Actively Recruiting
Personalized Timing of Interval Debulking Surgery in Advanced Ovarian Cancer
Led by The University of Hong Kong · Updated on 2025-07-02
126
Participants Needed
6
Research Sites
188 weeks
Total Duration
On this page
Sponsors
T
The University of Hong Kong
Lead Sponsor
Q
Queen Mary Hospital, Hong Kong
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Personalized Timing of Interval Debulking Surgery in Advanced Ovarian Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 18 years old or older
- Eastern Cooperative Oncology Group score of 0-1 within 28 days prior to recruitment
- Ability to sign informed consent
- Stage III-IV histologically or cytologically confirmed epithelial ovarian, fallopian tube, or primary peritoneal cancer not suitable for primary debulking surgery
- Baseline CT scan of thorax, abdomen, and pelvis
- Planned neoadjuvant chemotherapy with 3-weekly carboplatin and paclitaxel or one cycle completed with aligned CA125 schedule
- Baseline CA125 level at least twice the upper limit of normal
- Agreement to chemotherapy and interval debulking surgery if operable after chemotherapy
- Adequate blood, liver, and kidney function for chemotherapy
- Agreement to receive adjuvant chemotherapy after surgery, totaling 4 to 9 cycles
- Use of highly effective contraception if of childbearing potential during study and 30 days after treatment
- Completed germline and/or somatic BRCA or homologous recombination deficiency testing
You will not qualify if you...
- Borderline malignancy, non-epithelial ovarian cancer such as germ cell or sex cord tumors, or metastatic cancer from other origins
- Mucinous or neuroendocrine tumor types
- History of other cancers within the past five years
- Eligible for primary debulking surgery
- Surgery not possible due to parametrial or vaginal involvement alone
- Medically unfit or refusal to undergo primary debulking surgery
- Started neoadjuvant chemotherapy outside study centers except one cycle within 7 days with available baseline CA125
- Participation in other interventional studies
- Pregnant or breastfeeding
- Contraindications to platinum-based chemotherapy
- Active tuberculosis, HIV positive, or AIDS diagnosis
AI-Screening
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Trial Site Locations
Total: 6 locations
1
Sun Yat-sen University Cancer Center
Guangzhou, China
Not Yet Recruiting
2
The University of Hong Kong - Shenzhen Hospital
Shenzhen, China
Not Yet Recruiting
3
Pamela Youde Nethersole Eastern HospitalPamela Y
Chai Wan, Hong Kong
Not Yet Recruiting
4
Queen Mary Hospital, Department of Clinical Oncology
Hong Kong, Hong Kong
Not Yet Recruiting
5
The University of Hong Kong, Department of Obstetrics and Gynaecology
Hong Kong, Hong Kong
Actively Recruiting
6
United Christian Hospital
Kwun Tong, Hong Kong
Not Yet Recruiting
Research Team
L
Lesley Lau, MPhil
CONTACT
I
Iris Tang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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