NCT00080912

Single vs Multiple-Fraction Therapy in Treating Patients With Previously Irradiated Painful Bone Metastases

Completed NA Results posted Last updated 21 August 2023

What this trial tests

NA trial testing radiation therapy in Metastatic Cancer in 850 participants. Completed in 16 January 2014.

Timeline

22 January 2004

Primary endpoint
10 April 2013

16 January 2014

Quick facts

Lead sponsor	NCIC Clinical Trials Group
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	850
Start date	22 January 2004
Primary completion	10 April 2013
Estimated completion	16 January 2014
Sites	12 locations across Canada

Drugs / interventions tested

• radiation therapy — full drug profile →

Conditions studied

• Metastatic Cancer — all drugs for Metastatic Cancer →
• Pain — all drugs for Pain →

Sponsor

NCIC Clinical Trials Group

Who can join

18 and older, any sex, with Metastatic Cancer or Pain. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Pain Relief Measured by the Brief Pain Inventory at 2 Months After Treatment Primary · 2 months

The primary endpoint of this study is Overall Response Rate (complete response and partial response) at two months after the first fraction of re-irradiation. A complete response was defined as a Brief Pain Inventory worst-pain score of zero with no associated increase in daily oral morphine equivalent. A partial response was defined as pain that persisted after treatment, either with a worst-pain score reduction of 2 or more and no increase in daily oral morphine equivalent consumption, or no increase in pain and a reduction in daily oral morphine equivalent consumption of at least 25%.

Group	Value	95% CI
Single-fraction	28.0	24.0 – 32.0
Multiple-fraction	32.0	27.0 – 36.0

Adverse events — posted to ClinicalTrials.gov

Time frame: 8.2 years. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Single-fraction

Serious: 1/425 (0%)

Deaths: 227/425

Multiple-fraction

Serious: 0/425 (0%)

Deaths: 220/425

Serious adverse events (1 terms)

Reaction	System	Single-fraction	Multiple-fraction
Cardiac ischemia/infarction	Cardiac disorders	—	—

Most-reported serious reactions: Cardiac ischemia/infarction.

Data from ClinicalTrials.gov NCT00080912 adverse events section.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Single versus multiple fractions of repeat radiation for painful bone metastases: a randomised, controlled, non-inferiority trial.
   Chow E, van der Linden YM, Roos D, Hartsell WF, et al · · 2014 · cited 175× · PMID 24369114 · DOI 10.1016/s1470-2045(13)70556-4
2. Impact of reirradiation of painful osseous metastases on quality of life and function: a secondary analysis of the NCIC CTG SC.20 randomized trial.
   Chow E, Meyer RM, Chen BE, van der Linden YM, et al · · 2014 · cited 21× · PMID 25349296 · DOI 10.1200/jco.2014.57.6264
3. 2020 Korean guidelines for the management of metastatic prostate cancer.
   Kim IH, Shin SJ, Kang BW, Kang J, et al · · 2021 · cited 6× · PMID 33561334 · DOI 10.3904/kjim.2020.213
4. Gender and age make no difference in the re-irradiation of painful bone metastases: A secondary analysis of the NCIC CTG SC.20 randomized trial.
   Chow R, Ding K, Ganesh V, Meyer RM, et al · · 2018 · cited 3× · PMID 29102263 · DOI 10.1016/j.radonc.2017.10.006