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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 8 months

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

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor

543 Previous Clinical Trials

135,439 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has Intensity Modulated Radiation Therapy (IMRT) received the endorsement of the FDA?

"As a Phase 2 trial, indicating that there is some evidence for safety but not necessarily efficacy, Intensity Modulated Radiation Therapy (IMRT) was rated a two on our team's scale."

Answered by AI

What is the current size of the cohort participating in this experiment?

"Indeed, clinicaltrials.gov states that this medical trial is actively recruiting participants; the study was first posted on May 18th 2022 and modified lastly on November 16th 2022 with a goal of 43 patients being recruited from a single location."

Answered by AI

Is enrollment still available for this clinical experiment?

"Affirmative. The clinicaltrials.gov website indicates that this experiment is actively seeking enrollees, with the original post date being May 18th 2022 and the most recent edit occurring on November 16th of the same year. Altogether, 43 patients will be admitted across one participating medical site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2022. "Habitat Escalated Adaptive Therapy (HEAT), With Neoadjuvant Radiation for Soft Tissue Sarcoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05301283.

All > Soft Tissue Sarcoma