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Recruiting NCT07022535

Personalised Timing of Interval Debulking Surgery in Advanced Ovarian Cancer

Phase II Interventional Ovarian Cancer Fallopian Tube Cancer Peritoneal Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: KELIM, Carboplatin plus Paclitaxel, Interval debulking surgery.
Who it may be relevant to
Registry conditions: Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Cancer. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Hong Kong
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Personalised Timing of Interval Debulking Surgery Based on KELIM After Neoadjuvant Chemotherapy in Advanced Ovarian Cancer - a Pilot Study

Overview

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

Interventions

  • Diagnostic test 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
  • Drug Carboplatin plus Paclitaxel
    Chemotherapy as neaodjuvant chemotherapy
  • Procedure Interval debulking surgery
    Interval debulking surgery

Primary outcome measures

  • Complete resection (CC0) rate [Time frame: Up to 24 months]
  • Sensitivity of KELIM in predicting CC0 [Time frame: Up to 24 weeks]
Secondary outcome measures (3)
  • Time required to achieve KELIM >=1 [Time frame: Up to 24 weeks]
  • Complication rates of treatment [Time frame: Up to 1 year]
  • Quality-of-life scale [Time frame: Up to 1 year]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Hong Kong · 1 center
  • The University of Hong Kong — Hong Kong

Identifiers

NCT: NCT07022535 · UW 24-304 · HKUCTR-3091

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗