Debulking Surgery in Ovarian Cancer

The purpose of this study is to see if patients undergoing a laparoscopic surgery for removal of ovarian, fallopian tube, or primary peritoneal cancer following neoadjuvant chemotherapy (neoadjuvant- chemotherapy given before surgery) is feasible, safe, and provides similar outcomes as compared to undergoing a large abdominal incision. Minimally invasive, or laparoscopic, surgery is a type of surgery where only small incisions are made on the abdomen and surgical instruments are placed through these incisions to perform the surgery. This type of surgery has been shown to improve outcomes in many types of surgery, including in gynecologic cancer surgery. Specifically, researchers know that patients who have minimally invasive surgery have less pain after surgery, can go home quicker from the hospital, healing time is more rapid, and potentially this can translate into returning to chemotherapy sooner. Specifically, in ovarian, fallopian tube, and primary peritoneal cancer, minimally invasive surgery has not been used as much because these cancers can have tumors all throughout the inside of the abdomen (i.e. wide tumor burden) and located in areas that are sometimes not easily reachable with laparoscopic instruments. However, the reason patients receive neoadjuvant chemotherapy is to shrink the tumor/s to make the surgery less extensive and the recovery easier. It is unknown if minimally invasive surgery can be used in this setting and by studying this, the study team will be able to determine if patient outcomes are improved by implementing (using) this surgical technique.

Sex

Female

Minimum age

19 Years

Inclusion Criteria:

* Subjects must have histologically or cytologically confirmed advanced epithelial ovarian, fallopian tube, or primary peritoneal (≥ International Federation of Gynecology and Obstetrics (FIGO) Stage IIIC)
* Subjects must have received neoadjuvant chemotherapy (any number of cycles) with complete or partial response as assessed by Response Evaluation Criteria in Solid Tumors 1.1 (RECIST) or CA 125 response by Gynecologic Cancer Intergroup (GCIG) criteria
* Performance status Eastern Cooperative Oncology Group (ECOG) performance status 0-2
* Subjects must have the ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

* Severe cardiopulmonary disease precluding the use of the minimally invasive technique as deemed by Internal Medicine Preoperative Assessment, Consultant and Treatment (IMPACT)
* Inability to tolerate prolonged Trendelenburg position as deemed by anesthesiology
* Severe hip disease precluding the use of dorsolithotomy position
* Prior pelvic or abdominal radiation
* Clinically large pelvic masses reaching above the umbilicus
* Absence of a documented PR or CR according to RECIST 1.1 or CA 125 response by GCIG criteria to neoadjuvant chemotherapy
* Presence of parenchymal liver metastases on imaging
* Absence of baseline imaging studies (CT abdomen/pelvis and Chest x-ray minimum) both prior to beginning chemotherapy and following chemotherapy

• DERIVEDCostales AB, Crane EK, Chambers L, Yao M, Chau D, Naumann WR, Debernardo R, Ricci S, Rose PG, Michener CM. Laparoscopic predictability of minimally invasive interval debulking in advanced ovarian cancer: The MIID-SOC trial. Gynecol Oncol. 2024 Jun;185:143-147. doi: 10.1016/j.ygyno.2024.02.019. Epub 2024 Feb 27. PMID 38417209