Debulking Surgery in Ovarian Cancer

Malignant Neoplasm of Fallopian Tube Clinical Trial

— MIID-SOC  

Official title:

Minimally Invasive Interval Debulking Surgery in Ovarian Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03378128
• Other study ID #: CASE9817
• Status: Completed
• Phase: N/A
• Start date: January 12, 2018
• Est. completion date: April 30, 2020

Study information

• Verified date: March 2022
• Source: Case Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: April 30, 2020
• Est. primary completion date: April 30, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Fallopian Tube Neoplasms
• Malignant Neoplasm of Fallopian Tube
• Malignant Neoplasm of Ovary
• Malignant Neoplasm of Peritoneum
• Neoplasms
• Ovarian Neoplasms
• Peritoneal Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United States	Atrium/Charlotte-Mecklenburg Hospital Authority	Charlotte	North Carolina
United States	Cleveland Clinic Taussig Cancer Center, Case Comprehensive Cancer Center	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Case Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients who undergo minimally-invasive interval debulking surgery (MI-IDS) among all patients enrolled in the study	Feasibility measure	1 day
Primary	Percentage of patients experiencing grade 3 or 4 post-operative complications	Accordion Severity Grading system with grade 3-4 scores. Grade 3 and 4 are severe complications or death. Severe complications are those requiring endoscopic or interventional radiologic procedures or re-operation as well as complications resulting in failure of 1 or more organ system. If fewer than 14% of patients have grade 3 or 4 complications, the surgery will be deemed safe.	30 days post-surgery
Secondary	Percentage of patients with optimal cytoreductive surgery (=< 1cm of disease seen at completion of surgery)	Rate of optimal resection after interval debulking surgery is expected to be between 73%-81%	1 day
Secondary	Proportion of patients who have a laparoscopy at the outset and remain laparoscopic throughout their surgery	If greater than 13 of the 50 patients planned to be enrolled on the study complete the laparoscopic surgery, the study will be deemed feasible	1 day
Secondary	Length of hospital stay	Time from the end of surgery to when the patient is discharged	Up to 30 days after surgery
Secondary	Time to return to chemotherapy	From the time of surgery to when the patient returns to chemotherapy treatments. Shorter times between surgery and chemotherapy are positive outcomes	30 days after surgery
Secondary	Score of the Bristow preoperative predictive index parameters	23 point index where higher scores indicate poorer outcomes	1 day
Secondary	Score of Suidan preoperative predictive index parameters	17 point index where higher scores indicate poorer outcomes	1 day