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

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

  • Metastases
  • Metastatic Cancer

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