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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age12+
SponsorJonsson Comprehensive Cancer Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Histologically confirmed sarcoma

Primary or recurrent disease involving the abdomen or pelvis

Resectable primary lesion

Age ≥ 12 years old

Disqualifiers

Active treatment of a separate malignancy

History of prior irradiation to the area targeted for treatment

Trial design

Design model

Single group

Treatments tested in this trial

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

    Radiation

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

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Arm IExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Radiation morbidity at 2 years

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

Time frame
At 2 years

Secondary outcomes

1

Local Control

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

Time frame
At 2 years
2

Regional Control

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.

Time frame
At 2 years
3

Distant metastasis

Time frame
At 2 years
4

Progression free survival

Time frame
At 2 years

Other outcomes

Sponsors and contacts

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