Ovarian Cancer, Recurrent Ovarian Carcinoma
Conditions
Keywords
ovarian cancer, platinum resistant, cytoreductive surgery, recurrent ovarian cancer, complete resection
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREsecondary cytoreductive surgery
resection of isolated recurrent ovarian carcinoma in platinum resistant disease
DRUGChemotherapy
second line chemotherapy according to investigator's choice
Sponsors
Menoufia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
patients with platinum resistant cancer ovary will be randomized to one of two arms; either chemotherapy alone or surgical resection followed by chemotherapy
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* platinum-resistant, recurrent epithelial ovarian cancer * amenable to complete gross resection, isolated recurrence * adequate renal, hepatic, and bone marrow function, * performance-status ECOG score of 0 to 2.
Exclusion criteria
* not medically fit for surgery * diffuse carcinomatosis, ascites, or extra-abdominal disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| progression free survival (PFS) | 6 months from enrollment | the time interval between the first relapse and the second relapse |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival (OS) | 18 months from enrollment | the time interval between the date of diagnosis till the date of death |
| Adverse events (AE) | 6 months from enrollment | described according to the CTCAE |
Countries
Egypt
Outcome results
None listed