NCT07594431RecruitingPhase 2
A Randomized Phase II Trial Comparing LATTICE Radiotherapy vs Moderately Dose-escalated Palliative Radiation for Patients With Metastases.
Interventions
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- Stanford University
- Enrollment
- 80
- Locations
- 2
Study Overview
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)
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 12 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •80 patients with confirmed metastatic tumor (>2.5 cm in short axis) will be enrolled, all ≥ 12 years of age with ECOG ≤
- •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
- •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
Arms & Interventions
LATTICE Radiotherapy
Experimental
Participants receive 5-fraction LATTICE radiotherapy delivered to 20 Gy with a simultaneous integrated boost (SIB) to 66.7 Gy.
Intervention: LATTICE Radiotherapy (Radiation)
Standard Radiotherapy
Active Comparator
Participants receive standard radiotherapy (25 Gy in 5 fractions)
Intervention: Standard radiotherapy (Radiation)
Investigators
Study Sites (2)
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