Phase
Condition
Peritoneal Cancer
Ovarian Cysts
Digestive System Neoplasms
Treatment
Questionnaire Administration
Laparotomy
Chemotherapy
Clinical Study ID
Ages > 18 Female
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Age ≥ 18 years old
Stage IIIC or IV, high-grade (serous, endometrioid, clear-cell, transitionalcarcinomas), invasive epithelial ovarian carcinoma, primary peritoneal carcinoma, orfallopian-tube carcinoma or pathology consistent with high-grade mulleriancarcinoma.
Patient is considered by treating physician to be a surgical candidate aftercompletion of 3 to 4 cycles of platinum-based chemotherapy, or an investigationalneoadjuvant regimen given according to protocol, with complete radiologic resolutionof any disease outside the abdominal cavity. Pleural effusions are acceptable perthe 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-125cannot exceed 35 U/mL at the completion of NACT prior to interval debulkingsurgery.) or has a CA-125 value ≤500 and is scheduled to undergo a diagnosticlaparoscopy prior to debulking surgery. a. For patients undergoing diagnosticlaparoscopy, surgeon considers that optimal debulking is feasible either by MIS orlaparotomy.
Timeframe of < 6 weeks (42 days) from the last cycle of NACT to interval debulkingsurgery. 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 basaland squamous cell carcinomas of the skin
Exclusion
Exclusion Criteria:
Evidence of tumor not amenable to minimally invasive resection on pre-operativeimaging (CT, PET-CT, or MRI) including but not limited to the following findingsthat may preclude minimally invasive resection per surgeon's assessment. • Failureof improvement of ascites during NACT (trace ascites is allowed) • Small bowel orgastric tumor involvement • Colon or rectal tumor involvement • Diaphragmatic tumorinvolvement • 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 conditionpotentially preventing compliance with the study protocol and follow-up schedule
Inability to tolerate prolonged Trendelenburg position or pneumoperitoneum as deemedby participating institution's clinicians
Any other contraindication to MIS as assessed by the clinician
Study Design
Study Description
Connect with a study center
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida 33136
United StatesActive - Recruiting
Dana Farber Cancer Institute
Boston, Massachusetts 02215
United StatesActive - Recruiting
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
New York, New York 10032
United StatesActive - Recruiting
Duke
Durham, North Carolina 27710
United StatesActive - Recruiting
Lyndon Baines Johnson General
Houston, Texas 77026
United StatesActive - Recruiting
M D Anderson Cancer Center
Houston, Texas 77030
United StatesActive - Recruiting
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin 53792
United StatesActive - Recruiting
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