Personalized Timing of Interval Debulking Surgery in Advanced Ovarian Cancer

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18+
SponsorThe University of Hong Kong

About this trial

About 70% of epithelial ovarian cancer patients are diagnosed at advanced stage. When primary optimal surgery is not possible, neoadjuvant chemotherapy will followed by interval debulking surgery is one treatment option. However, there is no consensus on the optimal timing of the surgery. CA125 is a well-known tumor marker in ovarian cancer. Its kinetic change has been proven to correlate with the patients' response to chemotherapy and chance of optimal resection. This study aims to utilize the kinetic change of CA125 to customize the timing of surgery for individual patients and compare this with the standard clinical practice.

Eligibility criteria

Qualifiers

Patients aged 18 years old or older

Patients with Eastern Cooperative Oncology Group score 0-1 within 28 days prior to recruitment

Patients who can sign the informed consent

Patients with stage III-IV histologically or cytologically confirmed epithelial ovarian cancer (EOC), fallopian tube or primary peritoneal cancer not amenable for PDS

Disqualifiers

Patients who have borderline malignancy, or non-EOC like germ cell or sex cord tumor, or metastatic diseases from other origins

Patients with mucinous and neuroendocrine histology

Patients with history of other malignancies within five years

Patients who are eligible for primary debulking surgery (PDS)

Trial design

Treatments tested in this trial

  • KELIM
  • Carboplatin plus Paclitaxel
  • Interval debulking surgery

Treatment groups

126 Participants
are divided into 2 treatment groups

Sponsors and collaborators

The University of Hong Kong

Lead sponsor

Queen Mary Hospital, Hong Kong

Collaborator

United Christian Hospital

Collaborator

Pamela Youde Nethersole Eastern Hospital

Collaborator

The University of Hong Kong-Shenzhen Hospital

Collaborator

Sun Yat-Sen University Cancer Center

Collaborator