Personalized Timing of Interval Debulking Surgery in Advanced Ovarian Cancer

NCT07023484 | Recruiting Phase 2 DMC

• 2 other identifiers: UW 24-746HKUCTR-3092
• Study Type: interventional
• Target: 126
• Locations: 2 countries
• Sites: 6

Brief Summary

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.

Conditions

Ovarian Cancer; Fallopian Tube Cancer; Primary Peritoneal Carcinoma

Keywords

advanced; ovarian cancer; fallopian tube cancer; primary peritoneal cancer; neoadjuvant chemotherapy; interval debulking surgery; kelim

Outcome Measures

Primary Outcomes (2)

• Complete resection (CC0) rate

  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

  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 Outcomes (5)

• Chemotherapy response score (CRS)

  up to 24 weeks from randomisation

• Progression-free survival (PFS) by RECIST criteria

  up to 5 years from randomisation

• Overall survival (OS)

  Up to 5 years from randomisation

• Incidence of adverse events

  up to 1 year from randomisation

• Quality-of-life scale

  up to 1 year from randomisation

Other Outcomes (1)

• Expression of biomarkers

  up to 1 year from randomisation

Study Arms (2)

Standard clinical practice

ACTIVE COMPARATOR

Participants will follow the standard practice and receive 3-6 cycles of neoadjuvant chemotherapy, followed by radiological assessment and interval debulking surgery.

Drug: Carboplatin plus Paclitaxel; Procedure: Interval debulking surgery

Personalised management

EXPERIMENTAL

Patients will be managed based on CA-125 ELIMination Rate Constant K (KELIM) at the neoadjuvant setting.

Diagnostic Test: KELIM; Drug: Carboplatin plus Paclitaxel; Procedure: Interval debulking surgery

Interventions

KELIM DIAGNOSTIC_TEST

(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

Personalised management

Carboplatin plus Paclitaxel DRUG

Neoadjuvant chemotherapy

Personalised management; Standard clinical practice

Interval debulking surgery PROCEDURE

Interval debulking surgery

Personalised management; Standard clinical practice

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Patients who have baseline computed tomography (CT) of thorax, abdomen and pelvis.
• 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.
• Patients who have an evaluable CA125 level at baseline (i.e., baseline level is at least 2x upper limit of normal)
• Patients who agree for chemotherapy and interval debulking surgery (IDS) if the disease becomes operable after NACT
• Patients with adequate hematologic, liver and renal functions for chemotherapy
• 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.
• Patients who have childbearing potential should practice highly effective contraception throughout the study until at least 30 days after completion of the treatment.
• Patients must have either germline and / or somatic BRCA test, or homologous recombination deficiency (HRD) test.

You may not qualify if:

• 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)
• Patients who cannot undergo PDS because of parametrial and/or vaginal involvement alone
• Patients who are not fit for PDS because of medical morbidities or refusal of operation
• 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
• Patients who participate in other interventional studies
• Patients who are pregnant or breastfeeding
• Patients who have contraindications to platinum-based chemotherapy
• Patents with active tuberculosis, history of positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS) are excluded.

Sponsors & Collaborators

• The University of Hong Kong: lead
• 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 Centre: collaborator

Study Sites (6)

Sun Yat-sen University Cancer Center

Guangzhou, China

NOT YET RECRUITING

The University of Hong Kong - Shenzhen Hospital

Shenzhen, China

NOT YET RECRUITING

Pamela Youde Nethersole Eastern HospitalPamela Y

Chai Wan, Hong Kong

NOT YET RECRUITING

Queen Mary Hospital, Department of Clinical Oncology

Hong Kong, Hong Kong

NOT YET RECRUITING

The University of Hong Kong, Department of Obstetrics and Gynaecology

Hong Kong, Hong Kong

RECRUITING

United Christian Hospital

Kwun Tong, Hong Kong

NOT YET RECRUITING

MeSH Terms

Conditions

Ovarian Neoplasms; Fallopian Tube Neoplasms

Interventions

Carboplatin; Paclitaxel

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Fallopian Tube Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes

Study Officials

• Ka Yu Tse, MBBS, MMedSc, PhD, FRCOG

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lesley Lau, MPhil

CONTACT

+852 22554265; lsk382@hku.hk

Iris Tang

CONTACT

+852 22554265; iristwk@hku.hk

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Completeness of resection is assessed by independent surgeon
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Model Details: non-inferiority randomised trial

Study Record Dates

• First Submitted: June 7, 2025
• First Posted: June 17, 2025
• Study Start: May 22, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: July 2, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

HK (4); CN (2)