Personalized Timing of Interval Debulking Surgery in Advanced Ovarian Cancer (Preselect-1)

June 29, 2025 updated by: Dr. Ka-Yu Tse, The University of Hong Kong

Personalized Timing of Interval Debulking Surgery Based on KELIM After Neoadjuvant Chemotherapy in Advanced Ovarian Cancer - a Multicenter Randomized Phase II Non-inferiority Trial (PRESELECT-I 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Recruited patients will be randomised into two groups. The control group will receive treatment according to the standard clinical practice. The investigation group will have an additional CA125 at the 5th week after the first cycle of chemotherapy. CA-125 ELIMination Rate Constant K (KELIM) will be determined using online tool. Patients with KELIM =>1 will receive radiological assessment and undergo internal debulking surgery if the disease is operable. Patients with KELIM <1 will have alternative management, such as addition of bevacizumab or changing to dose-dense chemotherapy, and defer the interval debulking surgery.

Study Type

Interventional

Enrollment (Estimated)

126

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Lesley Lau, MPhil
  • Phone Number: +852 22554265
  • Email: lsk382@hku.hk

Study Contact Backup

Study Locations

  • China
      • Guangzhou, China
        • Not yet recruiting
        • Sun Yat-sen University Cancer Center
        • Principal Investigator:
          • Jihong Liu, MD
        • Contact:
      • Shenzhen, China
        • Not yet recruiting
        • The University of Hong Kong - Shenzhen Hospital
        • Principal Investigator:
          • Li Zhang, MD
        • Contact:
  • Hong Kong
      • Chai Wan, Hong Kong
        • Not yet recruiting
        • Pamela Youde Nethersole Eastern HospitalPamela Y
        • Contact:
          • Sung Inda Soong, MBChB, FRCR
          • Phone Number: +852 97194300
          • Email: soongs@ha.org.hk
        • Principal Investigator:
          • Sung Inda Soong, MBChB, FRCR
      • Hong Kong, Hong Kong
        • Not yet recruiting
        • Queen Mary Hospital, Department of Clinical Oncology
        • Contact:
          • Steven Siu, MBBS, FRCR
          • Phone Number: +852 22554202
          • Email: siuwk@ha.org.hk
        • Sub-Investigator:
          • Steven Siu, MBBS, FRCR
      • Hong Kong, Hong Kong
        • Recruiting
        • The University of Hong Kong, Department of Obstetrics and Gynaecology
        • Contact:
          • Lesley Lau, MPhil
          • Phone Number: +852 22554265
          • Email: lsk382@hku.hk
        • Contact:
        • Principal Investigator:
          • Ka Yu Tse, MBBS, MMedSc, PhD, FRCOG
      • Kwun Tong, Hong Kong
        • Not yet recruiting
        • United Christian Hospital
        • Contact:
        • Principal Investigator:
          • Victoria Chai, MBBS, FHKCOG

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Patients aged 18 years old or older
  2. Patients with Eastern Cooperative Oncology Group score 0-1 within 28 days prior to recruitment
  3. Patients who can sign the informed consent
  4. Patients with stage III-IV histologically or cytologically confirmed epithelial ovarian cancer (EOC), fallopian tube or primary peritoneal cancer not amenable for PDS
  5. Patients who have baseline computed tomography (CT) of thorax, abdomen and pelvis.
  6. Patients who are planned for neoadjuvant chemotherapy (NACT) using 3-weekly carboplatin and paclitaxel. Those who have received one cycle of NACT may be eligible if the CA125 schedule of the study group can be matched.
  7. Patients who have an evaluable CA125 level at baseline (i.e., baseline level is at least 2x upper limit of normal)
  8. Patients who agree for chemotherapy and interval debulking surgery (IDS) if the disease becomes operable after NACT
  9. Patients with adequate hematologic, liver and renal functions for chemotherapy
  10. Patients who agree to receive adjuvant chemotherapy after IDS. The total number of NACT and adjuvant chemotherapy should be four or above, up to maximum of 9 cycles.
  11. Patients who have childbearing potential should practice highly effective contraception throughout the study until at least 30 days after completion of the treatment.
  12. Patients must have either germline and / or somatic BRCA test, or homologous recombination deficiency (HRD) test.

Exclusion Criteria:

  1. Patients who have borderline malignancy, or non-EOC like germ cell or sex cord tumor, or metastatic diseases from other origins
  2. Patients with mucinous and neuroendocrine histology
  3. Patients with history of other malignancies within five years
  4. Patients who are eligible for primary debulking surgery (PDS)
  5. Patients who cannot undergo PDS because of parametrial and/or vaginal involvement alone
  6. Patients who are not fit for PDS because of medical morbidities or refusal of operation
  7. Patients who have already started NACT outside the study centers, except those who have received only one cycle within 7 days and the baseline CA125 value within 3 days of NACT (normal cut-off 35 U/ml) is available
  8. Patients who participate in other interventional studies
  9. Patients who are pregnant or breastfeeding
  10. Patients who have contraindications to platinum-based chemotherapy
  11. Patents with active tuberculosis, history of positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS) are excluded.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard clinical practice
Participants will follow the standard practice and receive 3-6 cycles of neoadjuvant chemotherapy, followed by radiological assessment and interval debulking surgery.
Procedure: Interval debulking surgery
Interval debulking surgery
Drug: Carboplatin plus Paclitaxel
Neoadjuvant chemotherapy
Experimental: Personalised management
Patients will be managed based on CA-125 ELIMination Rate Constant K (KELIM) at the neoadjuvant setting.
Procedure: Interval debulking surgery
Interval debulking surgery
Diagnostic test: KELIM
(i) Patients with KELIM =>1 will receive radiological assessment and undergo internal debulking surgery if the disease is operable. (ii) Patients with KELIM <1 will have alternative management, such as addition of bevacizumab or changing to dose-dense chemotherapy, and defer the interval debulking surgery
Drug: Carboplatin plus Paclitaxel
Neoadjuvant chemotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete resection (CC0) rate
Time Frame: up to 24 weeks from randomisation
The likelihood of CC0 in patients who undergo IDS when KELIM reaches >=1
up to 24 weeks from randomisation
12-month progression-free survival (PFS) rate by RECIST criteria
Time Frame: up to 24 months from randomisation
PFS is defined as the time from the date of randomization until the date of progressive disease or death (whichever comes first).
up to 24 months from randomisation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of adverse events
Time Frame: up to 1 year from randomisation
The complication rates of surgery based on the Clavien-Dindo classification and chemotherapy based on the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)
up to 1 year from randomisation
Quality-of-life scale
Time Frame: up to 1 year from randomisation
Different functional scales will be assessed by questionnaires like the EORTC questionnaires where all scales range from 0-100. The higher the score, the greater the intensity of that particular item is.
up to 1 year from randomisation
Chemotherapy response score (CRS)
Time Frame: up to 24 weeks from randomisation
CRS of omentum removed during interval debulking surgery CRS 1, there is no or minimal tumor response; CRS 2, there is appreciable tumor response amidst viable tumor; CRS 3, there is complete or near complete response with no residual tumor or minimal irregularly scattered tumor foci seen as individual cells, cell groups or nodules up to 2 mm
up to 24 weeks from randomisation
Progression-free survival (PFS) by RECIST criteria
Time Frame: up to 5 years from randomisation
PFS is defined as the time from the date of randomization until the date of progressive disease or death (whichever comes first).
up to 5 years from randomisation
Overall survival (OS)
Time Frame: Up to 5 years from randomisation
OS is defined as the time from the date of randomization until death due to any cause.
Up to 5 years from randomisation

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Expression of biomarkers
Time Frame: up to 1 year from randomisation
Expression levels of biomarkers before and after chemotherapy
up to 1 year from randomisation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Hong Kong

Collaborators

Queen Mary Hospital, Hong Kong
Pamela Youde Nethersole Eastern Hospital
The University of Hong Kong-Shenzhen Hospital
United Christian Hospital
Sun Yat-sen University Cancer Centre

Investigators

  • Principal Investigator: Ka Yu Tse, MBBS, MMedSc, PhD, FRCOG, The University of Hong Kong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 22, 2025

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

June 7, 2025

First Submitted That Met QC Criteria

June 7, 2025

First Posted (Actual)

June 17, 2025

Study Record Updates

Last Update Posted (Actual)

July 2, 2025

Last Update Submitted That Met QC Criteria

June 29, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UW 24-746
  • HKUCTR-3092 (Registry Identifier: HKU Clinical Trials Registry)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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