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

May 12, 2026 updated by: Stanford University

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

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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • Palo Alto, California, United States, 94304
        • Stanford University
        • Contact:
        • Contact:
        • Principal Investigator:
          • Michael Gensheimer, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent Tumor Volume Reduction Following Radiotherapy
Time Frame: 90 +/- 20 days following radiotherapy
Radiographic response defined as percent tumor volume reduction 90 +/- 20 days following radiotherapy
90 +/- 20 days following radiotherapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Investigators

  • Principal Investigator: Michael Gensheimer, MD, Stanford University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2026

Primary Completion (Estimated)

August 1, 2028

Study Completion (Estimated)

August 1, 2028

Study Registration Dates

First Submitted

May 12, 2026

First Submitted That Met QC Criteria

May 12, 2026

First Posted (Actual)

May 18, 2026

Study Record Updates

Last Update Posted (Actual)

May 18, 2026

Last Update Submitted That Met QC Criteria

May 12, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-86384

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Metastatic Cancer

Clinical Trials on LATTICE Radiotherapy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Pakistan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe