Minimally Invasive Surgery After Neoadjuvant Chemotherapy for the Treatment of Stage IIIC-IV Ovarian, Primary Peritoneal, or Fallopian Tube Cancer, LANCE Trial
Advanced Ovarian Carcinoma, Fallopian Tube Clear Cell Adenocarcinoma, Fallopian Tube Endometrioid Tumor
About this trial
This is an interventional treatment trial for Advanced Ovarian Carcinoma
Eligibility Criteria
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
Sites / Locations
- University of Miami Miller School of Medicine-Sylvester Cancer CenterRecruiting
- NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer CenterRecruiting
- DukeRecruiting
- Lyndon Baines Johnson GeneralRecruiting
- M D Anderson Cancer CenterRecruiting
- University of Wisconsin Carbone Cancer CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Arm A (MIS, standard of care chemotherapy)
Arm B (laparotomy, standard of care chemotherapy)
Patients undergo MIS within 6 weeks after last cycle of standard of care neoadjuvant chemotherapy. If during MIS the surgeon thinks complete gross resection can only be accomplished by performing an open procedure, patients may undergo laparotomy instead. Within 6 weeks after surgery, patients receive standard of care chemotherapy.
Patients undergo laparotomy within 6 weeks after last cycle of standard of care neoadjuvant chemotherapy. Within 6 weeks after surgery, patients receive standard of care chemotherapy.