Personalised Timing of Interval Debulking Surgery in Advanced Ovarian Cancer

NCT ID: NCT07022535

Last Updated: 2025-07-02

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-28
• Study Completion Date: 2025-12-31

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.

Detailed Description

Recruited patients will have additional CA125 at 4th (before administration of chemotherapy), and 5th week after the first cycle of chemotherapy. CA-125 ELIMination Rate Constant K (KELIM) will be determined. 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

Conditions

Ovarian Cancer; Fallopian Tube Cancer; Peritoneal Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Personalised management

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

Group Type: EXPERIMENTAL

KELIM

Intervention Type: 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

Carboplatin plus Paclitaxel

Intervention Type: DRUG

Chemotherapy as neaodjuvant chemotherapy

Interval debulking surgery

Intervention Type: PROCEDURE

Interval debulking surgery

Interventions

KELIM

(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

Intervention Type: DIAGNOSTIC_TEST

Carboplatin plus Paclitaxel

Chemotherapy as neaodjuvant chemotherapy

Intervention Type: DRUG

Interval debulking surgery

Interval debulking surgery

Intervention Type: PROCEDURE

Other Intervention Names

cytoreductive surgery

Eligibility Criteria

Inclusion Criteria

1. Patients must be at least 18 years old.

2. Patients who have Eastern Cooperative Oncology Group (ECOG) score 0-1.

3. Patients who are competent to give informed consent.

4. 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).

5. 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.

6. Patients who have an evaluable CA125 level at baseline (i.e., baseline level is at least 2x upper limit of normal).

7. 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.

8. Patients who agree to undergo IDS, where the time of IDS may differ from the usual clinical practice.

9. Patients who agree to receive adjuvant chemotherapy, if clinically indicated. The total number of chemotherapy should be at least four or above.

Exclusion Criteria

1. 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

2. Patients who are eligible for PDS

3. Patients who are not fit for PDS because of medical morbidities or refusal of operation

4. 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.

5. Patients who are pregnant

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

The University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Dr. Ka-Yu Tse

Prof.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ka Yu Tse, MBBS, MMedSc, PhD, FRCOG

Role: PRINCIPAL_INVESTIGATOR

The University of Hong Kong

Locations

The University of Hong Kong

Hong Kong, , Hong Kong

Site Status: RECRUITING

Countries

Hong Kong

Central Contacts

Lesley Lau, MPhil

Role: CONTACT

lsk382@hku.hk

+852 22554265

Iris Tang

Role: CONTACT

iristwk@hku.hk

+852 22554265

Facility Contacts

Lesley Lau, MPhil

Role: primary

lsk382@hku.hk

+852 22554265

Iris Tang

Role: backup

iristwk@hku.hk

+852 22554265

Other Identifiers

HKUCTR-3091

Identifier Type: REGISTRY

Identifier Source: secondary_id

UW 24-304

Identifier Type: -

Identifier Source: org_study_id