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Not yet recruiting NCT07594431

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

Phase II Interventional Metastases Metastatic Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: LATTICE Radiotherapy, Standard radiotherapy.
Who it may be relevant to
Registry conditions: Metastases, Metastatic Cancer. Basic parameters: from 12 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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)

Interventions

  • Radiation LATTICE Radiotherapy
    5-fraction LATTICE radiotherapy delivered to 20 Gy with a simultaneous integrated boost (SIB) to 66.7 Gy.
  • Radiation Standard radiotherapy
    Standard radiotherapy delivered to 25 Gy in 5 fractions.

Primary outcome measures

  • Percent Tumor Volume Reduction Following Radiotherapy [Time frame: 90 +/- 20 days following radiotherapy]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Stanford University — Palo Alto

Identifiers

NCT: NCT07594431 · IRB-86384

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗