Purpose of this Study
We are doing this study to compare 2 different surgeries for epithelial ovarian cancer. We want to know if an investigational surgical procedure called minimally invasive surgery can offer better results than the standard surgery, which is called laparotomy. We hope to find out if one procedure or the other is preferable when it comes to preventing cancer from returning and giving patients a better quality of life after their surgery.
Who Can Participate?
Eligibility
Adults ages 18+ who:<ul>
<li>Are diagnosed with stage IIIC or IV invasive epithelial ovarian carcinoma, primary peritoneal carcinoma, or fallopian-tube carcinoma, or have pathology that is consistent with high-grade mullerian carcinoma</li>
<li>Have completed 3 or 4 cycles of platinum-based chemotherapy or an investigational neoadjuvant regimen</li>
<li>Are considered by their treating physician to be a suitable candidate for surgery</li></ul>
For more information about this study, please contact the study team at <a href= "mailto: sarah.linhart@duke.edu">sarah.linhart@duke.edu.</a>
<li>Are diagnosed with stage IIIC or IV invasive epithelial ovarian carcinoma, primary peritoneal carcinoma, or fallopian-tube carcinoma, or have pathology that is consistent with high-grade mullerian carcinoma</li>
<li>Have completed 3 or 4 cycles of platinum-based chemotherapy or an investigational neoadjuvant regimen</li>
<li>Are considered by their treating physician to be a suitable candidate for surgery</li></ul>
For more information about this study, please contact the study team at <a href= "mailto: sarah.linhart@duke.edu">sarah.linhart@duke.edu.</a>
Age Range
18-110
Sex/Genders
Female (cisgender)
Looking for Healthy Participants
Yes
What is Involved?
If you choose to join this study, you will get a random assignment (like a coin flip) to one of 2 groups:<ul>
<li><strong>Group A:</strong> If you are in this group, you will have minimally invasive surgery.</li>
<li><strong>Group B:</strong> If you are in this group, you will have a laparotomy.</li></ul>
Your participation in this study is expected to last 5 years. We will follow you through your pre-surgery chemo, surgery, and after surgery chemo. You will also fill out some questionnaires at the beginning of the study.
<li><strong>Group A:</strong> If you are in this group, you will have minimally invasive surgery.</li>
<li><strong>Group B:</strong> If you are in this group, you will have a laparotomy.</li></ul>
Your participation in this study is expected to last 5 years. We will follow you through your pre-surgery chemo, surgery, and after surgery chemo. You will also fill out some questionnaires at the beginning of the study.
Locations
Duke University Hospital
Duke Raleigh Hospital
Visit Timing
Weekdays
Compensation
No
Spanish Materials Available
No
Study Details
Full Title
Laparoscopic cytoreduction After Neoadjuvant ChEmotherapy (LANCE)
Principal Investigator
Jennifer
McNally
Protocol Number
PRO00106514
NCT ID
NCT04575935
Phase
III
Enrollment Status
Open to Enrollment