Personalised Timing of Interval Debulking Surgery in Advanced Ovarian Cancer

NCT07022535 | Recruiting Phase 2

• 2 other identifiers: UW 24-304HKUCTR-3091
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Ovarian Cancer; Fallopian Tube Cancer; Peritoneal Cancer

Keywords

advanced; ovarian cancer; neoadjuvant chemotherapy; interval debulking surgery; KELIM; CA 125

Outcome Measures

Primary Outcomes (2)

• Complete resection (CC0) rate

  The likelihood of CC0 in patients who undergo IDS when KELIM reaches 1 or above

  Up to 24 months

• Sensitivity of KELIM in predicting CC0

  The sensitivity of KELIM in predicting CC0

  Up to 24 weeks

Secondary Outcomes (3)

• Time required to achieve KELIM >=1

  Up to 24 weeks

• Complication rates of treatment

  Up to 1 year

• Quality-of-life scale

  Up to 1 year

Other Outcomes (1)

• Expression of biomarkers

  Up to 1 year

Study Arms (1)

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 interval 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

Chemotherapy as neaodjuvant chemotherapy

Personalised management

Interval debulking surgery PROCEDURE

Interval debulking surgery

Also known as: cytoreductive surgery

Personalised management

Eligibility Criteria

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

You may qualify if:

• Patients must be at least 18 years old.
• Patients who have Eastern Cooperative Oncology Group (ECOG) score 0-1.
• Patients who are competent to give informed consent.
• Patients who have stage III-IV histologically or cytologically confirmed epithelial ovarian cancer, fallopian tube or primary peritoneal cancer not amenable for primary debulking surgery (PDS).
• Patients who are planned for neoadjuvant chemotherapy (NACT) using platinum-based chemotherapy +/- bevacizumab or biosimilar. Those who are receiving NACT before interval debulking surgery (IDS) are also eligible.
• Patients who have an evaluable CA125 level at baseline (i.e., baseline level is at least 2x upper limit of normal).
• Patients who have baseline computed tomography of at least abdomen and pelvis, or positron emission tomography (PET)-CT. Magnetic resonance imaging (MRI) is also acceptable but the same modality has to be used when assessing the feasibility of IDS.
• Patients who agree to undergo IDS, where the time of IDS may differ from the usual clinical practice.
• Patients who agree to receive adjuvant chemotherapy, if clinically indicated. The total number of chemotherapy should be at least four or above.

You may not qualify if:

• Patients who have borderline malignancy, or non-epithelial ovarian cancer like germ cell or sex cord tumor, or metastatic diseases from other origins like Krukenberg's tumor
• Patients who are eligible for PDS
• Patients who are not fit for PDS because of medical morbidities or refusal of operation
• Patients who have already started NACT outside the study centres, except those who have just had one cycle within 21 days and the baseline CA125 is available.
• Patients who are pregnant

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

The University of Hong Kong

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Ovarian Neoplasms; Fallopian Tube Neoplasms

Interventions

Carboplatin; Paclitaxel; Cytoreduction Surgical Procedures

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; Surgical Procedures, Operative

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: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Model Details: Pilot study, single-arm

Study Record Dates

• First Submitted: June 6, 2025
• First Posted: June 15, 2025
• Study Start: May 28, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: July 2, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: One year after the end of the study
• Access Criteria: The study protocol will be available under a reasonable request to the corresponding author

Locations

HK (1)