Laparoscopic Cytoreduction After Neoadjuvant Chemotherapy in High-Grade Epithelial Ovarian Cancer: A LANCE Randomized Clinical Trial.
J Alejandro Rauh-Hain, Alexander Melamed, René Pareja...
https://pubmed.ncbi.nlm.nih.gov/39570589Actively Recruiting
Phase 3
Age: 18Years +
FEMALE
ID04575935
Minimally Invasive Surgery Versus Laparotomy After Neoadjuvant Chemotherapy for Stage IIIC-IV Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
Led by M.D. Anderson Cancer Center · Updated on 2026-03-05
580
Participants Needed
19
Research Sites
N/A
Total Duration
On this page
Sponsors
M
M.D. Anderson Cancer Center
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating whether minimally invasive surgery (MIS) is as effective as the traditional open surgery method called laparotomy in treating women with advanced stage IIIC-IV ovarian, primary peritoneal, or fallopian tube cancer. This phase III trial focuses on patients receiving chemotherapy before and after surgery, known as neoadjuvant chemotherapy. The study aims to see if MIS can provide similar disease control and quality of life benefits compared to laparotomy. Participants are randomly assigned to one of two groups. One group undergoes MIS within six weeks after completing 3 to 4 cycles of neoadjuvant chemotherapy; if needed, the surgeon may switch to laparotomy during the procedure. The other group receives laparotomy within the same timeframe. After surgery, all patients continue standard chemotherapy within six weeks. The trial includes follow-up visits to monitor health and disease status over several years. During the study, participants have various assessments including quality of life questionnaires and evaluations of surgical outcomes like tumor removal success and complications. Researchers track disease-free survival up to five years and overall survival, along with surgical risks and healthcare costs. Follow-up occurs shortly after post-surgery chemotherapy, then every three months for two years, and every six months for an additional three years to monitor long-term health.
CONDITIONS
Brief Title
Minimally Invasive Surgery After Neoadjuvant Chemotherapy for the Treatment of Stage IIIC-IV Ovarian, Primary Peritoneal, or Fallopian Tube Cancer, LANCE Trial
Who Can Participate
Age: 18Years +
FEMALE
Eligibility Criteria
You may qualify if you...
- Female aged 18 years or older
- Diagnosed with stage IIIC or IV high-grade epithelial ovarian carcinoma, primary peritoneal carcinoma, fallopian tube carcinoma, or high-grade mullerian carcinoma
- Considered a surgical candidate after completing 3 to 4 cycles of platinum-based or investigational neoadjuvant chemotherapy
- Complete radiologic resolution of disease outside the abdomen (pleural effusions allowed per physician discretion)
- Normalized CA-125 levels or CA-125 ≤ 500 with planned diagnostic laparoscopy prior to surgery
- Surgery scheduled within 6 weeks (42 days) after last chemotherapy cycle
- ECOG performance status between 0 and 2
- Signed informed consent and ability to comply with follow-up
- Negative pregnancy test within 14 days prior to surgery
- No other active malignancies in past 5 years except skin basal or squamous cell carcinoma
You will not qualify if you...
- Tumor not suitable for minimally invasive surgery based on imaging, including ascites not improving during chemotherapy, involvement of small bowel, stomach, colon, rectum, diaphragm, spleen, liver, mesentery, or lesser peritoneal sac
- Psychological, familial, social, or geographic conditions preventing study compliance
- Inability to tolerate prolonged Trendelenburg position or pneumoperitoneum
- Any other contraindication to minimally invasive surgery as assessed by clinicians
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Approximately 12 to 18 weeks
Participants receive 3 to 4 cycles of neoadjuvant chemotherapy followed by minimally invasive surgery or laparotomy within 6 weeks after the last chemotherapy cycle. After surgery, participants receive additional standard of care chemotherapy within 6 weeks.
1 surgery visit and chemotherapy visits as per standard of care
Follow-up
Duration - Up to 5 years
Participants are followed up beginning within 6 weeks after completing post-surgery chemotherapy, then every 3 months for the first 2 years, and every 6 months for the next 3 years to monitor health status and disease outcomes.
Visits every 3 months for 2 years, then every 6 months for 3 years
Trial Site Locations
Total: 19 locations
1
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, United States, 33136
Actively Recruiting
2
Cleveland Clinic Foundation - Florida
Weston, Florida, United States, 33331
Actively Recruiting
3
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
4
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
5
NYU Langone Health
Mineola, New York, United States, 11501
Actively Recruiting
6
Columbia University Medical Center
New York, New York, United States, 10032
Actively Recruiting
7
Duke
Durham, North Carolina, United States, 27710
Actively Recruiting
8
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Actively Recruiting
9
St. Luke's University Health Network
Bethlehem, Pennsylvania, United States, 18015
Actively Recruiting
10
Lyndon Baines Johnson General
Houston, Texas, United States, 77026
Actively Recruiting
11
Houston Methodist
Houston, Texas, United States, 77030
Actively Recruiting
12
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
13
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, United States, 53792
Active, Not Recruiting
14
Arthur J.E. Child Comprehensive Cancer Centre - Calgary
Calgary, Canada
Actively Recruiting
15
University Health Network - Princess Margaret Cancer Centre
Toronto, Canada
Actively Recruiting
16
Sant'Orsola Hospital di Bologna
Bologna, Italy, 40138
Actively Recruiting
17
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Rome, Italy, 00168
Actively Recruiting
18
Instituto Nacional de Cancerología (Mexico)
Tlalpan, Mexico
Actively Recruiting
19
Amsterdam UMC - Locatie AMC | H5Zuid 154
Amsterdam, Netherlands
Actively Recruiting
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Research Team
J
Jose A. Rauh-Hain, MD, MPH
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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