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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-70
SponsorWomen's Hospital School Of Medicine Zhejiang University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Relapse occurred after 6 month since platinum-based chemotherapy;

PARPi maintenance therapy for more than 6 months before relapse;

R0 ideal debulking in initial surgery;

Disqualifiers

Platinum-refractory/uncontrolled epithelial ovarian cancer;

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

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

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Secondary cytoreduction

    Procedure/Surgery

    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.

  • Chemotherapy

    Drug

    chemotherapy

Treatment groups

400 Participants
are divided into 2 treatment groups
Group A: Secondary cytoreduction followed by chemotherapyExperimental treatment 2 interventions
Group B: chemotherapy aloneActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

progression free survival (PFS)

progression free survival

Time frame
18-24 months

Secondary outcomes

Other outcomes

Sponsors and contacts

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