Minimally Invasive Surgery After Neoadjuvant Chemotherapy for the Treatment of Stage IIIC-IV Ovarian, Primary Peritoneal, or Fallopian Tube Cancer, LANCE Trial
Chemotherapy: Receive standard of care chemotherapy
Laparotomy: Undergo laparotomy
Minimally Invasive Surgery: Undergo MIS
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
Study 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.
Eligibility
Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
Disease free survival (DFS) — Between randomization and physical or radiographic evidence of recurrence (local/distant) or death (all causes), assessed up to 5 years Kaplan Meier curves will be used to describe DFS over time. Log-rank test will be used to compare DFS between the control and experimental arms. The treatment effects will be summarized by means of a hazard ratio with its associated 95% confidence interval. Two years DFS rate will be computed with a targeted 95% confidence interval (CI).
Trial sites (19)
Facility
City
Region
Status
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami
Florida
Recruiting
Cleveland Clinic Foundation - Florida
Weston
Florida
Recruiting
Massachusetts General Hospital
Boston
Massachusetts
Recruiting
Dana Farber Cancer Institute
Boston
Massachusetts
Recruiting
NYU Langone Health
Mineola
New York
Recruiting
Columbia University Medical Center
New York
New York
Recruiting
Duke
Durham
North Carolina
Recruiting
Cleveland Clinic
Cleveland
Ohio
Recruiting
St. Luke's University Health Network
Bethlehem
Pennsylvania
Recruiting
Lyndon Baines Johnson General
Houston
Texas
Recruiting
Houston Methodist
Houston
Texas
Recruiting
M D Anderson Cancer Center
Houston
Texas
Recruiting
University of Wisconsin Carbone Cancer Center
Madison
Wisconsin
Active Not Recruiting
Arthur J.E. Child Comprehensive Cancer Centre - Calgary
Calgary
Canada
Recruiting
University Health Network - Princess Margaret Cancer Centre
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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