NCT03378128

Debulking Surgery in Ovarian Cancer

Minimally Invasive Interval Debulking Surgery in Ovarian Cancer

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Case Comprehensive Cancer Center · Academic / Other
• Sex: Female
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

The objective of this study is to implement, evaluate, and further investigate the role of minimally invasive surgery in patients undergoing interval debulking following neoadjuvant chemotherapy in patients with advanced ovarian cancer. Primary Objective: Prospectively evaluate the feasibility and safety of the minimally invasive interval debulking approach Secondary Objective(s) 1. Identify the patient population for which the minimally invasive interval debulking approach will offer comparable, if not improved, outcomes as the laparotomic interval debulking technique 2. Validate previously identified preoperative imaging computed tomography (CT) criteria and CA-125 values to predict optimal cytoreduction in laparotomic primary cytoreductive surgery and apply it towards the prediction of optimal cytoreduction (≤ 1 cm residual disease) following minimally invasive interval debulking surgery 3. Validate the previously identified laparoscopic scoring system for primary cytoreductive surgery and apply it towards the prediction of optimal cytoreduction (≤ 1 cm residual disease) following minimally invasive interval debulking surgery 4. Monitor the number of hospital days in the first 30 days postoperatively (length of stay after interval debulking including any days of readmission) 5. Evaluate the oncologic safety as it relates to time to return to chemotherapy in patients who undergo laparoscopic minimally invasive interval debulking surgery 6. Evaluate the complications as assessed by incidence of a composite of major complications and a second composite of minor complications Study Design This will be a prospective pilot study to address feasibility and safety to identify a patient population amenable to this surgical approach. This will allow for the future trial to include randomization

Conditions

• Malignant Neoplasm of Ovary
• Malignant Neoplasm of Fallopian Tube
• Malignant Neoplasm of Peritoneum

Interventions

Type	Name	Description
PROCEDURE	Diagnostic laparoscopy	The patient will initially undergo a diagnostic laparoscopy by a minimally invasive approach and entry method. The decision of which approach and entry to perform will be dictated by the primary surgeon of record's preference and their assessment of pre-operative patient factors. Once the primary surgeon determines the areas of macroscopic disease, he/she will make an assessment as to the need to convert to a laparotomy or continue laparoscopically. At the completion of the procedure, it will be noted whether an optimal cytoreduction (≤ 1 cm residual disease) or a sub-optimal cytoreduction (\>1 cm residual disease) was performed.

Timeline

• Start date: 2018-01-12
• Primary completion: 2020-04-30
• Completion: 2020-04-30
• First posted: 2017-12-19
• Last updated: 2022-03-14

Locations

2 sites across 1 country: United States