M.D. Anderson Cancer Center
Dr. Liat Hogen
Inclusion Criteria:
- Age ≥ 18 years old
- 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.
- Patient is considered by treating physician to be a surgical candidate after
completion of 3 to 4 cycles of platinum-based chemotherapy, or an investigational
neoadjuvant regimen given according to protocol, with complete radiologic resolution
of any disease outside the abdominal cavity. Pleural effusions are acceptable per
the local PI's discretion.
- 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 NACT prior to interval debulking
surgery.) or has a CA-125 value ≤500 and is scheduled to undergo a diagnostic
laparoscopy prior to debulking surgery. a. For patients undergoing diagnostic
laparoscopy, surgeon considers that optimal debulking is feasible either by MIS or
laparotomy.
- Timeframe of < 6 weeks (42 days) from the last cycle of NACT to interval debulking
surgery. Overall timeframe may be extended per MD Anderson PI discretion.
- 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)
- Disease free of other active malignancies in the previous five years, except basal
and squamous cell carcinomas of the skin
Exclusion Criteria:
- Evidence of tumor not amenable to minimally invasive resection on pre-operative
imaging (CT, PET-CT, or MRI) including but not limited to the following findings
that may preclude minimally invasive resection per surgeon's assessment. • 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 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