NCT07594431

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)

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for phase_2

Timeline
24mo left

Started Aug 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 12, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 18, 2026

Completed
3 months until next milestone

Study Start

First participant enrolled

August 1, 2026

Expected
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2028

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2028

Last Updated

May 18, 2026

Status Verified

May 1, 2026

Enrollment Period

2 years

First QC Date

May 12, 2026

Last Update Submit

May 12, 2026

Conditions

Keywords

LATTICE RadiotherapyPalliative Radiotherapy

Outcome Measures

Primary Outcomes (1)

  • Percent Tumor Volume Reduction Following Radiotherapy

    Radiographic response defined as percent tumor volume reduction 90 +/- 20 days following radiotherapy

    90 +/- 20 days following radiotherapy

Study Arms (2)

LATTICE Radiotherapy

EXPERIMENTAL

Participants receive 5-fraction LATTICE radiotherapy delivered to 20 Gy with a simultaneous integrated boost (SIB) to 66.7 Gy.

Radiation: LATTICE Radiotherapy

Standard Radiotherapy

ACTIVE COMPARATOR

Participants receive standard radiotherapy (25 Gy in 5 fractions)

Radiation: Standard radiotherapy

Interventions

5-fraction LATTICE radiotherapy delivered to 20 Gy with a simultaneous integrated boost (SIB) to 66.7 Gy.

LATTICE Radiotherapy

Standard radiotherapy delivered to 25 Gy in 5 fractions.

Standard Radiotherapy

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University

Palo Alto, California, 94304, United States

Location

MeSH Terms

Conditions

Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplastic ProcessesNeoplasmsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Michael Gensheimer, MD

    Stanford University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 12, 2026

First Posted

May 18, 2026

Study Start (Estimated)

August 1, 2026

Primary Completion (Estimated)

August 1, 2028

Study Completion (Estimated)

August 1, 2028

Last Updated

May 18, 2026

Record last verified: 2026-05

Locations