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
|Condition or disease||Intervention/treatment||Phase|
|High Grade Sarcoma||Radiation: Intensity Modulated Radiation Therapy (IMRT) Diagnostic Test: MRI||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||43 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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.
- 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.
- 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.
- Overall Survival [ Time Frame: Up to 8 months ]Overall Survival defined as the time from date of initial treatment to date of death.
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
|Contact: Lauren (Taylor) Michael||813-745-3104||Lauren.Michael@moffitt.org|
|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|
|Principal Investigator:||Arash O Naghavi, MD, MS||Moffitt Cancer Center|