Metastases, Metastatic Cancer
Conditions
Keywords
LATTICE Radiotherapy, Palliative Radiotherapy
Brief summary
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)
Interventions
5-fraction LATTICE radiotherapy delivered to 20 Gy with a simultaneous integrated boost (SIB) to 66.7 Gy.
Standard radiotherapy delivered to 25 Gy in 5 fractions.
Sponsors
Study design
Eligibility
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Tumor Volume Reduction Following Radiotherapy | 90 +/- 20 days following radiotherapy | Radiographic response defined as percent tumor volume reduction 90 +/- 20 days following radiotherapy |
Countries
United States
Contacts
Stanford University