Study Summary
Recent advancements in radiation technology permit daily adjustment of the radiation plan to account for changes in position of the organs in your abdomen and pelvis and variations in the surrounding normal tissues. This means a new radiation plan can be created for every treatment visit based on what your anatomy looks like that day. This approach is known as “adaptive SBRT”. By using adaptive SBRT, it may be possible to shape the radiation more tightly to the location of your tumors and lower the radiation dose to the surrounding normal tissues. The safety of different doses of radiation will be evaluated to help determine the safest dose for future patients.

This study is being conducted to evaluate whether adaptive SBRT reduces the severity of symptoms that may arise from your radiation treatment. The radiation treatment machine used in this study to deliver adaptive SBRT (Ethos Radiotherapy System) is approved for routine clinical use. You may be able to receive adaptive SBRT without participating in this study. Approximately 30 patients will take part in this single-center study.

The study simulation and treatment will be performed over 3-4 weeks. The follow-up portion of the study will be 3 months up to 2 years.

Protocol: 23-1012 / IRB23-1012
Phase: I
Investigator: Joshua Meyer, MD
Disease(s): Other Digestive Organ
Full Title: RT-218: Adaptive Radiation for Abdominopelvic Metastases (ARAM)

ClinicalTrials.gov
Visit ClinicalTrials.gov for a full clinical trial description.

Eligibility
To be eligible for this study, patients must meet several criteria, including but not limited to the following:

• Subjects must have histologically or cytologically confirmed cancer that is metastatic (all solid tumor types accepted), with at least one target lesion untreated by radiation, or IR techniques, and growing in the abdomen or pelvis. Adjacent lymph nodes in the same region (5 cm or closer) constitute one active lesion. Target lesion must be measurable according to RECIST v 1.1. Previous systemic therapies are allowed.
• Age > 18 years
• ECOG performance status 0 or 1
• Estimated survival of >/= 12 months
• Subjects must not be experiencing toxicity due to prior therapy that has not resolved to ?Grade 1 by study registration, with the exception of sensory neuropathy related to previous systemic therapy exposure, alopecia, and fatigue.
• Subjects must not have known active solid tumors on imaging outside of abdomen/pelvis noted on screening imaging.
• Subjects must not have uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
• Any condition or significant co-morbidity that prevents safe delivery of SBRT per the discretion of the treating physician(s).

For more information about this and other studies and to inquire about eligibility, please call 215-214-1515.