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

Primary Purpose

High Grade Sarcoma

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Intensity Modulated Radiation Therapy (IMRT)
MRI
Sponsored by
H. Lee Moffitt Cancer Center and Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for High Grade Sarcoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.
  • Agreement to adhere to Lifestyle Considerations (as outlined in protocol) throughout study duration.
  • Pathologically (histologically or cytologically) proven diagnosis of high-grade Soft Tissue Sarcoma (STS) of the deep trunk and extremity. Clinical evidence should be documented, and may consist of pathology or imaging, and should be sufficient to estimate the size of the primary (for T stage)
  • 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
  • Patients must have clinically or radiographically evident measurable disease at the primary site.
  • Pre-Radiation Therapy (RT) and post-RT MRI within 4 weeks of the start and completion of RT, respectively
  • Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 3.
  • Deemed a surgical candidate
  • Participant agrees to blood and plasma preservation for future analysis.

Exclusion Criteria:

  • 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
  • Prior radiation to the region of the study cancer that would result in overlap of radiation therapy fields.
  • Participants with a medical condition or social situation that, at the discretion of the principal investigator, would preclude them from completion of the trial.

Sites / Locations

  • Moffitt Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
March 18, 2022
Last Updated
October 17, 2023
Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Collaborators
Viewray Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05301283
Brief Title
Habitat Escalated Adaptive Therapy (HEAT), With Neoadjuvant Radiation for Soft Tissue Sarcoma
Official Title
Phase 2 Clinical Trial of Radiomic Habitat-Directed Radiation Dose Escalation for High-Grade Soft Tissue Sarcoma
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 18, 2022 (Actual)
Primary Completion Date
March 31, 2024 (Anticipated)
Study Completion Date
March 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Collaborators
Viewray Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
High Grade Sarcoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
43 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Arm Description
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.
Intervention Type
Radiation
Intervention Name(s)
Intensity Modulated Radiation Therapy (IMRT)
Intervention Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
MRI
Intervention Description
Participants will receive pretreatment diagnostic MRIs to generate MRI habitats. These images will identify radioresistant cells within tumor.
Primary Outcome Measure Information:
Title
Rate of Favorable Pathologic Response (FPR)
Description
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 Outcome Measure Information:
Title
Percentage of tumor with clear margin and positive margin
Description
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 Pre-specified Outcome Measures:
Title
Disease Control Rate
Description
Disease control rate defined as the sum of complete response, partial response, and stable disease rates.
Time Frame
Up to 6 months
Title
Overall Survival
Description
Overall Survival defined as the time from date of initial treatment to date of death.
Time Frame
Up to 8 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Agreement to adhere to Lifestyle Considerations (as outlined in protocol) throughout study duration. Pathologically (histologically or cytologically) proven diagnosis of high-grade (grade 2 or 3) Soft Tissue Sarcoma (STS) of the deep trunk and/or extremity. Clinical evidence should be documented, and may consist of pathology or imaging, and should be sufficient to estimate the size of the primary (for T stage) 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 Patients must have clinically or radiographically evident measurable disease at the primary site. Pre-Radiation Therapy (RT) MRI within 4 weeks of the start of RT. Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 3. Deemed a surgical candidate Participant agrees to blood and plasma preservation for future analysis. Exclusion Criteria: 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 Prior radiation to the region of the study cancer that would result in overlap of radiation therapy fields. Participants with a medical condition or social situation that, at the discretion of the principal investigator, would preclude them from completion of the trial.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lauren (Taylor) Michael
Phone
813-745-3104
Email
Lauren.Michael@moffitt.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arash O Naghavi, MD, MS
Organizational Affiliation
Moffitt Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Moffitt Cancer Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lauren (Taylor) Michael
Phone
813-745-3104
Email
Lauren.Michael@moffitt.org
First Name & Middle Initial & Last Name & Degree
Arash O Naghavi, MD, MS
First Name & Middle Initial & Last Name & Degree
Marilyn Bui, MD, PhD
First Name & Middle Initial & Last Name & Degree
Ricardo Gonzalez, PhD
First Name & Middle Initial & Last Name & Degree
Nainesh Parikh, MD, MBA

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://www.moffitt.org/clinical-trials-research/clinical-trials/
Description
Moffitt Cancer Center Clinical Trials website

Learn more about this trial

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

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