## Protocol Section
### Identification Module
**NCT ID:** NCT06436612

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

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

#### Organization Study ID Info
**ID:** 23-001583
#### Organization
**Class:** OTHER
**Full Name:** Jonsson Comprehensive Cancer Center
#### Secondary ID Infos
**Domain:** Clinical Trials Reporting Program
**ID:** NCI-2024-04364
**Type:** REGISTRY
### Status Module
#### Completion Date
**Date:** 2025-10-26

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31

**Type:** ESTIMATED

**Last Update Submit Date:** 2024-05-28

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2024-10-26

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-20

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-31
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-14
**Study First Submit QC Date:** 2024-05-28
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Jonsson Comprehensive Cancer Center

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** True

**Is FDA Regulated Drug:** False

**Is US Export:** False

### Description Module

**Brief 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.

### Conditions Module

**Conditions:**

- Abdominopelvic Sarcomas

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 20

**Type:** ESTIMATED

**Phases:**

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** MRI or CT-guided SBRT will be delivered in the pre-operative setting. Patients will receive 5.0-6.0 Gy x 5 fractions delivered daily.

**Intervention Names:**

- Radiation: Magnetic Resonance Image and Computed Tomography-Guided Stereotactic Body Radiation Therapy

**Label:** Arm I

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Arm I

**Description:** stereotactic body radiation therapy (SBRT) administered over 5 days x 5.0 - 6.0 Gy for patients with abdominopelvic sarcomas.

**Name:** Magnetic Resonance Image and Computed Tomography-Guided Stereotactic Body Radiation Therapy

**Other Names:**

- Pre-operative stereotactic body radiation therapy (SBRT)

**Type:** RADIATION

### Outcomes Module

#### Primary Outcomes

**Description:** Evaluate the 2 year rate of grade ≥2 radiation morbidity, according to Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.

**Measure:** Radiation morbidity at 2 years

**Time Frame:** At 2 years

#### Secondary Outcomes

**Description:** Defined as freedom from radiographic progression of the treated site. It will be evaluated using CT and/or MRI of the abdomen and pelvis.

**Measure:** Local Control

**Time Frame:** At 2 years

**Description:** Defined as freedom from radiographic progression in the abdomen or pelvis outside of the treated site. It will be evaluated using CT and/or MRI of the abdomen and pelvis.

**Measure:** Regional Control

**Time Frame:** At 2 years

**Measure:** Distant metastasis

**Time Frame:** At 2 years

**Measure:** Progression free survival

**Time Frame:** At 2 years

**Measure:** Overall survival

**Time Frame:** At 2 years

### Eligibility Module

**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

**Minimum Age:** 12 Years

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** cpalodichuk@mednet.ucla.edu

**Name:** Christy Palodichuk

**Phone:** 3107942971

**Role:** CONTACT

**Contact 2:**

**Email:** vbasehart@mednet.ucla.edu

**Name:** Vincent Basehart

**Phone:** 3102678954

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Los Angeles

**Contacts:**

***Contact 1:***

- **Email:** vbasehart@mednet.ucla.edu

- **Name:** Vincent Basehart

- **Phone:** 310-267-8954

- **Role:** CONTACT

***Contact 2:***

- **Email:** cpalodichuk@mednet.ucla.edu

- **Name:** Christine Palodichuk

- **Phone:** 3107942971

- **Role:** CONTACT

***Contact 3:***

- **Name:** Vishruth Reddy, MD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** United States

**Facility:** UCLA / Jonsson Comprehensive Cancer Center

**State:** California

**Zip:** 90095

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000018204

- Term: Neoplasms, Connective and Soft Tissue

- ID: D000009370

- Term: Neoplasms by Histologic Type

- ID: D000009369

- Term: Neoplasms

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: All

- Name: All Conditions

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M15327

- Name: Sarcoma

- Relevance: HIGH

- As Found: Sarcoma

- ID: M20350

- Name: Neoplasms, Connective and Soft Tissue

- Relevance: LOW

- As Found: Unknown

- ID: M12315

- Name: Neoplasms by Histologic Type

- Relevance: LOW

- As Found: Unknown

- ID: T5284

- Name: Soft Tissue Sarcoma

- Relevance: HIGH

- As Found: Sarcoma

### Condition Browse Module - Meshes

- ID: D000012509

- Term: Sarcoma

### Misc Info Module

- Version Holder: 2024-05-31
