Debulking Surgery in Ovarian Cancer

NCT03378128 | Completed DMC

• 1 other identifier: CASE9817
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

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.

Conditions

Malignant Neoplasm of Ovary; Malignant Neoplasm of Fallopian Tube; Malignant Neoplasm of Peritoneum

Keywords

debulking surgery; Ovarian Cancer

Outcome Measures

Primary Outcomes (2)

• Proportion of patients who undergo minimally-invasive interval debulking surgery (MI-IDS) among all patients enrolled in the study

  Feasibility measure

  1 day

• 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 Outcomes (6)

• Percentage of patients with optimal cytoreductive surgery (=< 1cm of disease seen at completion of surgery)

  1 day

• Proportion of patients who have a laparoscopy at the outset and remain laparoscopic throughout their surgery

  1 day

• Length of hospital stay

  Up to 30 days after surgery

• Time to return to chemotherapy

  30 days after surgery

• Score of the Bristow preoperative predictive index parameters

  1 day

Study Arms (1)

diagnostic laparoscopic assessment after neoadjuvant chemo

EXPERIMENTAL

All patients will undergo a diagnostic laparoscopic assessment of disease following neoadjuvant chemotherapy

Procedure: Diagnostic laparoscopy

Interventions

Diagnostic laparoscopy PROCEDURE

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.

diagnostic laparoscopic assessment after neoadjuvant chemo

Eligibility Criteria

• Age: 19 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead

Study Sites (2)

Atrium/Charlotte-Mecklenburg Hospital Authority

Charlotte, North Carolina, 28203, United States

Location

Cleveland Clinic Taussig Cancer Center, Case Comprehensive Cancer Center

Cleveland, Ohio, 44195, United States

Location

Related Publications (1)

• Costales 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 DERIVED

MeSH Terms

Conditions

Ovarian Neoplasms; Fallopian Tube Neoplasms

Interventions

Laparoscopy

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Fallopian Tube Diseases

Intervention Hierarchy (Ancestors)

Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Chad Michener, MD

  Cleveland Clinic Taussig Cancer Center, Case Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2017
• First Posted: December 19, 2017
• Study Start: January 12, 2018
• Primary Completion: April 30, 2020
• Study Completion: April 30, 2020
• Last Updated: March 14, 2022

Record last verified: 2022-03

Locations

US (2)