Trial Comparing LATTICE Radiotherapy vs Moderately Dose-escalated Palliative Radiation for Patients With Metastases.
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age12+
SponsorStanford University
About this trial
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)
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
LATTICE Radiotherapy
Radiation5-fraction LATTICE radiotherapy delivered to 20 Gy with a simultaneous integrated boost (SIB) to 66.7 Gy.
Standard radiotherapy
RadiationStandard radiotherapy delivered to 25 Gy in 5 fractions.
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: LATTICE RadiotherapyExperimental treatment 1 intervention
Group B: Standard RadiotherapyActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Percent Tumor Volume Reduction Following Radiotherapy
Radiographic response defined as percent tumor volume reduction 90 +/- 20 days following radiotherapy
Time frame
90 +/- 20 days following radiotherapySponsors and contacts
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Source ClinicalTrials.gov