Principal Investigator
Enrollment Status
Clinical Trial ID
Clinical Trial Summary
This phase III trial compares minimally invasive surgery (MIS) to laparotomy in treating
patients with stage IIIC-IV ovarian, primary peritoneal, or fallopian tube cancer who are
receiving chemotherapy before and after surgery (neoadjuvant chemotherapy). MIS is a surgical
procedure that uses small incision(s) and is intended to produce minimal blood loss and pain
for the patient. Laparotomy is a surgical procedure which allows the doctors to remove some
or all of the tumor and check if the disease has spread to other organs in the body. MIS may
work the same or better than standard laparotomy after chemotherapy in prolonging the return
of the disease and/or improving quality of life after surgery.
Phase
Phase 3
Funding Agency/Sponsor
Externally Peer-Reviewed
Disease
Gynecologic Cancer
Enrollment Eligibility
Inclusion Criteria:
- Stage IIIC or IV, high-grade (serous, endometrioid, clear-cell, transitional
carcinomas), invasive epithelial ovarian carcinoma, primary peritoneal carcinoma, or
fallopian-tube carcinoma or pathology consistent with high-grade Mullerian carcinoma
- Complete or partial response to 3 or 4 cycles of NACT (clinical response will be
assessed by clinical radiologist at each site, with Response Evaluation Criteria in
Solid Tumors [RECIST] 1.1 guidance provided)
- Patients that received only 3 cycles of NACT must have completed their regimen within
9 weeks. Patients that received 4 cycles of NACT must have completed their regimen
within 12 weeks
- Normalization of CA-125 according to individual participating center reference range
(Note: Among patients with a normal CA-125 at initiation of therapy, the CA-125 cannot
exceed 35 U/mL at the completion of 3 or 4 cycles if NACT prior to interval debulking
surgery)
- Time frame of < 6 weeks from the last cycle of NACT to interval debulking surgery
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Signed informed consent and ability to comply with follow-up
- Negative pregnancy test by blood or urine (within 14 days prior to surgery)
Exclusion Criteria:
- Evidence of tumor not amenable to minimally invasive resection on pre-operative
imaging (computed tomography [CT], positron emission tomography [PET]-CT, or magnetic
resonance imaging [MRI]) including but not limited to the following findings
- Failure of improvement of ascites during NACT (trace ascites is allowed)
- Small bowel or gastric tumor involvement
- Colon or rectal tumor involvement
- Diaphragmatic tumor involvement
- Splenic or hepatic surface or parenchymal tumor involvement
- Mesenteric tumor involvement
- Tumor infiltration of the lesser peritoneal sac
- History of other malignancies in the previous five years, except basal cell carcinoma
of the skin
- History of psychological, familial, sociological or geographical condition potentially
preventing compliance with the study protocol and follow-up schedule
- Inability to tolerate prolonged Trendelenburg position or pneumoperitoneum as deemed
by participating institution's clinicians
- Any other contraindication to MIS as assessed by the clinician