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Purpose

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)

Conditions

Eligibility

Eligible Ages
Over 12 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
LATTICE Radiotherapy 		Participants receive 5-fraction LATTICE radiotherapy delivered to 20 Gy with a simultaneous integrated boost (SIB) to 66.7 Gy.
  • Radiation: LATTICE Radiotherapy
    5-fraction LATTICE radiotherapy delivered to 20 Gy with a simultaneous integrated boost (SIB) to 66.7 Gy.
Active Comparator
Standard Radiotherapy 		Participants receive standard radiotherapy (25 Gy in 5 fractions)
  • Radiation: Standard radiotherapy
    Standard radiotherapy delivered to 25 Gy in 5 fractions.

Recruiting Locations

Stanford University
Palo Alto, California 94304
Contact:
Jamie Wong
650-497-4354
jwang97@stanford.edu

More Details

Status
Recruiting
Sponsor
Stanford University

Study Contact

Jamie Wang
650-497-4354
jwang97@stanford.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.