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NCT03092323 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Soft Tissue Sarcoma of the Extremity, sponsored by Sarcoma Alliance for Research through Collaboration.

Active
Registry status
Phase 2
Development phase
126
Enrollment target
20
Study locations

NCT03092323: Active Phase 2 study of Soft Tissue Sarcoma of the Extremity, sponsored by Sarcoma Alliance for Research through Collaboration.

NCT03092323 is a Phase 2 study of Soft Tissue Sarcoma of the Extremity that is active but no longer recruiting, run by Sarcoma Alliance for Research through Collaboration. The registered enrollment target is 126 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. The trial reports 20 study locations across 18 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03092323, a Phase 2 study of Soft Tissue Sarcoma of the Extremity, is active but no longer recruiting, sponsored by Sarcoma Alliance for Research through Collaboration.

ACTIVE NOT RECRUITING
Registry status
Phase 2
Development phase
126 participants
Enrollment target
20
Study locations

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.

Primary Outcome

Disease recurrence is defined as clinically diagnosed or biopsy-confirmed recurrent sarcoma at a site distant to the primary tumor, including nodal metastasis, loco-regional recurrence, and death without documented recurrence.

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

What the registry record for NCT03092323 still lists

NCT03092323 is an interventional study that assigns participants to a tested intervention. The registered 126 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.

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.

NCT03092323 names 20 study sites across 18 states, led by Massachusetts, Pennsylvania, California.

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.

What interventions are being tested in trial NCT03092323?

The interventions under investigation include: Pembrolizumab (DRUG).

Who is sponsoring clinical trial NCT03092323?

This trial is sponsored by Sarcoma Alliance for Research through Collaboration, which has 20 total clinical trials registered on ClinicalTrials.gov.

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.

How this trial's enrollment target compares

Where NCT03092323's enrollment target sits among peer trials

126 556th of 2000 higher than 1,443 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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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Source: ClinicalTrials.gov NCT03092323, the US trial registry maintained by the National Library of Medicine. NCT03092323 (mid enrollment · wide site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.