Debulking Surgery in Ovarian Cancer
| Status: | Recruiting |
|---|---|
| Conditions: | Ovarian Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 19 - Any |
| Updated: | 5/9/2018 |
| Start Date: | January 12, 2018 |
| End Date: | April 2019 |
| Contact: | Anthony Costales, MD |
| Email: | CancerCenterResearch@ccf.org |
| Phone: | 866-223-8100 |
Minimally Invasive Interval Debulking Surgery in Ovarian Cancer
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.
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.
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 patients with advanced ovarian cancer.
Primary Objective:
Prospectively evaluate the feasibility and safety of the minimally invasive interval
debulking approach
Secondary Objective(s)
1. Identify the patient population for which the minimally invasive interval debulking
approach will offer comparable, if not improved, outcomes as the laparotomic interval
debulking technique
2. Validate previously identified preoperative imaging computed tomography (CT) criteria
and CA-125 values to predict optimal cytoreduction in laparotomic primary cytoreductive
surgery and apply it towards the prediction of optimal cytoreduction (≤ 1 cm residual
disease) following minimally invasive interval debulking surgery
3. Validate the previously identified laparoscopic scoring system for primary cytoreductive
surgery and apply it towards the prediction of optimal cytoreduction (≤ 1 cm residual
disease) following minimally invasive interval debulking surgery
4. Monitor the number of hospital days in the first 30 days postoperatively (length of stay
after interval debulking including any days of readmission)
5. Evaluate the oncologic safety as it relates to time to return to chemotherapy in
patients who undergo laparoscopic minimally invasive interval debulking surgery
6. Evaluate the complications as assessed by incidence of a composite of major
complications and a second composite of minor complications
Study Design This will be a prospective pilot study to address feasibility and safety to
identify a patient population amenable to this surgical approach. This will allow for the
future trial to include randomization
minimally invasive surgery in patients undergoing interval debulking following neoadjuvant
chemotherapy in patients with advanced ovarian cancer.
Primary Objective:
Prospectively evaluate the feasibility and safety of the minimally invasive interval
debulking approach
Secondary Objective(s)
1. Identify the patient population for which the minimally invasive interval debulking
approach will offer comparable, if not improved, outcomes as the laparotomic interval
debulking technique
2. Validate previously identified preoperative imaging computed tomography (CT) criteria
and CA-125 values to predict optimal cytoreduction in laparotomic primary cytoreductive
surgery and apply it towards the prediction of optimal cytoreduction (≤ 1 cm residual
disease) following minimally invasive interval debulking surgery
3. Validate the previously identified laparoscopic scoring system for primary cytoreductive
surgery and apply it towards the prediction of optimal cytoreduction (≤ 1 cm residual
disease) following minimally invasive interval debulking surgery
4. Monitor the number of hospital days in the first 30 days postoperatively (length of stay
after interval debulking including any days of readmission)
5. Evaluate the oncologic safety as it relates to time to return to chemotherapy in
patients who undergo laparoscopic minimally invasive interval debulking surgery
6. Evaluate the complications as assessed by incidence of a composite of major
complications and a second composite of minor complications
Study Design This will be a prospective pilot study to address feasibility and safety to
identify a patient population amenable to this surgical approach. This will allow for the
future trial to include randomization
Inclusion Criteria:
- 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 Criteria:
- 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
We found this trial at
1
site
Cleveland, Ohio 44195
Principal Investigator: Anthony Costales, MD
Phone: 866-223-8100
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