Surgery for recurrent ovarian cancer after chemotherapy
Secondary Neoadjuvant Chemotherapy and Interval Cytoreductive Surgery in Platinum-sensitive Recurrent Epithelial Ovarian Cancer Patients - a Pilot Study
NA · The University of Hong Kong · NCT06292286
This study tests if a specific type of surgery after chemotherapy can help women with recurrent ovarian cancer live longer and feel better.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 18 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | The University of Hong Kong (other) |
| Drugs / interventions | bevacizumab, chemotherapy |
| Locations | 1 site (Hong Kong) |
| Trial ID | NCT06292286 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of secondary interval cytoreductive surgery in patients with recurrent epithelial ovarian cancer who have responded to platinum-based chemotherapy. It aims to determine the rate of complete tumor resection and assess the safety and survival outcomes associated with this surgical approach. The study involves administering chemotherapy agents such as carboplatin, paclitaxel, and bevacizumab, followed by surgical intervention for eligible patients. The goal is to improve treatment outcomes for those with recurrent ovarian cancer.
Who should consider this trial
Good fit: Ideal candidates include women with histologically confirmed epithelial ovarian cancer who have had a platinum-free interval of at least six months and an ECOG performance score of 0 to 2.
Not a fit: Patients with non-epithelial tumors, concurrent malignancies, or those who have undergone multiple lines of chemotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved survival rates and quality of life for patients with recurrent ovarian cancer.
How similar studies have performed: While the specific approach of secondary interval cytoreductive surgery is being evaluated, similar studies have shown promising results in improving outcomes for selected patients with recurrent ovarian cancer.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Histologically diagnosed EOC, fallopian tube or primary peritoneal carcinoma * \>= 3 cycles of platinum-based chemotherapy, with or without bevacizumab and / or PARPi, at primary setting * Platinum-free interval should be \>=6 months from the last dose of platinum-based chemotherapy * Upfront SCR not feasible * Patients should have Eastern Cooperative Oncology Group (ECOG) performance score 0 to 2 within 28 days prior to recruitment. * Patients must have adequate bone marrow, renal, hepatic and neurological function within 28 days prior to the start of treatment. Exclusion Criteria: * Non-epithelial or borderline tumors are excluded * Patients who have with concurrent malignancy within five years (except for basal or squamous cell skin cancer, in-situ breast cancer, stage 1a grade 1-2 endometrioid endometrial carcinoma without lymphovascular invasion) are excluded. * Patients using more than one line of chemotherapy are excluded. * Patients who have platinum-resistant or refractory recurrence are excluded. * Patients having second relapse or beyond are excluded. * Patients who have contraindications to operation, e.g., unresolved thrombocytopenia, bowel obstruction in the last 4 weeks prior to enrolment
Where this trial is running
Hong Kong
- The University of Hong Kong — Hong Kong, Hong Kong (RECRUITING)
Study contacts
- Principal investigator: Ka Yu Tse — The University of Hong Kong
- Study coordinator: Lesley Lau
- Email: lsk382@hku.hk
- Phone: 852-22554265
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Recurrent Ovarian Carcinoma