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Surgery Combined With Maintenance Targeted Therapy in the Treatment of Advanced Ovarian Cancer

NCT05200260 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 220

Last updated 2025-02-10

No results posted yet for this study

Summary

Optimal Timing of Surgery combined with Maintenance Therapy in the Front-line Treatment of Advanced Ovarian Cancer

Conditions

Interventions

PROCEDURE

Primary debulking surgery

Primary debulking surgery with a maximum cytoreduction, then followed by 6 cycles of Paclitaxel 175mg/m2 or Docetaxel 60-75 mg/m2 plus Carboplatin AUC (area under the curve) 5.

PROCEDURE

Neoadjuvant chemotherapy

3 cycles of Paclitaxel 175mg/m2 or Docetaxel 60-75 mg/m2 plus Carboplatin AUC (area under the curve) 5, Interval debulking surgery with a maximal cytoreduction of complete gross resection, then followed by another 3 cycles of chemotherapy.

DRUG

PARP inhibitor

For patients with BRCA mutated, maintenance therapy of PARP inhibitors following CR/PR after first-line chemotherapy. In this trial, Olaparib 300mg p.o. twice daily is suggested after the front-line therapy.

DRUG

Bevacizumab

For patients without BRCA mutated, maintenance therapy of Bevacizumab following CR/PR after first-line chemotherapy. In this trial, Bevacizumab 7.5mg per kilogram intravenous once every 3 weeks is suggested after the front-line therapy.

Sponsors & Collaborators

  • Fudan University

    collaborator OTHER

  • Shanghai Gynecologic Oncology Group

    lead OTHER_GOV

Principal Investigators

  • Libing Xiang · Fudan University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-13
Primary Completion
2027-06-30
Completion
2027-06-30

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05200260 on ClinicalTrials.gov