NCT04795596

Secondary Cytoreductive Surgery in Platinum-resistant Recurrent Ovarian Cancers

Clinical Outcomes of Secondary Cytoreductive Surgery in Platinum-resistant Ovarian Cancers With Isolated Recurrence

• Status: Withdrawn
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Menoufia University · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Ovarian Cancer
• Recurrent Ovarian Carcinoma

Interventions

Type	Name	Description
PROCEDURE	secondary cytoreductive surgery	resection of isolated recurrent ovarian carcinoma in platinum resistant disease
DRUG	Chemotherapy	second line chemotherapy according to investigator's choice

Timeline

• Start date: 2021-04-01
• Primary completion: 2022-04-09
• Completion: 2022-04-09
• First posted: 2021-03-12
• Last updated: 2022-04-15

Locations

1 site across 1 country: Egypt