NCT07031908Not yet recruiting
Minimally Invasive Interval Debulking Surgery in Advanced Ovarian Cancer
Minimally Invasive Interval Debulking Surgery in Advanced Ovarian Cancer, a Prospective Observational Study
Source: ClinicalTrials.gov · Last updated 22 Jun 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
In women with advanced epithelial ovarian cancer (AOC), neoadjuvant chemotherapy (NACT) combined with interval cytoreductive surgery and post-operative chemotherapy is an option. Several retrospective studies have demonstrated the feasibility of minimally invasive surgery in case of a good response to neoadjuvant chemotherapy, and prospective randomised trial is currently underway to demonstrate the non-inferiority of minimally invasive surgery compared to laparotomy in patients with an optimal response after 3-4 cycles of neoadjuvant chemotherapy (LANCE trial, NCT04575935). The aim of our study is to evaluate the feasibility of interval surgery after at least VI cycles of neoadjuvant chemotherapy with a minimally invasive approach.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 40 (estimated)
- First submitted
- 4 Jun 2025
- Start date
- 15 Jun 2025
- Primary completion date
- 15 Jun 2027
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Diseases
- Ovarian cancer
- NCT number
- NCT07031908
What you commit to
- Study type: Observational
- Planned participants: 40
- From 15 Jun 2025 to the primary completion date, 15 Jun 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
Other
- Inability to tolerate prolonged Trendelenburg position or pneumoperitoneum
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS, UOC Ginecologia Oncologica Coordinator of this site? Confirm its status | Roma | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.