Status:
COMPLETED
Debulking Surgery in Ovarian Cancer
Lead Sponsor:
Case Comprehensive Cancer Center
Conditions:
Malignant Neoplasm of Ovary
Malignant Neoplasm of Fallopian Tube
Eligibility:
FEMALE
19+ years
Phase:
NA
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- ...
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 pa...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 12 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 30 2020
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT03378128
Start Date
January 12 2018
End Date
April 30 2020
Last Update
March 14 2022
Active Locations (2)
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1
Atrium/Charlotte-Mecklenburg Hospital Authority
Charlotte, North Carolina, United States, 28203
2
Cleveland Clinic Taussig Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44195