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NCT04575935 · ClinicalTrials.gov registry record · Phase 3
Minimally Invasive Surgery After Neoadjuvant Chemotherapy for the Treatment of Stage IIIC-IV Ovarian, Primary Peritoneal, or Fallopian Tube Cancer, LANCE Trial
A Phase 3 study of Ovarian Endometrioid Adenocarcinoma and Advanced Ovarian Carcinoma, sponsored by M.D. Anderson Cancer Center.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 580
- Enrollment target
- 19
- Study locations
NCT04575935: Recruiting Phase 3 study of Ovarian Endometrioid Adenocarcinoma and Advanced Ovarian Carcinoma, sponsored by M.D. Anderson Cancer Center.
NCT04575935 is a Phase 3 study of Ovarian Endometrioid Adenocarcinoma and Advanced Ovarian Carcinoma that is actively recruiting participants, run by M.D. Anderson Cancer Center. The registered enrollment target is 580 participants, above the 263-participant average among 15 other Ovarian Endometrioid Adenocarcinoma trials with a reported enrollment target (121% higher). The trial reports 19 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04575935, a Phase 3 study of Ovarian Endometrioid Adenocarcinoma and Advanced Ovarian Carcinoma, is actively recruiting participants, sponsored by M.D. Anderson Cancer Center.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 580 participants
- Enrollment target
- 19
- Study locations
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.
Primary Outcome
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).
Conditions Studied
Interventions
- OTHER Quality-of-Life Assessment
- OTHER Questionnaire Administration
- DRUG Chemotherapy
- PROCEDURE Minimally Invasive Surgery
- PROCEDURE Laparotomy
Study Locations (19)
Other
- Arthur J.E. Child Comprehensive Cancer Centre - Calgary - Calgary
- University Health Network - Princess Margaret Cancer Centre - Toronto
- Sant'Orsola Hospital di Bologna - Bologna
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Rome
- Instituto Nacional de Cancerología (Mexico) - Tlalpan
- Amsterdam UMC - Locatie AMC | H5Zuid 154 - Amsterdam
Texas
- Lyndon Baines Johnson General - Houston
- Houston Methodist - Houston
- M D Anderson Cancer Center - Houston
Florida
- University of Miami Miller School of Medicine-Sylvester Cancer Center - Miami
- Cleveland Clinic Foundation - Florida - Weston
Massachusetts
- Massachusetts General Hospital - Boston
- Dana Farber Cancer Institute - Boston
New York
- NYU Langone Health - Mineola
- Columbia University Medical Center - New York
North Carolina
- Duke - Durham
Ohio
- Cleveland Clinic - Cleveland
Pennsylvania
- St. Luke's University Health Network - Bethlehem
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 580 participants |
| Start Date | 2020-08-05 |
| Est. Completion | 2028-12-31 |
| Phase | Phase 3 |
What NCT04575935 shows while recruiting
NCT04575935 is an interventional study that assigns participants to a tested intervention. The registered 580 participants enrollment target is mid-sized for trials with a published cap, above the 263-participant average among 15 other Ovarian Endometrioid Adenocarcinoma trials with a reported enrollment target (121% higher).
The record links to 10 conditions, with Ovarian Endometrioid Adenocarcinoma appearing as the primary indexed condition, and to 5 interventions - of which Quality-of-Life Assessment is the first listed.
NCT04575935 lists 19 locations in 9 states (Other, Texas, Florida).
Frequently Asked Questions
What is clinical trial NCT04575935 about?
NCT04575935 is a clinical study titled "Minimally Invasive Surgery After Neoadjuvant Chemotherapy for the Treatment of Stage IIIC-IV Ovarian, Primary Peritoneal, or Fallopian Tube Cancer, LANCE Trial". 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 i...
What is the current status of trial NCT04575935?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 580 participants. The study started on 2020-08-05. Estimated completion is 2028-12-31.
What conditions does trial NCT04575935 study?
This clinical trial studies the following conditions: Ovarian Endometrioid Adenocarcinoma, Advanced Ovarian Carcinoma, Ovarian Serous Adenocarcinoma, Ovarian Clear Cell Adenocarcinoma, Fallopian Tube Clear Cell Adenocarcinoma.
What interventions are being tested in trial NCT04575935?
The interventions under investigation include: Quality-of-Life Assessment (OTHER), Questionnaire Administration (OTHER), Chemotherapy (DRUG), Minimally Invasive Surgery (PROCEDURE), Laparotomy (PROCEDURE).
Who is sponsoring clinical trial NCT04575935?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04575935 being conducted?
This trial has 19 study locations across Florida, Massachusetts, New York, North Carolina, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04575935's enrollment target sits among peer trials
580 4th of 15 higher than 12 of 15 other Ovarian Endometrioid Adenocarcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Ovarian Endometrioid Adenocarcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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