This novel study was specifically designed for platinum resistant recurrent ovarian cancers and aimed to compare cases who received secondary cytoreductive surgery for isolated recurrence and chemotherapy versus chemotherapy alone. This comparison will conduct the intraoperative events, postoperative morbidity and mortality, pathological outcomes and long-term oncological outcomes as regarding progression free survival and overall survival rates.
Baseline postoperative imaging with the use of abdominopelvic CT or MRI was to be completed during a 28-day window in which chemotherapy was initiated. Disease is also assessed after cycles 3 and 6 of trial treatment (and after cycle 8, if administered), every 3 months for 2 years, and then every 6 months thereafter. Physical examinations will be performed, and serum CA-125 levels measured at the beginning of each cycle of chemotherapy. Treatment-free interval (6 to 12 months or \>12 months after the last chemotherapy infusion) will be reported.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
resection of isolated recurrent ovarian carcinoma in platinum resistant disease
second line chemotherapy according to investigator's choice
Menoufia University, Faculty of medicine
Shibīn al Kawm, Menoufia, Egypt
progression free survival (PFS)
the time interval between the first relapse and the second relapse
Time frame: 6 months from enrollment
Overall survival (OS)
the time interval between the date of diagnosis till the date of death
Time frame: 18 months from enrollment
Adverse events (AE)
described according to the CTCAE
Time frame: 6 months from enrollment
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