

Details and patient eligibility

About

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.

Enrollment: 140 estimated patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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140 participants in 2 patient groups

cytoreduction surgery followed by chemotherapy

Experimental group

Treatment:

Other: cytoreductive surgery

chemotherapy alone

No Intervention group