Clinical trial NCT03378128: Debulking Surgery in Ovarian Cancer
Official title: Minimally Invasive Interval Debulking Surgery in Ovarian Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malignant Neoplasm of Ovary
Malignant Neoplasm of Fallopian Tube
Malignant Neoplasm of Peritoneum
Keywords: debulking surgery
Ovarian Cancer
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2017-12-19
Enrollment: 50
Sex: FEMALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of patients who undergo minimally-invasive interval debulking surgery (MI-IDS) among all patients enrolled in the study
timeFrame: 1 day
measure: Percentage of patients experiencing grade 3 or 4 post-operative complications
timeFrame: 30 days post-surgery
Secondary outcomes:
measure: Percentage of patients with optimal cytoreductive surgery (=< 1cm of disease seen at completion of surgery)
timeFrame: 1 day
measure: Proportion of patients who have a laparoscopy at the outset and remain laparoscopic throughout their surgery
timeFrame: 1 day
measure: Length of hospital stay
timeFrame: Up to 30 days after surgery
measure: Time to return to chemotherapy
timeFrame: 30 days after surgery
measure: Score of the Bristow preoperative predictive index parameters
timeFrame: 1 day
measure: Score of Suidan preoperative predictive index parameters
timeFrame: 1 day
Other outcomes:
Locations:
city: Charlotte
country: United States
facility: Atrium/Charlotte-Mecklenburg Hospital Authority
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic Taussig Cancer Center, Case Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Cleveland Clinic Taussig Cancer Center, Case Comprehensive Cancer Center
name: Chad Michener, MD
role: PRINCIPAL_INVESTIGATOR
References: