RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Phase 2 Clinical Trial of Radiomic Habitat-Directed Radiation Dose Escalation for High-Grade Soft Tissue Sarcoma

Quick Facts

Study Start:2022-05-18

Study Completion:2025-11-26

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05301283

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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

Study Contact

Lauren (Taylor) Michael

CONTACT

813-745-3104

Lauren.Michael@moffitt.org

Principal Investigator

Arash O Naghavi, MD, MS

PRINCIPAL_INVESTIGATOR

Moffitt Cancer Center

Study Locations (Sites)

Moffitt Cancer Center

Tampa, Florida, 33612

United States

Collaborators and Investigators

Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Arash O Naghavi, MD, MS, PRINCIPAL_INVESTIGATOR, Moffitt Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-05-18

Study Completion Date2025-11-26

Study Record Updates

Study Start Date2022-05-18

Study Completion Date2025-11-26

Terms related to this study

Additional Relevant MeSH Terms

High Grade Sarcoma