Study of Magnetic Resonance Image and Computed Tomography-Guided Stereotactic Body Radiation Therapy for Abdominopelvic Sarcomas (MARS Trial)

Trial Title: Study of Magnetic Resonance Image and Computed Tomography-Guided Stereotactic Body Radiation Therapy for Abdominopelvic Sarcomas (MARS Trial)

NCT ID: NCT06436612

Condition: Abdominopelvic Sarcomas

Conditions: Official terms:
Sarcoma

Study type: Interventional

Study phase: Phase 2

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Radiation
Intervention name: Magnetic Resonance Image and Computed Tomography-Guided Stereotactic Body Radiation Therapy
Description: stereotactic body radiation therapy (SBRT) administered over 5 days x 5.0 - 6.0 Gy for patients with abdominopelvic sarcomas.
Arm group label: Arm I

Other name: Pre-operative stereotactic body radiation therapy (SBRT)

Summary: Recent advances in radiation treatment have allowed for higher doses per treatment to be delivered safely. This study plans to use an MRI-guided linear accelerator to deliver the radiation treatment to ensure that the radiation dose is administered to the cancerous tumor, not the vital body organs. Potential participants with a sarcoma diagnosis will be referred to Radiation Oncology during this study. If the participant is interested in participating in this study, s/he receives radiation treatment daily for 5 consecutive days except for weekends and holidays. Within 12 weeks of completing the radiation therapy, the participant will have the primary tumor surgically removed. The radiation oncology team will follow the patients for 5 years after completing radiation therapy.

Detailed description: Each patient will undergo radiation simulation and planning. A custom vac-lok bag, alpha cradle, or equivalent immobilization device will be used. Both CT and MRI simulation will be obtained, which is standard of care for any patient undergoing radiation therapy for soft tissue sarcomas. The study investigator will be responsible for delineating the gross tumor volume (GTV) using the CT as well as MRI performed as part of staging. Guidelines for contouring will be as per the currently open NRG trial for sarcomas. In general, this may entail expansions by 5-15 mm isotropically, should include any suspicious areas be identified on T2 weighted MRI, and should be cropped to natural anatomic borders. This clinical target volume (CTV) will then be expanded to a planning treatment volume (PTV) using a 3-5 mm expansion. A prescription dose of 5-6 Gy x 5 fractions (25-30 Gy) will be delivered to at least 95% of the PTV. Stereotactic body radiotherapy (SBRT) and/or intensity modulated radiotherapy (IMRT) planning techniques may be used to minimize radiation dose to nearby organs at risk (OAR) but is not required. Delineation of normal structures will be performed and verified by the responsible study investigator. The radiation physicist or dosimetrist will optimize the treatment plan prior to approval for treatment. Dose volume histograms (DVH) and normal tissue constraint parameters specified below will be used to judge the plan quality and optimize PTV coverage with OAR sparing prior to approval. Radiation will be delivered daily for 5 consecutive days with the exception of weekends and holidays. In instances where the radiation treatment week contains a holiday or scheduling availability is limited, two fractions of radiation may be given on the same day providing that the fractions are administered ≥ 6 hours apart (this is considered standard of care treatment). Surgical resection of at least the primary tumor will follow within 12 weeks of completing radiation therapy. Surgical specimens will be sent to pathology for evaluation and for review by a multidisciplinary tumor board.

Criteria for eligibility:
Criteria:
Inclusion Criteria: - Histologically confirmed sarcoma - Primary or recurrent disease involving the abdomen or pelvis - Resectable primary lesion - Age ≥ 12 years old - Karnofsky performance status (KPS) ≥ 70 or Eastern Cooperative Oncology Group (ECOG) 0-2 - If a woman is of childbearing potential, a negative serum or urine pregnancy test must be documented Exclusion Criteria: - Active treatment of a separate malignancy - History of prior irradiation to the area targeted for treatment

Gender: All

Minimum age: 12 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: UCLA / Jonsson Comprehensive Cancer Center

Address:
City: Los Angeles
Zip: 90095
Country: United States

Status: Recruiting

Contact:
Last name: Vincent Basehart

Phone: 310-267-8954
Email: vbasehart@mednet.ucla.edu

Contact backup:
Last name: Christine Palodichuk

Phone: 3107942971
Email: cpalodichuk@mednet.ucla.edu

Investigator:
Last name: Vishruth Reddy, MD
Email: Principal Investigator

Start date: May 30, 2024

Completion date: October 26, 2025

Lead sponsor:
Agency: Jonsson Comprehensive Cancer Center
Agency class: Other

Source: Jonsson Comprehensive Cancer Center

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06436612