Trial Outcomes & Findings for Single vs Multiple-Fraction Therapy in Treating Patients With Previously Irradiated Painful Bone Metastases (NCT NCT00080912)

Results Overview

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%.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

850 participants

Primary outcome timeframe

2 months

Results posted on

2023-08-21

Participant Flow

Participant milestones

Participant milestones
Measure	Single-fraction Patients receive single-fraction radiotherapy (8 Gy) on day 1. radiation therapy: Given in a single fraction or multiple fractions	Multiple-fraction 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 Study STARTED	425	425
Overall Study COMPLETED	425	425
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

One patient in the single-fraction arm and two patients in the multiple fractions arm have missing sex information.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Single-fraction n=425 Participants Patients receive single-fraction radiotherapy (8 Gy) on day 1. radiation therapy: Given in a single fraction or multiple fractions	Multiple-fraction n=425 Participants 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 n=850 Participants Total of all reporting groups
Age, Continuous	64.6 years n=425 Participants	65.3 years n=425 Participants	65.1 years n=850 Participants
Sex: Female, Male Female	181 Participants n=424 Participants • One patient in the single-fraction arm and two patients in the multiple fractions arm have missing sex information.	167 Participants n=423 Participants • One patient in the single-fraction arm and two patients in the multiple fractions arm have missing sex information.	348 Participants n=847 Participants • One patient in the single-fraction arm and two patients in the multiple fractions arm have missing sex information.
Sex: Female, Male Male	243 Participants n=424 Participants • One patient in the single-fraction arm and two patients in the multiple fractions arm have missing sex information.	256 Participants n=423 Participants • One patient in the single-fraction arm and two patients in the multiple fractions arm have missing sex information.	499 Participants n=847 Participants • One patient in the single-fraction arm and two patients in the multiple fractions arm have missing sex information.

PRIMARY outcome

Timeframe: 2 months

Population: Intend to treat (ITT) population

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%.

Outcome measures

Outcome measures
Measure	Single-fraction n=425 Participants Patients receive single-fraction radiotherapy (8 Gy) on day 1. radiation therapy: Given in a single fraction or multiple fractions	Multiple-fraction n=425 Participants 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
Pain Relief Measured by the Brief Pain Inventory at 2 Months After Treatment	28.0 percentage of participants Interval 24.0 to 32.0	32.0 percentage of participants Interval 27.0 to 36.0

Adverse Events

Single-fraction

Serious events: 1 serious events

Other events: 0 other events

Deaths: 227 deaths

Multiple-fraction

Serious events: 0 serious events

Other events: 0 other events

Deaths: 220 deaths

Serious adverse events

Serious adverse events
Measure	Single-fraction n=425 participants at risk Patients receive single-fraction radiotherapy (8 Gy) on day 1. radiation therapy: Given in a single fraction or multiple fractions	Multiple-fraction n=425 participants at risk 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
Cardiac disorders Cardiac ischemia/infarction	0.24% 1/425 • 8.2 years	0.00% 0/425 • 8.2 years

Other adverse events

Adverse event data not reported

Additional Information

Dr. Bingshu Chen

NCIC Clinical Trials Group

Phone: 613-533-6000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place