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

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ClinicalTrials.gov Identifier: NCT00080912
Recruitment Status : Completed
First Posted : April 8, 2004
Results First Posted : February 26, 2015
Last Update Posted : April 14, 2020
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Radiation Therapy Oncology Group
Trans Tasman Radiation Oncology Group
Cancer Research UK
Assistance Publique - Hôpitaux de Paris
Information provided by (Responsible Party):
Canadian Cancer Trials Group ( NCIC Clinical Trials Group )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Metastatic Cancer
Pain
Intervention Radiation: radiation therapy
Enrollment 850
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Single-fraction Multiple-fraction
Hide Arm/Group Description

Patients receive single-fraction radiotherapy (8 Gy) on day 1.

radiation therapy: Given in a single fraction or multiple fractions

Patients receive multiple-fraction radiotherapy (to a total of 20 Gy) over 5 days or over 8 days if re-irradiation of the spine and/or whole pelvis is involved AND prior initial radiotherapy was given in multiple fractions.

radiation therapy: Given in a single fraction or multiple fractions

Period Title: Overall Study
Started 425 425
Completed 425 425
Not Completed 0 0
Arm/Group Title Single-fraction Multiple-fraction Total
Hide Arm/Group Description

Patients receive single-fraction radiotherapy (8 Gy) on day 1.

radiation therapy: Given in a single fraction or multiple fractions

Patients receive multiple-fraction radiotherapy (to a total of 20 Gy) over 5 days or over 8 days if re-irradiation of the spine and/or whole pelvis is involved AND prior initial radiotherapy was given in multiple fractions.

radiation therapy: Given in a single fraction or multiple fractions

Total of all reporting groups
Overall Number of Baseline Participants 425 425 850
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 425 participants 425 participants 850 participants
64.6
(18.4 to 94.5)
65.3
(32.0 to 93.0)
65.1
(18.4 to 94.5)
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 424 participants 423 participants 847 participants
Female
181
  42.7%
167
  39.5%
348
  41.1%
Male
243
  57.3%
256
  60.5%
499
  58.9%
[1]
Measure Analysis Population Description: One patient in the single-fraction arm and two patients in the multiple fractions arm have missing sex information.
1.Primary Outcome
Title Pain Relief Measured by the Brief Pain Inventory at 2 Months After Treatment
Hide Description 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%.
Time Frame 2 months
Hide Outcome Measure Data
Hide Analysis Population Description
Intend to treat (ITT) population
Arm/Group Title Single-fraction Multiple-fraction
Hide Arm/Group Description:

Patients receive single-fraction radiotherapy (8 Gy) on day 1.

radiation therapy: Given in a single fraction or multiple fractions

Patients receive multiple-fraction radiotherapy (to a total of 20 Gy) over 5 days or over 8 days if re-irradiation of the spine and/or whole pelvis is involved AND prior initial radiotherapy was given in multiple fractions.

radiation therapy: Given in a single fraction or multiple fractions

Overall Number of Participants Analyzed 425 425
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
28.0
(24.0 to 32.0)
32.0
(27.0 to 36.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Single-fraction, Multiple-fraction
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence (legacy)
Comments The original sample size was determined based on the non-inferiority. The original sample size is based on assumption of response rate on the multiple fraction arm is 70%, 260 patients were required in each treatment arm to have 80% power to exclude, with a one sided alpha of 0.05, a response rate of 60% or less in the single fraction radiation group (non-inferiority margin =10%). Given an inevaluability rate of 30%, 850 patients (425 for each treatment arm) were randomized to the study.
Statistical Test of Hypothesis P-Value 0.03
Comments p-value is for one-sided non-inferiority test
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 4.0
Confidence Interval (1-Sided) 95%
9.2
Estimation Comments The upper limit of one-sided 95% CI for the response rate difference was 9.2%, which was below the pre-specified 10% non-inferiority boundary
Time Frame 8.2 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Single-fraction Multiple-fraction
Hide Arm/Group Description

Patients receive single-fraction radiotherapy (8 Gy) on day 1.

radiation therapy: Given in a single fraction or multiple fractions

Patients receive multiple-fraction radiotherapy (to a total of 20 Gy) over 5 days or over 8 days if re-irradiation of the spine and/or whole pelvis is involved AND prior initial radiotherapy was given in multiple fractions.

radiation therapy: Given in a single fraction or multiple fractions

All-Cause Mortality
Single-fraction Multiple-fraction
Affected / at Risk (%) Affected / at Risk (%)
Total   227/425 (53.41%)   220/425 (51.76%) 
Hide Serious Adverse Events
Single-fraction Multiple-fraction
Affected / at Risk (%) Affected / at Risk (%)
Total   1/425 (0.24%)   0/425 (0.00%) 
Cardiac disorders     
Cardiac ischemia/infarction   1/425 (0.24%)  0/425 (0.00%) 
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Single-fraction Multiple-fraction
Affected / at Risk (%) Affected / at Risk (%)
Total   0/425 (0.00%)   0/425 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Bingshu Chen
Organization: NCIC Clinical Trials Group
Phone: 613-533-6000 ext 77703
EMail: bechen@ctg.queensu.ca
Layout table for additonal information
Responsible Party: Canadian Cancer Trials Group ( NCIC Clinical Trials Group )
ClinicalTrials.gov Identifier: NCT00080912    
Obsolete Identifiers: NCT00797173
Other Study ID Numbers: SC20
CAN-NCIC-SC20 ( Other Identifier: PDQ )
RTOG-0433 ( Other Identifier: RTOG )
TROG-03.08 ( Other Identifier: TROG )
CDR0000357423 ( Other Identifier: PDQ )
First Submitted: April 7, 2004
First Posted: April 8, 2004
Results First Submitted: February 11, 2015
Results First Posted: February 26, 2015
Last Update Posted: April 14, 2020