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Phase II/III Study of Image-Guided Radiosurgery/SBRT for Localized Spine Metastasis

ClinicalTrials.gov · COMPLETED, 2020

399 participants

Abstract

RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue.

PURPOSE: This randomized phase II/III trial is studying how well image-guided radiosurgery or stereotactic body radiation therapy works and compares it to external-beam radiation therapy in treating patients with localized spine metastasis.

Conditions: Metastatic Cancer, Pain.

Primary outcome: Percentage of Patients Receiving Radiosurgery/SBRT Per Protocol or With Minor Variation (Phase II); Percentage of Patients With Complete or Partial Pain Response at 3 Months (Phase III).

Enrollment: 399 participants.

How strong is the evidence?

Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 399 participants or records.

How the five levels of evidence work. The level is assigned automatically from the abstract and can be wrong, so check the paper.

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