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NCT05301283 · ClinicalTrials.gov registry record · Phase 2

Habitat Escalated Adaptive Therapy (HEAT), With Neoadjuvant Radiation for Soft Tissue Sarcoma

A Phase 2 study of High Grade Sarcoma, sponsored by H. Lee Moffitt Cancer Center and Research Institute.

Recruiting
Registry status
Phase 2
Development phase
43
Enrollment target
1
Study location

NCT05301283: Recruiting Phase 2 study of High Grade Sarcoma, sponsored by H. Lee Moffitt Cancer Center and Research Institute.

NCT05301283 is a Phase 2 study of High Grade Sarcoma that is actively recruiting participants, run by H. Lee Moffitt Cancer Center and Research Institute. The registered enrollment target is 43 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (68% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05301283, a Phase 2 study of High Grade Sarcoma, is actively recruiting participants, sponsored by H. Lee Moffitt Cancer Center and Research Institute.

RECRUITING
Registry status
Phase 2
Development phase
43 participants
Enrollment target
1
Study location

Study Summary

The purpose of the study is to utilize radiomic images to precisely locate areas of tumor that can be treated with dose escalation radiation therapy.

Primary Outcome

Percentage of participants with Favorable Pathologic Response (FPR): tumor necrosis \>/= 95% at time of surgery. FPR is associated with improved R0 resection rates, local control, distant control, and overall survival. Therefore, FPR acts as an early surrogate for outcome.

Conditions Studied

Interventions

  • RADIATION Intensity Modulated Radiation Therapy (IMRT)
  • DIAGNOSTIC_TEST MRI

Study Locations (1)

Florida

  • Moffitt Cancer Center - Tampa

Trial Details

FieldValue
Enrollment Target 43 participants
Start Date 2022-05-18
Est. Completion 2026-08
Phase Phase 2

What NCT05301283 shows while recruiting

NCT05301283 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 43 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (68% lower).

The record links to 1 condition, with High Grade Sarcoma appearing as the primary indexed condition, and to 2 interventions - of which Intensity Modulated Radiation Therapy (IMRT) is the first listed.

NCT05301283 reports a single indexed study location in Florida.

Frequently Asked Questions

What is clinical trial NCT05301283 about?

NCT05301283 is a clinical study titled "Habitat Escalated Adaptive Therapy (HEAT), With Neoadjuvant Radiation for Soft Tissue Sarcoma". The purpose of the study is to utilize radiomic images to precisely locate areas of tumor that can be treated with dose escalation radiation therapy.

What is the current status of trial NCT05301283?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 43 participants. The study started on 2022-05-18. Estimated completion is 2026-08.

What conditions does trial NCT05301283 study?

This clinical trial studies the following conditions: High Grade Sarcoma.

What interventions are being tested in trial NCT05301283?

The interventions under investigation include: Intensity Modulated Radiation Therapy (IMRT) (RADIATION), MRI (DIAGNOSTIC_TEST).

Who is sponsoring clinical trial NCT05301283?

This trial is sponsored by H. Lee Moffitt Cancer Center and Research Institute, which has 502 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05301283 being conducted?

This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

How this trial's enrollment target compares

Where NCT05301283's enrollment target sits among peer trials

43 1332nd of 2000 higher than 663 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 NCT05301283, the US trial registry maintained by the National Library of Medicine. NCT05301283 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.