Secondary Cytoreductive Surgery in Platinum-resistant Recurrent Ovarian Cancers

Menoufia University

Status and phase: Withdrawn; Phase 3; Phase 2

Conditions: Recurrent Ovarian Carcinoma; Ovarian Cancer

Treatments: Drug: Chemotherapy; Procedure: secondary cytoreductive surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT04795596

388

Details and patient eligibility

About

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.

Full 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.

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

surgery + chemotherapy

Experimental group

Description:

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

Treatment:

Procedure: secondary cytoreductive surgery

Drug: Chemotherapy

chemotherapy alone

Active Comparator group

Description:

second line chemotherapy according to investigator's choice

Treatment:

Drug: Chemotherapy