Secondary Interval Cytoreductive Surgery in Platinum-sensitive Recurrent Epithelial Ovarian 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: Carboplatin or cisplatin, Paclitaxel, gemcitabine or liposomal doxorubicin with or without bevacizumab or biosimilar, Bevacizumab or biosimilar, Cytoreductive surgery.
- Who it may be relevant to
- Registry conditions: Recurrent Ovarian Carcinoma. 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 →
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Official title
Secondary Neoadjuvant Chemotherapy and Interval Cytoreductive Surgery in Platinum-sensitive Recurrent Epithelial Ovarian Cancer Patients - a Pilot Study
Overview
About 80% of advanced ovarian cancer patients recurred in 2-3 years. Secondary cytoreduction benefits selected patients who have high chance of complete resection. Whether secondary interval surgery can be used at recurrence is not known.
Detailed description
Our study aims to evaluate the complete resection rate at interval cytoreductive surgery for recurrent ovarian cancer patients, and to determine the safety and survival outcomes of this approach.
Interventions
- Procedure Carboplatin or cisplatin
Carboplatin of cisplatin for 3-6 cycles - Drug Paclitaxel, gemcitabine or liposomal doxorubicin with or without bevacizumab or biosimilar
Paclitaxel, gemcitabine or liposomal doxorubicin, for 3-6 cycles - Drug Bevacizumab or biosimilar
Optional - Procedure Cytoreductive surgery
Cytoreductive surgery after chemotherapy
Primary outcome measures
- Complete resection rate [Time frame: 12 months]
Secondary outcome measures (4)
- 12-month progression-free survival rate [Time frame: 12 months]
- 12-month overall survival rate [Time frame: 12 months]
- Surgical complication rate [Time frame: 12 months]
- Quality of life scale [Time frame: 12 months]
Eligibility 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
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: NCT06292286 · UW 22-704