CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 399 enrolled
Drug / intervention
External beam radiation therapy +1 moreradiation
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00922974
NCT00922974Phase 3Completed
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Phase II/III Study of Image-Guided Radiosurgery/SBRT for Localized Spine Metastasis

Radiation Therapy Oncology Group·interventional·Posted Jun 18, 2009·Updated Apr 29, 2025

In Brief

A Phase 3 clinical trial evaluating External beam radiation therapy and Radiosurgery/SBRT for Metastatic Cancer and Pain. Completed, enrolled 399 participants across 38 sites in 3 countries.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMetastatic Cancer, Pain
CountriesCanada, Israel, United States
CollaboratorsNational Cancer Institute (NCI), NRG Oncology

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedJun 18, 2009
Enrollment StartNov 1, 2009
Primary CompletionJan 1, 2018
Study CompletionApr 6, 2020
TodayJul 2, 2026
Enrollment to primary: 8.2 yearsPosted 17.0 years ago

Interventions

External beam radiation therapyradiation

Single fraction dose of 8 Gy external beam radiation therapy

Radiosurgery/SBRTradiation

Single fraction dose image-guided radiosurgery / stereotactic body radiotherapy (SBRT). The phase II component uses 16 Gy. The phase III component allows 16 or 18 Gy as preferred by the treating physician.