Recurrent Ovarian Carcinoma
Conditions
Brief summary
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
PROCEDURECarboplatin or cisplatin
Carboplatin of cisplatin for 3-6 cycles
DRUGPaclitaxel, gemcitabine or liposomal doxorubicin with or without bevacizumab or biosimilar
Paclitaxel, gemcitabine or liposomal doxorubicin, for 3-6 cycles
DRUGBevacizumab or biosimilar
Optional
PROCEDURECytoreductive surgery
Cytoreductive surgery after chemotherapy
Sponsors
The University of Hong Kong
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Neoadjuvant carboplatin and paclitaxel followed by cytoreductive surgery
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete resection rate | 12 months | Rate of complete resection at the time of operation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 12-month progression-free survival rate | 12 months | The time from the first dose of chemotherapy to the first documentation of objective tumor progression (PD) or to death due to any cause, whichever occurs first. |
| 12-month overall survival rate | 12 months | Overall survival is defined as the time from the first dose of chemotherapy to the date of death due to any cause. |
| Surgical complication rate | 12 months | Complications are graded by the Clavien-Dindo classification |
| Quality of life scale | 12 months | Different functional scales will be assessed by questionnaires like the EORTC questionnaires where all scales range from 0-100. The higher the score, the greater the intensity of that particular item is. |
Countries
Hong Kong
Contacts
Primary ContactLesley Lau
Outcome results
None listed