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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 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.

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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.

Conditions Studied

Leiomyosarcoma Liposarcoma Retroperitoneal Sarcoma

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

FieldValue
Enrollment Target 250 participants
Start Date 2021-01-20
Est. Completion 2028-04-21
Phase Phase 3

Sponsor

European Organisation for Research and Treatment of Cancer - EORTC

15 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04031677

The ClinicalTrials.gov registry entry for NCT04031677 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 250 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 106-participant average among 16 other Leiomyosarcoma trials with a reported enrollment target (136% higher). The listed sponsor is European Organisation for Research and Treatment of Cancer - EORTC, which has 15 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 6 distinct geographic areas - top geographies include 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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.