A Study of Radiation Therapy to Treat Solid Tumor Cancer That Has Spread to Soft Tissue

Inclusion Criteria:

• Patients with biopsy confirmed advanced/metastatic solid tumors of the followingtypes: invasive ductal or lobular breast carcinoma (all histological and intrinsicsubtypes), non-small cell lung cancer (NSCLC, all subtypes), gastrointestinalsquamous cell or adenocarcinomas (including pancreatic cancer), bladder cancer,renal cell carcinoma, melanoma, and soft tissue sarcoma (all subtypes), who requireand are being planned for palliative radiation therapy to at least one site ofRECIST-measurable extracranial metastastic disease. If a patient, requirespalliative radiotherapy to additional sites, these can be treated with standard ofcare SBRT per departmental guidelines.

• Patients with at least one additional site of RECIST-measurable extracranialmetastasis measuring at least 4 cm in one axis and suitable for elective palliativeradiation therapy. Patients should be asymptomatic or minimally symptomatic (e.gcontrolled by oral pain medications) and not in urgent need for palliation to thissite of elective experimental treatment.

• Age ≥ 18 years

• ECOG Performance Status of 0 or 1.

Exclusion Criteria:

• Patients who are pregnant or breastfeeding

• Prior radiation therapy to the candidate metastatic sites under consideration fortreatment ("re-irradiation" is disallowed).

• Medical condition such as uncontrolled infection (including HIV), uncontrolleddiabetes mellitus, or connective tissue diseases (lupus, systemic sclerosis, orother collagen vascular diseases) that, in the opinion of the treating physician,would make this protocol unreasonably hazardous for the patient.

• Patients with a "currently active" metastatic second malignancy.

• Patients on oral or parental corticosteroids. Physiological doses of steroids arepermitted (eg for patients with adrenal insufficiency). If patients are onsupraphysiological doses of steroids, these must be discontinued and held during theperiod of the study.

• Concomitant anti-neoplastic treatment is not allowed during the days of radiationtreatment delivery and should be completed or held for 3 days prior to commencementof protocol treatment and for 3 days following completion of radiotherapy, or withresolution of associated acute toxicities.

• Unwilling or unable to participate in all required study evaluations and procedures.

• Unable to understand the purpose and risks of the study and to provide a signed anddated informed consent form (ICF) and authorization to use protected healthinformation (in accordance with national and local patient privacy regulations).