Secondary Cytoreduction Followed by Chemotherapy Versus Chemotherapy Alone in Relapsed Ovarian Cancer After PARPi Maintenance Treatment: a Multicentre, Open-label, Randomised, Phase 3 Trial

Relapsed Ovarian Cancer Clinical Trial

Official title:

Secondary Cytoreduction Followed by Chemotherapy Versus Chemotherapy Alone in Relapsed Ovarian Cancer After PARPi Maintenance Treatment: a Multicenter, Open-label, Randomized, Phase 3 Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05607329
• Other study ID #: SCAP-3
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2021
• Est. completion date: May 1, 2028

Study information

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

Clinical Trial Summary

This study aims to carry out a multi-center, randomized controlled study on patients with recurrent ovarian cancer after PARPi maintenance, to explore the clinicopathological and molecular characteristics of patients with recurrent ovarian cancer after PARPi maintenance, and to clarify whether patients with recurrent ovarian cancer after PARPi maintenance for more than 6 months are sensitive to platinum drugs, and the value of secondary tumor cell reduction in such treatment, In order to provide evidence-based medicine basis for the standardized treatment mode of recurrent ovarian cancer after PARPi maintenance treatment.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: May 1, 2028
• Est. primary completion date: May 1, 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Patients with diagnosis of first-line or second-line recurrent epithelial ovarian carcinoma, peritoneal carcinoma, or fallopian tube carcinoma, who has previously received at least 4 cycles of platinum-based chemotherapy in initial treatment;

2. Relapse occurred after 6 month since platinum-based chemotherapy;

3. PARPi maintenance therapy for more than 6 months before relapse;

4. R0 ideal debulking in initial surgery;

5. PET-CT indicate the recurrence lesion is isolated and not exceed 5 sites, and the ascites is less than 500ml;

6. ECOG/WHO Performance score of 0 to 1;

7. No hepatic failure, bilirubin = 1,5 time the Normal limit, ASAT and ALAT = 3 time the Upper Normal Limit

8. No Renal insufficiency (serum creatinine < 1,5 time the normal limit, creatinine clearance > 80 mL/min). calculated with MDRD method

9. Hematology function: PNN = 1,5x10?/L, platelets = 100x10?/L

10. No contraindication to general anaesthesia for heavy surgery

11. Patients having read, signed and dated Informed consent before any study procedure

Exclusion Criteria:

1. Platinum-refractory/uncontrolled epithelial ovarian cancer;

2. Non-epithelial ovarian tumor, mucinous, serous-mucinous (mainly mucinous), malignant Brenner tumor, low-grade serous carcinoma, borderline tumor;

3. Suffering from other malignant tumors that have not achieved complete remission in the past 2 years;

4. Received radiotherapy within 2 weeks before the start of the study intervention;

5. General conditions cannot tolerate secondary cytoreduction;

6. Severe hypersensitivity reactions (= grade 3) to paclitaxel or platinum and/or any of its excipients.

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Ovarian Neoplasms
• Relapsed Ovarian Cancer

Intervention

Procedure:
• Secondary cytoreduction
Open surgery is conducted by senior clinicians in gynecological oncology. Operation time,location and number of relapsed lesions, location and number of excised lesions, Whether achieved R0 or not, and other information are recorded.

Drug:
• Chemotherapy
chemotherapy

Locations

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

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	progression free survival (PFS)	progression free survival	18-24 months