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

Last updated: November 4, 2022
Sponsor: Women's Hospital School Of Medicine Zhejiang University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Ovarian Cysts

Recurrent Ovarian Cancer

Treatment

N/A

Clinical Study ID

NCT05607329
SCAP-3
  • Ages 18-70
  • Female

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patients with diagnosis of first-line or second-line recurrent epithelial ovariancarcinoma, peritoneal carcinoma, or fallopian tube carcinoma, who has previouslyreceived 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 theascites 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 theUpper Normal Limit
  8. No Renal insufficiency (serum creatinine < 1,5 time the normal limit, creatinineclearance > 80 mL/min). calculated with MDRD method
  9. Hematology function: PNN ≥ 1,5x10⁹/L, platelets ≥ 100x10⁹/L
  10. No contraindication to general anaesthesia for heavy surgery
  11. Patients having read, signed and dated Informed consent before any study procedure

Exclusion

Exclusion Criteria:

  1. Platinum-refractory/uncontrolled epithelial ovarian cancer;
  2. Non-epithelial ovarian tumor, mucinous, serous-mucinous (mainly mucinous), malignantBrenner tumor, low-grade serous carcinoma, borderline tumor;
  3. Suffering from other malignant tumors that have not achieved complete remission in thepast 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 ofits excipients.

Study Design

Total Participants: 400
Study Start date:
May 01, 2021
Estimated Completion Date:
May 01, 2028

Connect with a study center

  • Women's Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang 310000
    China

    Active - Recruiting

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