NCT05607329

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
24mo left

Started May 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress72%
May 2021May 2028

Study Start

First participant enrolled

May 1, 2021

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

November 2, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 7, 2022

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2028

Expected
Last Updated

November 7, 2022

Status Verified

January 1, 2022

Enrollment Period

5 years

First QC Date

November 2, 2022

Last Update Submit

November 4, 2022

Conditions

Relapsed Ovarian Cancer

Outcome Measures

Primary Outcomes (1)

  • progression free survival (PFS)

    progression free survival

    18-24 months

Study Arms (2)

Secondary cytoreduction followed by chemotherapy

EXPERIMENTAL
Procedure: Secondary cytoreductionDrug: Chemotherapy

chemotherapy alone

ACTIVE COMPARATOR
Drug: Chemotherapy

Interventions

Secondary cytoreductionPROCEDURE

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.

Secondary cytoreduction followed by chemotherapy
ChemotherapyDRUG

chemotherapy

Secondary cytoreduction followed by chemotherapychemotherapy alone

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Women's Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310000, China

RECRUITING

Related Publications (1)

  • 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: 38159938DERIVED

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

Drug Therapy

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 2, 2022

First Posted

November 7, 2022

Study Start

May 1, 2021

Primary Completion

May 1, 2026

Study Completion (Estimated)

May 1, 2028

Last Updated

November 7, 2022

Record last verified: 2022-01

Locations

CN(1)