Cytoreductive Surgery in Platinum-resistant Recurrent Ovarian Cancer

Cytoreductive Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05633199
• Other study ID #: CSPROC
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 1, 2022
• Est. completion date: January 1, 2028

Study information

• Verified date: November 2022
• Source: Women's Hospital School Of Medicine Zhejiang University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 140
• Est. completion date: January 1, 2028
• Est. primary completion date: November 1, 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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= 3,5x10?/L, neutrophil= 1,5x10?/L, platelets = 100x10?/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.

Related Conditions & MeSH terms

• Cytoreductive Surgery

Intervention

Other:
• cytoreductive 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.

Locations

Country	Name	City	State
China	Women's Hospital, Zhejiang University School of Medicine	Hangzhou
China	Women's Hospital, Zhejiang University School of Medicine	Hangzhou

Sponsors (1)

Lead Sponsor	Collaborator
Women's Hospital School Of Medicine Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PFS	period from the end of treatment to the recurrence of disease	month 6