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NCT04031677 · ClinicalTrials.gov registry record · Phase 3
Surgery With or Without Neoadjuvant Chemotherapy in High Risk RetroPeritoneal Sarcoma
A Phase 3 study of Leiomyosarcoma and Liposarcoma, sponsored by European Organisation for Research and Treatment of Cancer - EORTC.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 250
- Enrollment target
- 20
- Study locations
NCT04031677: Recruiting Phase 3 study of Leiomyosarcoma and Liposarcoma, sponsored by European Organisation for Research and Treatment of Cancer - EORTC.
NCT04031677 is a Phase 3 study of Leiomyosarcoma and Liposarcoma that is actively recruiting participants, run by European Organisation for Research and Treatment of Cancer - EORTC. The registered enrollment target is 250 participants, above the 106-participant average among 16 other Leiomyosarcoma trials with a reported enrollment target (136% higher). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04031677, a Phase 3 study of Leiomyosarcoma and Liposarcoma, is actively recruiting participants, sponsored by European Organisation for Research and Treatment of Cancer - EORTC.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 250 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a multicenter, randomized, open label phase lll trial to assess whether preoperative chemotherapy, as an adjunct to curative-intent surgery, improves the prognosis of high risk DDLPS (dedifferentiated Liposarcoma) and LMS (Leiomyosarcoma) patients as measured by disease free survival. After confirmation of eligibility criteria, patients will be randomized to either the standard arm or experimental arm.
Primary Outcome
Disease free survival will be measured from the date of randomization (as reference) to the date of recurrence or death, whichever occurs first.
Conditions Studied
Interventions
- PROCEDURE Surgery
- DRUG Preoperative chemotherapy
Study Locations (20)
Connecticut
- Smilow Cancer Hospital-Derby Care Center - Derby
- Smilow Cancer Hospital Care Center-Fairfield - Fairfield
- Smilow Cancer Hospital Care Center at Glastonbury - Glastonbury
- Smilow Cancer Hospital Care Center at Greenwich - Greenwich
- Smilow Cancer Hospital Care Center - Guiford - Guilford
- Smilow Cancer Hospital Care Ctr at Saint Francis - Hartford
- Yale University - New Haven
- Yale-New Haven Hospital North Haven Medical Center - North Haven
- Smilow Cancer Hospital Care Center at Long Ridge - Stamford
- Smilow Cancer Hospital Care Center-Trumbull - Trumbull
- Smilow Cancer Hospital-Waterbury Care Center - Waterbury
- Smilow Cancer Hospital Care Center - Waterford - Waterford
California
- City of Hope Comprehensive Cancer Center - Duarte
- UCI Health-Chao Family Comp CC and Ambulatory Care - Irvine
- UC San Diego Moores Cancer Center - La Jolla
- UC Irvine Health/Chao Family Comprehensive Ca Ctr - Orange
Alabama
- University of Alabama at Birmingham Cancer Center - Birmingham
Arizona
- Mayo Clinic Hospital in Arizona - Phoenix
Colorado
- UCHealth University of Colorado Hospital - Aurora
Florida
- Univ of Florida Health Science Ctr - Gainesville - Gainesville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 250 participants |
| Start Date | 2021-01-20 |
| Est. Completion | 2028-04-21 |
| Phase | Phase 3 |
What NCT04031677 shows while recruiting
NCT04031677 is an interventional study that assigns participants to a tested intervention. The registered 250 participants enrollment target is mid-sized for trials with a published cap, above the 106-participant average among 16 other Leiomyosarcoma trials with a reported enrollment target (136% higher).
The record links to 3 conditions, with Leiomyosarcoma appearing as the primary indexed condition, and to 2 interventions - of which Surgery is the first listed.
NCT04031677 names 20 study sites across 6 states, led by Connecticut, California, Alabama.
Frequently Asked Questions
What is clinical trial NCT04031677 about?
NCT04031677 is a clinical study titled "Surgery With or Without Neoadjuvant Chemotherapy in High Risk RetroPeritoneal Sarcoma". This is a multicenter, randomized, open label phase lll trial to assess whether preoperative chemotherapy, as an adjunct to curative-intent surgery, improves the prognosis of high risk DDLPS (dedifferentiated Liposarcoma) and LMS (Leiomyosarcoma) patients as measured by disease free survival. After...
What is the current status of trial NCT04031677?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 250 participants. The study started on 2021-01-20. Estimated completion is 2028-04-21.
What conditions does trial NCT04031677 study?
This clinical trial studies the following conditions: Leiomyosarcoma, Liposarcoma, Retroperitoneal Sarcoma.
What interventions are being tested in trial NCT04031677?
The interventions under investigation include: Surgery (PROCEDURE), Preoperative chemotherapy (DRUG).
Who is sponsoring clinical trial NCT04031677?
This trial is sponsored by European Organisation for Research and Treatment of Cancer - EORTC, which has 15 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04031677 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Leiomyosarcoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04031677's enrollment target sits among peer trials
250 4th of 16 higher than 13 of 16 other Leiomyosarcoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Leiomyosarcoma 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.
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