CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 850 enrolled
Drug / intervention
radiation therapyradiation
Likely dose
Single fraction or multiple fractions (specific dose not specified in record)AI-extracted
Key inclusion· 7
  • Histologically or cytologically confirmed malignancy
  • Painful bone metastases confirmed by imaging (X-ray, bone scan, CT, or MRI)
  • Baseline pain score ≥2/10 on Brief Pain Inventory
  • Pain from previously irradiated metastases, not from new/progressive disease elsewhere
Key exclusion· 8
  • Clinical or radiological evidence of pathological fractures at target site
  • High-risk lytic lesions (>3 cm or >50% cortical erosion) in extremities if patient is surgical candidate
  • Clinical or radiological evidence of spinal cord compression at target site
  • More than 1 prior course of radiotherapy to target site

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

Search/NCT00080912
NCT00080912N/ACompleted

A Phase III International Randomized Trial Of Single Versus Multiple Fractions For Re-Irradiation Of Painful Bone Metastases

NCIC Clinical Trials Group·interventional·Posted Apr 8, 2004·Updated Aug 21, 2023

In Brief

A clinical study evaluating radiation therapy for Metastatic Cancer and Pain. Completed, enrolled 850 participants across 12 sites.

Detailed Summary

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known whether single-fraction (single-dose) re-irradiation therapy is as effective as multiple-fraction (many small doses of radiation therapy) re-irradiation therapy in relieving bone pain caused by bone metastases. PURPOSE: This randomized phase III trial is studying single-dose radiation therapy to see if it works as well as multiple-dose radiation therapy in treating patients previously irradiated with painful bone metastases.

Study Details

Timeline

N/ACompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 8, 2004
Enrollment StartJan 22, 2004
Primary CompletionApr 10, 2013
Study CompletionJan 16, 2014
TodayJul 2, 2026
Enrollment to primary: 9.2 yearsPosted 22.2 years ago

Interventions

radiation therapyradiation

Given in a single fraction or multiple fractions