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/39570589/Actively Recruiting
Led by M.D. Anderson Cancer Center · Updated on 2026-03-05
580
Participants Needed
19
Research Sites
N/A
Total Duration
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
Minimally Invasive Surgery After Neoadjuvant Chemotherapy for the Treatment of Stage IIIC-IV Ovarian, Primary Peritoneal, or Fallopian Tube Cancer, LANCE Trial
J
Jose A. Rauh-Hain, MD, MPH
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M.D. Anderson Cancer Center
Lead Sponsor
National Cancer Institute (NCI)
Collaborating Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | MIS after NACT | Laparotomy after NACT | Primary debulking |
|---|---|---|---|
| What it is | A minimally invasive (laparoscopic) cytoreductive surgery performed after neoadjuvant chemotherapy, randomized in the phase III LANCE trial | An open (laparotomy) cytoreductive surgery performed after neoadjuvant chemotherapy, randomized in the same trial | Primary (up‑front) cytoreductive surgery is recommended for patients with advanced ovarian cancer when complete resection is likely |
| Role in trial | Investigational surgical approach to test feasibility and outcomes compared to open surgery | Active comparator (standard open surgery following NACT) in the trial | Current guideline‑based treatment alternative outside trial when optimal debulking is expected |
| Primary use | To achieve disease‑free survival and improved quality of life with less invasive surgery | To remove tumor via open surgery after NACT aiming for cytoreduction | Standard approach to attempt complete tumor removal before chemotherapy |
| How it is performed | Laparoscopic surgery performed within six weeks after last NACT cycle, followed by standard chemotherapy | Open abdominal surgery performed within six weeks after NACT, followed by standard chemotherapy | Open cytoreductive surgery before chemotherapy when complete resection is feasible |
| Evidence status | Being evaluated for non‑inferiority in disease‑free survival and overall survival in this phase III trial | Standard open surgical route following NACT; outcomes established historically but under direct comparison in this trial | Fundamental standard approach with evidence of survival benefit when complete cytoreduction feasible |
| Important risks | Risks include conversion to open surgery and typical surgical complications | Risks include higher surgical morbidity typical for open abdominal surgery | Risks inherent to major open surgery before chemotherapy, including perioperative morbidity |
| Important limitations | Long‑term survival and recurrence outcomes are not yet published; feasibility depends on achieving complete cytoreduction via MIS | Open surgery may result in increased recovery time and morbidity compared with less invasive approaches | Not randomized in this trial; patient selection criteria differ and stage timing makes direct comparison challenging |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
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
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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J Alejandro Rauh-Hain, Alexander Melamed, René Pareja...
https://pubmed.ncbi.nlm.nih.gov/39570589/M.D. Anderson Cancer Center
Lead Sponsor
National Cancer Institute (NCI)
Collaborating Sponsor