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ACTIVE NOT RECRUITING Phase 2

A Randomized Trial of Pembrolizumab & Radiotherapy Versus Radiotherapy in High-Risk Soft Tissue Sarcoma of the Extremity

NCT03092323 · View on ClinicalTrials.gov ↗

Study Summary

This is an open-label, multi-institutional phase II randomized study comparing neoadjuvant radiotherapy followed by surgical resection to neoadjuvant pembrolizumab with concurrent radiotherapy, followed by surgical resection and adjuvant pembrolizumab. The total duration of pembrolizumab will be one year in the experimental arm.

Interventions

  • DRUG Pembrolizumab

Study Locations (20)

Massachusetts

  • Massachusetts General Hospital Cancer Center — Boston
  • Dana-Farber Cancer Institute — Boston

Pennsylvania

  • University of Pennsylvania- Abramson Cancer Center — Philadelphia
  • University of Pittsburgh (UPMC Hillman Cancer Center) — Pittsburgh

California

  • University of California Los Angeles — Los Angeles

Florida

  • Mayo Clinic- Florida — Jacksonville

Iowa

  • University of Iowa Hospitals & Clinics — Iowa City

Kansas

  • University of Kansas Medical Center — Kansas City

Maryland

  • Johns Hopkins University — Baltimore

Michigan

  • University of Michigan — Ann Arbor

Trial Details

FieldValue
Enrollment Target 126 participants
Start Date 2017-07-19
Est. Completion 2028-09-01
Phase Phase 2

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03092323

The ClinicalTrials.gov registry entry for NCT03092323 describes a study currently listed as active not recruiting. It is categorized as Phase 2, 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 126 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sarcoma Alliance for Research through Collaboration, which has 37 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Soft Tissue Sarcoma of the Extremity appearing as the primary indexed condition, and to 1 intervention — of which Pembrolizumab 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: NCT03092323 reports 20 study locations spanning 18 distinct geographic areas — top geographies include Massachusetts, Pennsylvania, California. 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 NCT03092323 about?

NCT03092323 is a clinical study titled "A Randomized Trial of Pembrolizumab & Radiotherapy Versus Radiotherapy in High-Risk Soft Tissue Sarcoma of the Extremity". This is an open-label, multi-institutional phase II randomized study comparing neoadjuvant radiotherapy followed by surgical resection to neoadjuvant pembrolizumab with concurrent radiotherapy, followed by surgical resection and adjuvant pembrolizumab. The total duration of pembrolizumab will be one...

What is the current status of trial NCT03092323?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 126 participants. The study started on 2017-07-19. Estimated completion is 2028-09-01.

What conditions does trial NCT03092323 study?

This clinical trial studies the following conditions: Soft Tissue Sarcoma of the Extremity. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03092323?

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

Who is sponsoring clinical trial NCT03092323?

This trial is sponsored by Sarcoma Alliance for Research through Collaboration, which has 37 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT03092323 being conducted?

This trial has 20 study locations across California, Florida, Iowa, Kansas, Maryland. 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