Secondary Cytoreductive Surgery in Platinum-resistant Recurrent Ovarian Cancers

Sponsor

Menoufia University (Other)

Overall Status

Withdrawn

CT.gov ID

NCT04795596

Collaborator

(none)

Enrollment

Location

Arms

12.3

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Ovarian Cancer Recurrent Ovarian Carcinoma	Procedure: secondary cytoreductive surgery Drug: Chemotherapy	Phase 2/Phase 3

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 Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

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 chemotherapypatients with platinum resistant cancer ovary will be randomized to one of two arms; either chemotherapy alone or surgical resection followed by chemotherapy

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Apr 1, 2021

Actual Primary Completion Date :

Apr 9, 2022

Actual Study Completion Date :

Apr 9, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: surgery + chemotherapy surgical resection for recurrent platinum resistant ovarian cancer followed by second line chemotherapy as per the investigator's choice	Procedure: secondary cytoreductive surgery resection of isolated recurrent ovarian carcinoma in platinum resistant disease Other Names: re-resection Drug: Chemotherapy second line chemotherapy according to investigator's choice
Active Comparator: chemotherapy alone second line chemotherapy according to investigator's choice	Drug: Chemotherapy second line chemotherapy according to investigator's choice

Arm

Intervention/Treatment

Experimental: surgery + chemotherapy

surgical resection for recurrent platinum resistant ovarian cancer followed by second line chemotherapy as per the investigator's choice

Procedure: secondary cytoreductive surgery

resection of isolated recurrent ovarian carcinoma in platinum resistant disease

Other Names:

re-resection

Drug: Chemotherapy

second line chemotherapy according to investigator's choice

Active Comparator: chemotherapy alone

second line chemotherapy according to investigator's choice

Drug: Chemotherapy

second line chemotherapy according to investigator's choice

Outcome Measures

Primary Outcome Measures

progression free survival (PFS) [6 months from enrollment]
the time interval between the first relapse and the second relapse

Secondary Outcome Measures

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