What is the mechanism of action of this treatment?

The most common treatments for sarcoma include surgery, chemotherapy, and radiation therapy. Surgery aims to remove the tumor entirely, which is crucial for local control of the disease. Chemotherapy uses drugs to kill cancer cells or stop them from growing, and is often used for high-grade or metastatic sarcomas. Radiation therapy involves using high-energy rays to destroy cancer cells. Dose escalation radiation therapy, which increases the radiation dose to specific tumor areas identified by radiomic imaging, is particularly important as it allows for more precise targeting of the tumor while sparing surrounding healthy tissue. This targeted approach can potentially improve treatment efficacy and reduce side effects, offering better outcomes for sarcoma patients.

What side effects are associated with this type of intervention?

Common treatments for sarcoma, particularly those involving dose escalation radiation therapy, can cause side effects such as fatigue, skin irritation, and localized pain. Targeted dose escalation may increase the severity of these localized side effects, potentially leading to more significant damage to surrounding healthy tissues, higher incidence of radiation dermatitis, and more pronounced fatigue. Long-term complications such as fibrosis or secondary malignancies may also be more likely due to the higher radiation doses.

What prior FDA approvals exist?

The FDA has approved several treatments for sarcoma, including chemotherapeutic agents like doxorubicin and ifosfamide, which are often used in combination with radiation therapy. Additionally, targeted therapies such as pazopanib, a tyrosine kinase inhibitor, have been approved for advanced soft tissue sarcoma. While specific FDA approvals for dose escalation radiation therapy using radiomic imaging are not detailed, standard radiation therapy remains a cornerstone in sarcoma treatment, often combined with chemotherapy to enhance efficacy.

What other types of research exist?

Promising novel alternatives to Dose Escalation Radiation Therapy for Sarcoma patients include: 1) Immunotherapy, such as immune checkpoint inhibitors (e.g., pembrolizumab) which have shown efficacy in various sarcomas. 2) Targeted therapies, including tyrosine kinase inhibitors and mTOR inhibitors, which can be effective in specific sarcoma subtypes. 3) Advanced imaging techniques like PET/MRI using novel radiotracers for better tumor localization and treatment planning. These alternatives offer potential for improved outcomes and personalized treatment strategies.

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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

Must not have

Prior radiation to the region of the study cancer that would result in overlap of radiation therapy fields

Superficial sarcoma located primarily in the subcutaneous or cutaneous tissue

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 8 months

Awards & highlights

No Placebo-Only Group

Summary

This trial uses advanced imaging to find specific parts of a tumor for higher radiation doses, aiming to improve treatment for patients with tumors by targeting critical areas more effectively.

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.

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.

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

Select...

My cancer can be surgically removed.

Select...

My cancer is localized and has not spread to distant parts of my body.

Select...

My diagnosis is high-grade Soft Tissue Sarcoma in the deep trunk/extremity.

Select...

I can care for myself but may not be able to do heavy physical work.

Select...

My cancer can be seen or measured on scans.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I've had radiation in the same area as my current cancer.

Select...

My sarcoma is just under my skin or in it.

Select...

I had surgery to remove my soft tissue sarcoma completely.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Rate of Favorable Pathologic Response (FPR)

Secondary study objectives

Percentage of tumor with clear margin and positive margin

Other study objectives

Disease Control Rate

Overall Survival

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~2810

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for sarcoma include surgery, chemotherapy, and radiation therapy. Surgery aims to remove the tumor entirely, which is crucial for local control of the disease. Chemotherapy uses drugs to kill cancer cells or stop them from growing, and is often used for high-grade or metastatic sarcomas. Radiation therapy involves using high-energy rays to destroy cancer cells. Dose escalation radiation therapy, which increases the radiation dose to specific tumor areas identified by radiomic imaging, is particularly important as it allows for more precise targeting of the tumor while sparing surrounding healthy tissue. This targeted approach can potentially improve treatment efficacy and reduce side effects, offering better outcomes for sarcoma patients.

The tumor core boost study: A feasibility study of radical dose escalation to the central part of large tumors with an integrated boost in the palliative treatment setting.Treatment of uterine sarcoma at the University of Florence from 1980-2001.Radiation therapy for the treatment of locally advanced and metastatic prostate cancer.