This is the classic website, which will be retired eventually. Please visit the modernized ClinicalTrials.gov instead.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05301283
Recruitment Status : Recruiting
First Posted : March 29, 2022
Last Update Posted : November 9, 2023
Sponsor:
Collaborator:
Viewray Inc.
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
High Grade Sarcoma Radiation: Intensity Modulated Radiation Therapy (IMRT) Diagnostic Test: MRI Phase 2

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 43 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 2 Clinical Trial of Radiomic Habitat-Directed Radiation Dose Escalation for High-Grade Soft Tissue Sarcoma
Actual Study Start Date : May 18, 2022
Estimated Primary Completion Date : March 31, 2024
Estimated Study Completion Date : March 31, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Treatment

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.

 Radiation: Intensity Modulated Radiation Therapy (IMRT)
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.

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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Rate of Favorable Pathologic Response (FPR) [ Time Frame: Week 10 ]
    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 :
  1. Percentage of tumor with clear margin and positive margin [ Time Frame: Weeks 10-13 ]
    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.


Other Outcome Measures:
  1. Disease Control Rate [ Time Frame: Up to 6 months ]
    Disease control rate defined as the sum of complete response, partial response, and stable disease rates.

  2. Overall Survival [ Time Frame: Up to 8 months ]
    Overall Survival defined as the time from date of initial treatment to date of death.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05301283


Contacts
Layout table for location contacts
Contact: Lauren (Taylor) Michael 813-745-3104 Lauren.Michael@moffitt.org

Locations
Layout table for location information
United States, Florida
Moffitt Cancer Center Recruiting
Tampa, Florida, United States, 33612
Contact: Lauren (Taylor) Michael    813-745-3104    Lauren.Michael@moffitt.org   
Principal Investigator: Arash O Naghavi, MD, MS         
Sub-Investigator: Marilyn Bui, MD, PhD         
Sub-Investigator: Ricardo Gonzalez, PhD         
Sub-Investigator: Nainesh Parikh, MD, MBA         
Sponsors and Collaborators
H. Lee Moffitt Cancer Center and Research Institute
Viewray Inc.
Investigators
Layout table for investigator information
Principal Investigator: Arash O Naghavi, MD, MS Moffitt Cancer Center
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Layout table for additonal information
Responsible Party: H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier: NCT05301283    
Other Study ID Numbers: MCC-21136
First Posted: March 29, 2022    Key Record Dates
Last Update Posted: November 9, 2023
Last Verified: November 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms