This trial looks at two types of surgery for women with advanced ovarian cancer. One method is minimally invasive surgery (MIS), which uses small cuts and aims to reduce pain and recovery time. The other method is laparotomy, a more traditional surgery that involves larger cuts. The goal is to see if MIS is just as good as laparotomy in helping patients stay healthy and live well after surgery.
The trial's ID number is NCT04575935. This is a Phase 3 trial, which means it is looking at how well the treatments work and how safe they are. The trial is FDA-regulated and aims to include about 580 participants.
Who can join
Women aged 18 and older can join if they have stage IIIC or IV ovarian, fallopian tube, or primary peritoneal cancer. They should have completed 3 to 4 cycles of chemotherapy and be considered surgical candidates. The trial team will check all eligibility requirements before anyone joins.
Conditions
Advanced Ovarian Carcinoma, Fallopian Tube Clear Cell Adenocarcinoma, Fallopian Tube Endometrioid Tumor, Fallopian Tube Serous Neoplasm, Fallopian Tube Transitional Cell Carcinoma, Ovarian Clear Cell Adenocarcinoma, Ovarian Endometrioid Adenocarcinoma, Ovarian Serous Adenocarcinoma, Ovarian Transitional Cell Carcinoma, Primary Peritoneal Clear Cell Adenocarcinoma, Primary Peritoneal Endometrioid Adenocarcinoma, Primary Peritoneal Serous Adenocarcinoma, Primary Peritoneal Transitional Cell Carcinoma, Stage IIIC Fallopian Tube Cancer AJCC v8, Stage IIIC Ovarian Cancer AJCC v8, Stage IIIC Primary Peritoneal Cancer AJCC v8, Stage IV Fallopian Tube Cancer AJCC v8, Stage IV Ovarian Cancer AJCC v8, Stage IV Primary Peritoneal Cancer AJCC v8, Stage IVA Fallopian Tube Cancer AJCC v8, Stage IVA Ovarian Cancer AJCC v8, Stage IVA Primary Peritoneal Cancer AJCC v8, Stage IVB Fallopian Tube Cancer AJCC v8, Stage IVB Ovarian Cancer AJCC v8, Stage IVB Primary Peritoneal Cancer AJCC v8
Age group
Adult, Older adult
Sex
Female
The study team makes the final call on eligibility.
What happens in the study
Participants will be randomly placed in one of two groups. In Arm A, they will have minimally invasive surgery followed by standard chemotherapy. In Arm B, they will have laparotomy followed by the same chemotherapy. Everyone in the trial will receive chemotherapy after their surgery.
Where
This trial is running at 13 locations in the United States. 12 of them are currently recruiting.
Cleveland Clinic
Cleveland, Ohio
Recruiting
Cleveland Clinic Foundation - Florida
Weston, Florida
Recruiting
Columbia University Medical Center
New York, New York
Recruiting
Dana Farber Cancer Institute
Boston, Massachusetts
Recruiting
Duke
Durham, North Carolina
Recruiting
Houston Methodist
Houston, Texas
Recruiting
Lyndon Baines Johnson General
Houston, Texas
Recruiting
M D Anderson Cancer Center
Houston, Texas
Recruiting
The first 8 of 13 sites are listed here. The registry record has the full list.