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Single Versus Multifraction Salvage Spine Stereotactic Radiosurgery for Previously Irradiated Spinal Metastases

NCT03028337 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2026-03-05

No results posted yet for this study

Summary

The goal of this clinical research study is to learn whether delivering spine radiosurgery in a single large dose is better than delivering spine radiosurgery over 3 smaller doses.

Researchers also want to learn about the effects of a single dose on participant's symptoms, pain, and quality-of-life.

Conditions

  • Malignant Neoplasms of Eye Brain and Other Parts of Central Nervous System

Interventions

RADIATION

Spine Radiosurgery

Spine Radiosurgery - 1 Dose: For single fraction and multifraction arms, 0.01 cc of the cord allowed to receive 10 Gy and 14 Gy, respectively while 0.01 cc of the cauda equina allowed to receive 14 Gy and 18 Gy, respectively. Spine Radiosurgery - 3 Doses (3 days): The dose for the multifraction arm is 27 Gy in 3 fractions (9 Gy per fraction).

BEHAVIORAL

Questionnaires

Participants complete 3 questionnaires about any pain they may be having, quality-of-life, and any other symptoms. It should take about 10 minutes to complete these questionnaires. Questionnaires completed at Baseline and at Months 3,6,9,12,18, and 24 and then every 6 months after that during follow up.

Sponsors & Collaborators

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Amol J. Ghia, MD · M.D. Anderson Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-18
Primary Completion
2028-05-30
Completion
2028-05-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03028337 on ClinicalTrials.gov