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Radiation Therapy

Adaptive Radiation Therapy for Sarcoma

Phase 2
Recruiting
Led By Arash O Naghavi, MD, MS
Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Primary site deemed resectable prior to the start of trial
American Joint Committee on Cancer (AJCC) 8th edition staging T1-4 N0 M0, no evidence of distant metastases
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 8 months
Awards & highlights

Study Summary

This trial is using images to find areas of tumors to treat with higher doses of radiation.

Who is the study for?
This trial is for adults with high-grade Soft Tissue Sarcoma of the deep trunk/extremity, who haven't had prior radiation in the area or complete surgical removal. They must be able to undergo surgery after radiation, have no distant cancer spread, and agree to use effective contraception. Pregnant women and those unable to get MRI scans are excluded.Check my eligibility
What is being tested?
The HEAT study tests a targeted radiation therapy approach using IMRT guided by radiomic images from MRIs. The goal is to escalate doses precisely at tumor sites while sparing healthy tissue, before patients proceed to surgery.See study design
What are the potential side effects?
IMRT may cause skin redness, irritation or peeling at the treatment site, fatigue, swelling in treated areas and potential late effects like fibrosis or joint stiffness depending on the area treated.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer can be surgically removed.
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My cancer is localized and has not spread to distant parts of my body.
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My diagnosis is high-grade Soft Tissue Sarcoma in the deep trunk/extremity.
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I can care for myself but may not be able to do heavy physical work.
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My cancer can be seen or measured on scans.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 8 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 8 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Rate of Favorable Pathologic Response (FPR)
Secondary outcome measures
Percentage of tumor with clear margin and positive margin
Other outcome measures
Disease Control Rate
Overall Survival

Trial Design

1Treatment groups
Experimental Treatment
Group I: TreatmentExperimental Treatment2 Interventions
Participants will receive pretreatment diagnostic MRIs to generate MRI habitats (images of tumor regions/subregions in different sequences). These images will identify radioresistant cells within the tumor to allow for more precise and higher doses of radiation to the resistant cells. Participants will then be treated with neoadjuvant external beam radiation by using the intensity modulated radiation (IMRT) technique, with dose painting (simultaneous integrated boost/SIB) to 70 Gray Units (Gy), 60 Gy, and 50 Gy in 25 fractions for habitats 1, 2, and 3, respectively.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Intensity Modulated Radiation Therapy (IMRT)
2010
Completed Phase 1
~60
MRI
2009
Completed Phase 2
~1370

Find a Location

Who is running the clinical trial?

H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
546 Previous Clinical Trials
135,549 Total Patients Enrolled
8 Trials studying Sarcoma
207 Patients Enrolled for Sarcoma
Viewray Inc.Industry Sponsor
12 Previous Clinical Trials
1,046 Total Patients Enrolled
Arash O Naghavi, MD, MSPrincipal InvestigatorMoffitt Cancer Center

Media Library

Neoadjuvant Radiation (Radiation Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05301283 — Phase 2
Sarcoma Research Study Groups: Treatment
Sarcoma Clinical Trial 2023: Neoadjuvant Radiation Highlights & Side Effects. Trial Name: NCT05301283 — Phase 2
Neoadjuvant Radiation (Radiation Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05301283 — Phase 2
~0 spots leftby Jun 2024
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