Menu
Recruiting NCT05607329

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

No phase Interventional Relapsed Ovarian Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Secondary cytoreduction, Chemotherapy.
Who it may be relevant to
Registry conditions: Relapsed Ovarian Cancer. Basic parameters: 18 years — 70 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

  • 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

Primary outcome measures

  • progression free survival (PFS) [Time frame: 18-24 months]

Eligibility criteria

Inclusion criteria

  • 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;
  • PET-CT indicate the recurrence lesion is isolated and not exceed 5 sites, and the ascites is less than 500ml;
  • ECOG/WHO Performance score of 0 to 1;
  • No hepatic failure, bilirubin ≤ 1,5 time the Normal limit, ASAT and ALAT ≤ 3 time the Upper Normal Limit
  • No Renal insufficiency (serum creatinine < 1,5 time the normal limit, creatinine clearance > 80 mL/min). calculated with MDRD method
  • Hematology function: PNN ≥ 1,5x10⁹/L, platelets ≥ 100x10⁹/L
  • No contraindication to general anaesthesia for heavy surgery
  • Patients having read, signed and dated Informed consent before any study procedure

Exclusion criteria

  • 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;
  • General conditions cannot tolerate secondary cytoreduction;
  • Severe hypersensitivity reactions (≥ grade 3) to paclitaxel or platinum and/or any of its excipients.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Women's Hospital, Zhejiang University School of Medicine — Hangzhou

Publications

  • Chen T, Xu J, Xia B, Wang H, Shen Y. Secondary cytoreduction surgery for recurrent epithelial ovarian cancer patients after PARPi maintenance: A multicenter, randomized, controlled clinical trial. Int J Gynecol Cancer. 2024 Feb 5;34(2):328-331. doi: 10.1136/ijgc-2023-004978. PMID 38159938

Identifiers

NCT: NCT05607329 · SCAP-3

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗