Adaptive Stereotactic Body Radiation Therapy for the Treatment of Abdominal and Pelvic Metastases, ARAM Trial

Inclusion Criteria

• 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, IR techniques, or 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 ≥ 10mm. Previous systemic therapies are allowed
• Age >= 18 years
• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
• Estimated survival of >/= 12 months
• Absolute neutrophil count >= 1,000/mcL
• Platelets >= 75,000/mcL
• Total bilirubin < 3 mg/dL
• Subjects must possess the ability to understand and willingness to sign a written informed consent and Health Insurance Portability and Accountability Act (HIPAA) consent document. Translation services including translation of informed consent documents will be provided, as feasible, to encourage diversity of inclusion of eligible patients

Exclusion Criteria

• Subjects who have had chemotherapy or radiotherapy within 2 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 2 weeks earlier to < grade 2. Patients who received previous immunotherapy or other antibody therapy, within 28 days (immune related toxicities must have resolved to =< grade 2 prior to starting treatment). Study treatment may be started within these washout periods or with continuing toxicities if considered by the Sponsor- Investigator to be safe and within the best interest of the patient.
• Subjects must not be receiving any other investigational agents
• Subjects should not have any visible peritoneal carcinomatosis on imaging tests
• Subjects should not have any known active (untreated with local therapy- radiation or IR) solid tumors outside of the abdomen/pelvis. * A subject with an untreated tumor that is not a part of study treatment is ineligible * Imaging scans outside of the abdomen/pelvis may be performed based on physician discretion
• Subjects must not have 6 or more active metastatic sites
• Subjects have had prior radiotherapy to any target metastatic lesion. Prior radiotherapy to non-target sites is allowed
• 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)
• Subjects must not be pregnant or breast-feeding