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

ConditionHigh Grade Sarcoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorH. Lee Moffitt Cancer Center and Research Institute

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Provision of signed and dated informed consent form

Stated willingness to comply with all study procedures and availability for the duration of the study

For women of childbearing potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional 52 weeks after the end of radiation.

For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner 52 weeks after radiation.

Disqualifiers

Contraindications to an MRI

Positive urine pregnancy test

Gross total excision of primary STS, including an unplanned excision

Superficial sarcoma located primarily in the subcutaneous or cutaneous tissue

Trial design

Design model

Single group

Treatments tested in this trial

  • Intensity Modulated Radiation Therapy (IMRT)

    Radiation

    Participants will be treated with intensity modulated radiation therapy (IMRT) with photons, which is FDA (U.S. Food and Drug Administration) approved radiation delivery system.

  • MRI

    Diagnostic test

    Participants will receive pretreatment diagnostic MRIs to generate MRI habitats. These images will identify radioresistant cells within tumor.

Treatment groups

43 Participants
are divided into 1 treatment group
Group A: TreatmentExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Rate of Favorable Pathologic Response (FPR)

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.

Time frame
Week 10

Secondary outcomes

1

Percentage of tumor with clear margin and positive margin

Review of final tumor margin of the surgical specimen, defined as tumor at ink margin, will be conducted by pathologist. A clear margin (R0) or a positive margin (R1/R2) will be designated, along with the location of the margin, which will be radiographically correlated to the habitat . Surgical margins are independent predictors for local control.

Time frame
Weeks 10-13

Other outcomes

1

Disease Control Rate

Disease control rate defined as the sum of complete response, partial response, and stable disease rates.

Time frame
Up to 6 months
2

Overall Survival

Overall Survival defined as the time from date of initial treatment to date of death.

Time frame
Up to 8 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

H. Lee Moffitt Cancer Center and Research Institute

Lead sponsor

Viewray Inc.

Collaborator

Source ClinicalTrials.gov
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