Minimally Invasive Surgery for Advanced Ovarian Cancer: A Pilot Randomized Trial
Abstract
Objective: The proposed project is designed to determine whether some patients with late-stage ovarian cancer can safely have an operation to remove the cancer (called a cytoreductive surgery) using minimally invasive surgery instead of a traditional operation done through a large incision on the abdomen. Background: Surgeons perform minimally invasive surgery using very small incisions and inserting a slender camera, called a laparoscope, and surgical instruments into the abdomen. Sometimes surgeons use a surgical robot to control the camera and the instruments and other times they use their hands. Minimally invasive leads to faster recovery, less pain, and is less likely to cause an infection than traditional surgery, but it is not always safe for a cancer operation. For cancers of women’s reproductive organs, there have been conflicting results about the safety of minimally invasive surgery. Randomized trials, the best kind of studies we can do, have found that minimally invasive surgery is safe in endometrial cancer, but not in cervical cancer. There have been no randomized trials yet to evaluate the safety of minimally invasive surgery in ovarian cancer patients. Traditionally, surgery for advanced ovarian cancer has been done before chemotherapy is given. When surgery is performed first, there is usually too much cancer in the abdomen and pelvis for a surgeon to use minimally invasive surgery in late-stage ovarian cancer patients. However, recent studies have shown that giving women with late-stage ovarian cancer chemotherapy before surgery can shrink the cancer and make surgery easier. This approach, called neoadjuvant chemotherapy, has become more and more common in the United States in recent years. When ovarian cancer shrinks from neoadjuvant chemotherapy, it sometimes becomes possible to use minimally invasive surgery to remove the cancer that remains. There have been several studies showing that it is possible to perform minimally invasive cytoreductive surgery for ovarian cancer, and this approach to treatment is gaining popularity; one in four women who had neoadjuvant chemotherapy had a minimally invasive cancer surgery in 2017. However, the studies that have been done to date are not conclusive. It is still unknown which patients could have a successful minimally invasive ovarian cancer surgery. Even more importantly, it has not yet known whether minimally invasive surgery is as effective as open surgery in terms helping patients live longer without cancer. Aim 1. To complete an observational study that will investigate whether it is possible to predict which women who received neoadjuvant chemotherapy for late-stage ovarian cancer will be able to have all the remaining cancer removed by minimally invasive surgery. Why It Matters: If we can help patients and doctor know in advanced of surgery whether minimally invasive surgery is likely to work, patients and surgeons could make more informed decisions about their surgical plan. Aims 2: To perform a small, randomized study (called a pilot study) in which women who have had a good response to chemotherapy administered before surgery for late-stage ovarian cancer are randomly assigned to minimally invasive surgery or surgery through a large incision. Why It Matters: Performing this pilot study is the first step to completing the large, randomized trial that can determine whether minimally invasive surgery provides equivalent cancer control (time that patients remain alive and without cancer) as open surgery. In fact, this pilot trial will serve as the first part of that larger study. Aim 3: To evaluate whether patients who are randomized to minimally invasive surgery in our pilot study report having a higher quality of life than those randomized to surgery through a big incision. Why It Matters: While we know the benefits of minimally invasive surgery in general, we do not know how these benefits are experienced by w
Document Details
- Document Type
- DoD Grant Award
- Publication Date
- Dec 28, 2022
- Source ID
- W81XWH2211060
Entities
People
- Alexander Melamed
Organizations
- Massachusetts General Hospital
- United States Army