Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

RECRUITING Phase 3

Surgery With or Without Neoadjuvant Chemotherapy in High Risk RetroPeritoneal Sarcoma

NCT04031677 · View on ClinicalTrials.gov ↗

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.

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

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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. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 250 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is European Organisation for Research and Treatment of Cancer - EORTC, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04031677 reports 20 study locations spanning 6 distinct geographic areas — top geographies include Connecticut, California, Alabama. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04031677?

The interventions under investigation include: Surgery (PROCEDURE), Preoperative chemotherapy (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04031677?

This trial is sponsored by European Organisation for Research and Treatment of Cancer - EORTC, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial