Trial Comparing LATTICE Radiotherapy vs Moderately Dose-escalated Palliative Radiation for Patients With Metastases.

A Randomized Phase II Trial Comparing LATTICE Radiotherapy vs Moderately Dose-escalated Palliative Radiation for Patients With Metastases.

Unblinded, randomized study of 5-fraction LATTICE radiotherapy (20 Gy with an SIB to 66.7 Gy in 5 fractions) versus moderately dose-escalated palliative radiation (25 Gy in 5 fractions)

80 patients with confirmed metastatic tumor (>2.5 cm in short axis) will be enrolled, all ≥ 12 years of age with ECOG ≤ 2. All genders and races will be included.

Inclusion Criteria:

• Histologically, cytologically, or radiographically confirmed diagnosis of metastatic cancer
• One to two metastases in non-brain sites that are amenable to LATTICE radiotherapy: >2.5 cm in short axis (dimension on axial imaging that is perpendicular to the longest dimension); bone metastasis can be included if the extraosseous component is >2.5 cm in short axis
• Age ≥12
• ECOG Performance Status 0-2
• For patients age 12-16, Lansky Play-Performance score 50-100
• Negative serum or urine pregnancy test within 2 weeks prior to enrollment of people of childbearing potential
• All patients and/or their parents or legal guardians must sign a written informed consent. For any child less than 18 years of age, assent must also be obtained in addition to parental or legal guardian consent.

Exclusion criteria:

• Prior radiation therapy to the tumor to be treated
• Active pregnancy
• Diseases that place the patient at high risk of radiation complications including lupus, scleroderma, Li Fraumeni syndrome
• The tumor to be treated is from a hematologic malignancy such as lymphoma or myeloma