Secondary Cytoreductive Surgery in Platinum-resistant Recurrent Ovarian Cancers

Phase 2

Withdrawn

• Conditions: Ovarian Cancer; Recurrent Ovarian Carcinoma
• Interventions: Procedure: secondary cytoreductive surgery; Drug: Chemotherapy

• Registration Number: NCT04795596
• Lead Sponsor: Menoufia University

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.

Study Timeline

• Study First Submitted: 2021-03-09
• Study First Submitted QC: 2021-03-09
• Study First Posted: 2021-03-12
• Study Start: 2021-04-01
• Status Verified: 2022-04
• Primary Completion: 2022-04-09
• Study Completion: 2022-04-09
• Last Update Submitted: 2022-04-09
• Last Update Posted: 2022-04-15

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
surgery + chemotherapy	secondary cytoreductive surgery	surgical resection for recurrent platinum resistant ovarian cancer followed by second line chemotherapy as per the investigator's choice
surgery + chemotherapy	Chemotherapy	surgical resection for recurrent platinum resistant ovarian cancer followed by second line chemotherapy as per the investigator's choice
chemotherapy alone	Chemotherapy	second line chemotherapy according to investigator's choice

Primary Outcome Measures

Name	Time	Method
progression free survival (PFS)	6 months from enrollment	the time interval between the first relapse and the second relapse

Secondary Outcome Measures

Name	Time	Method
Adverse events (AE)	6 months from enrollment	described according to the CTCAE
Overall survival (OS)	18 months from enrollment	the time interval between the date of diagnosis till the date of death

Trial Locations

Locations (1)

Menoufia University, Faculty of medicine; 🇪🇬 Shibīn Al Kawm, Menoufia, Egypt