About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Single group
Treatments tested in this trial
Carboplatin or cisplatin
Procedure/SurgeryCarboplatin of cisplatin for 3-6 cycles
Paclitaxel, gemcitabine or liposomal doxorubicin with or without bevacizumab or biosimilar
DrugPaclitaxel, gemcitabine or liposomal doxorubicin, for 3-6 cycles
Bevacizumab or biosimilar
DrugOptional
Cytoreductive surgery
Procedure/SurgeryCytoreductive surgery after chemotherapy
Treatment groups
Trial outcomes
Primary outcomes
Complete resection rate
Rate of complete resection at the time of operation
Secondary outcomes
12-month progression-free survival rate
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
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
Complications are graded by the Clavien-Dindo classification
Quality of life scale
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.
Sponsors and contacts
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