LATTICE radiotherapy vs moderately dose-escalated palliative radiation for metastases

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In this unblinded, randomized phase 2 trial, patients with metastatic cancer receive either 20 Gy of LATTICE radiotherapy with a high-dose boost to 66.7 Gy in 5 fractions or 25 Gy in 5 fractions of moderately escalated palliative radiotherapy. Eligible participants have 1–2 non-brain metastases larger than 2.5 cm, are 12 years or older, and have an ECOG score of 0–2. The study aims to compare local control and safety between the two regimens, enrolling up to 80 participants at a single site. Lead sponsorship is provided by Stanford University.

Why it matters

Who can join: the full rules

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

Where it's running

• Stanford University
  Palo Alto, California, United States Recruiting

Study contacts

• Principal investigator: Michael Gensheimer, MD — Stanford University
• Study coordinator: Jamie Wang
• Email: jwang97@stanford.edu
• Phone: 650-497-4354

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.