Minimally Invasive Interval Debulking Surgery in Advanced Ovarian Cancer

Launched by FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS · Jun 19, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a less invasive type of surgery for women with advanced ovarian cancer who have already received chemotherapy. Usually, women with this condition have chemotherapy first to shrink the tumor, followed by surgery to remove as much of the cancer as possible, and then more chemotherapy. This study is looking at whether the surgery can be done using small cuts and special instruments (called minimally invasive surgery), instead of the traditional large abdominal surgery, after women have had at least six cycles of chemotherapy.

Women who might be eligible for this trial are those with advanced ovarian cancer or similar types of cancer in the pelvic area, who have responded well to chemotherapy, shown by imaging tests and blood markers. They need to be in good overall health and able to follow the study procedures. Before surgery, doctors will carefully review scans to make sure the cancer can be safely removed using the less invasive approach. If surgery using small cuts is possible, participants will have this procedure; if not, they will not be included in the study. The goal is to see if this less invasive surgery is a safe and effective option, which could mean a quicker recovery and fewer complications for patients.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Stage IIIC or IV high-grade invasive epithelial ovarian carcinoma (serous, endometrioid, clear cell, transitional), primary peritoneal carcinoma, or fallopian tube carcinoma, or pathology consistent with high-grade Müllerian carcinoma.
• • Partial or complete radiological response of abdominal cavity disease after at least 6 cycles of neoadjuvant chemotherapy (NACT).
• • CA125 \< 100 U/mL.
• • ECOG performance status 0-1.
• • Signed informed consent and ability to comply with follow-up, including in cases where the patient has a legal guardian. In such cases, consent will be provided by the legal guardian.
• • Review of imaging by a radiologist and senior surgeon at a multidisciplinary tumor board, particularly evaluating hepatic hilum involvement, mesenteric root, extensive peritoneal disease in the upper abdomen, extensive hepatic or gastric involvement, and extensive intestinal involvement.
• • If all the previous criteria are met and protocol acceptance is obtained, the patient will undergo a laparoscopic evaluation of all abdominal quadrants to confirm the feasibility of minimally invasive surgery (MIS). Surgery will be considered feasible if complete gross resection can be achieved with minimally invasive surgery. If minimally invasive surgery is not feasible, the patient will be excluded from the study, and the reason for unfeasibility will be described.
• Exclusion Criteria:
• • Evidence of a tumor not amenable to minimally invasive complete resection on preoperative imaging (CT, PET-CT, or MRI). Radiologic criteria (tumor board evaluation): hepatic hilum involvement, mesentery root, extensive peritoneal disease in upper abdomen, extensive hepatic or gastric involvement, extensive intestinal involvement
• • Disease free of other active malignancies within the past 5 years, except basal cell carcinoma of the skin.
• • History of psychological, familial, sociological, or geographic conditions potentially impeding adherence to the study protocol and follow-up program
• • Inability to tolerate prolonged Trendelenburg position or pneumoperitoneum