Trial Outcomes & Findings for Study Comparing Stereotactic Body Radiotherapy vs Conventional Palliative Radiotherapy (CRT) for Spinal Metastases (NCT NCT02512965)

Last Updated: 2024-02-13

Results Overview

A Complete Pain Response is defined as a pain score of zero (0) at the treated site with no concomitant increase in analgesic intake (stable or reducing analgesics in daily oral morphine equivalent) .

Recruitment status

COMPLETED

Study phase

Target enrollment

229 participants

Primary outcome timeframe

3 months

Results posted on

2024-02-13

Participant Flow

Participant milestones

Participant milestones
Measure	Standard Conventional Radiotherapy Standard Conventional Radiotherapy (CRT) 20 Gy in 5 fractions 20 Gy in 5 fractions	Stereotactic Body Radiotherapy Stereotactic Body Radiotherapy (SBRT) 24 Gy in 2 fractions Conventional SBRT: 24 Gy in 2 fractions
Overall Study STARTED	115	114
Overall Study COMPLETED	115	110
Overall Study NOT COMPLETED	0	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Standard Conventional Radiotherapy Standard Conventional Radiotherapy (CRT) 20 Gy in 5 fractions 20 Gy in 5 fractions	Stereotactic Body Radiotherapy Stereotactic Body Radiotherapy (SBRT) 24 Gy in 2 fractions Conventional SBRT: 24 Gy in 2 fractions
Overall Study Withdrawal by Subject	0	4

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Standard Conventional Radiotherapy n=115 Participants Standard Conventional Radiotherapy (CRT) 20 Gy in 5 fractions 20 Gy in 5 fractions	Stereotactic Body Radiotherapy n=114 Participants Stereotactic Body Radiotherapy (SBRT) 24 Gy in 2 fractions Conventional SBRT: 24 Gy in 2 fractions	Total n=229 Participants Total of all reporting groups
Age, Continuous	64.05 years STANDARD_DEVIATION 12.7 • n=115 Participants	63.67 years STANDARD_DEVIATION 12.1 • n=114 Participants	63.86 years STANDARD_DEVIATION 12.38 • n=229 Participants
Sex: Female, Male Female	54 Participants n=115 Participants	55 Participants n=114 Participants	109 Participants n=229 Participants
Sex: Female, Male Male	61 Participants n=115 Participants	59 Participants n=114 Participants	120 Participants n=229 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Canada	103 participants n=115 Participants	102 participants n=114 Participants	205 participants n=229 Participants
Region of Enrollment Australia	12 participants n=115 Participants	12 participants n=114 Participants	24 participants n=229 Participants
ECOG Performance Status 0	14 Participants n=115 Participants	16 Participants n=114 Participants	30 Participants n=229 Participants
ECOG Performance Status 1	90 Participants n=115 Participants	90 Participants n=114 Participants	180 Participants n=229 Participants
ECOG Performance Status 2	11 Participants n=115 Participants	8 Participants n=114 Participants	19 Participants n=229 Participants
Worst pain score 2	11 Participants n=115 Participants	12 Participants n=114 Participants	23 Participants n=229 Participants
Worst pain score 3	14 Participants n=115 Participants	19 Participants n=114 Participants	33 Participants n=229 Participants
Worst pain score 4	18 Participants n=115 Participants	15 Participants n=114 Participants	33 Participants n=229 Participants
Worst pain score 5	16 Participants n=115 Participants	18 Participants n=114 Participants	34 Participants n=229 Participants
Worst pain score 6	12 Participants n=115 Participants	14 Participants n=114 Participants	26 Participants n=229 Participants
Worst pain score 7	17 Participants n=115 Participants	10 Participants n=114 Participants	27 Participants n=229 Participants
Worst pain score 8	12 Participants n=115 Participants	11 Participants n=114 Participants	23 Participants n=229 Participants
Worst pain score 9	10 Participants n=115 Participants	5 Participants n=114 Participants	15 Participants n=229 Participants
Worst pain score 10	5 Participants n=115 Participants	10 Participants n=114 Participants	15 Participants n=229 Participants
Spinal instability neoplastic score (SINS) 0-6	46 Participants n=115 Participants	57 Participants n=114 Participants	103 Participants n=229 Participants
Spinal instability neoplastic score (SINS) > 6	69 Participants n=115 Participants	57 Participants n=114 Participants	126 Participants n=229 Participants
Histology Radioresistant	30 Participants n=115 Participants	30 Participants n=114 Participants	60 Participants n=229 Participants
Histology Radiosensitive	85 Participants n=115 Participants	84 Participants n=114 Participants	169 Participants n=229 Participants
Mass on imaging Absent	43 Participants n=115 Participants	41 Participants n=114 Participants	84 Participants n=229 Participants
Mass on imaging Present	72 Participants n=115 Participants	73 Participants n=114 Participants	145 Participants n=229 Participants

PRIMARY outcome

Timeframe: 3 months

Population: ITT population

Outcome measures

Outcome measures
Measure	Standard Conventional Radiotherapy n=115 Participants Standard Conventional Radiotherapy (CRT) 20 Gy in 5 fractions 20 Gy in 5 fractions	Stereotactic Body Radiotherapy n=114 Participants Stereotactic Body Radiotherapy (SBRT) 24 Gy in 2 fractions Conventional SBRT: 24 Gy in 2 fractions
Phase III: Complete Pain Response at 3 Months Post-radiation CR	16 Participants	40 Participants
Phase III: Complete Pain Response at 3 Months Post-radiation PR	29 Participants	20 Participants
Phase III: Complete Pain Response at 3 Months Post-radiation SD	34 Participants	27 Participants
Phase III: Complete Pain Response at 3 Months Post-radiation PD	14 Participants	7 Participants
Phase III: Complete Pain Response at 3 Months Post-radiation In-evalable	22 Participants	16 Participants

SECONDARY outcome

Timeframe: 6 months post radiation

Population: ITT population

Outcome measures

Outcome measures
Measure	Standard Conventional Radiotherapy n=115 Participants Standard Conventional Radiotherapy (CRT) 20 Gy in 5 fractions 20 Gy in 5 fractions	Stereotactic Body Radiotherapy n=114 Participants Stereotactic Body Radiotherapy (SBRT) 24 Gy in 2 fractions Conventional SBRT: 24 Gy in 2 fractions
Complete Pain Response at 6 Months Post Radiation Based on the International Bone Metastases Consensus Working Party Criteria CR	18 Participants	37 Participants
Complete Pain Response at 6 Months Post Radiation Based on the International Bone Metastases Consensus Working Party Criteria PR	18 Participants	10 Participants
Complete Pain Response at 6 Months Post Radiation Based on the International Bone Metastases Consensus Working Party Criteria SD	32 Participants	26 Participants
Complete Pain Response at 6 Months Post Radiation Based on the International Bone Metastases Consensus Working Party Criteria PD	8 Participants	5 Participants
Complete Pain Response at 6 Months Post Radiation Based on the International Bone Metastases Consensus Working Party Criteria In-evaluable	39 Participants	36 Participants

SECONDARY outcome

Timeframe: 6 months.

Population: ITT population

Radiation site progression was defined as: * Gross unequivocal increase in tumor volume or linear dimension \> 20%. * Any new or progressive tumor within the epidural space. * Neurologic deterioration attributable to pre-existing epidural disease with equivocal increased epidural disease dimensions on MRI.

Outcome measures

Outcome measures
Measure	Standard Conventional Radiotherapy n=115 Participants Standard Conventional Radiotherapy (CRT) 20 Gy in 5 fractions 20 Gy in 5 fractions	Stereotactic Body Radiotherapy n=114 Participants Stereotactic Body Radiotherapy (SBRT) 24 Gy in 2 fractions Conventional SBRT: 24 Gy in 2 fractions
Radiation Site Progression-free Survival Rate at 6 Months Using MRI Imaging	0.69 proportion of participants by arm Interval 0.6 to 0.77	0.75 proportion of participants by arm Interval 0.65 to 0.82

SECONDARY outcome

Timeframe: 6 months post radiation

Population: ITT population.

Proportion of participants who were alive at 6 months in study.

Outcome measures

Outcome measures
Measure	Standard Conventional Radiotherapy n=115 Participants Standard Conventional Radiotherapy (CRT) 20 Gy in 5 fractions 20 Gy in 5 fractions	Stereotactic Body Radiotherapy n=114 Participants Stereotactic Body Radiotherapy (SBRT) 24 Gy in 2 fractions Conventional SBRT: 24 Gy in 2 fractions
Overall Survival Rate at 6 Months	0.73 proportion of all participants Interval 0.64 to 0.81	0.77 proportion of all participants Interval 0.68 to 0.84

Adverse Events

Standard Conventional Radiotherapy

Serious events: 4 serious events

Other events: 17 other events

Deaths: 30 deaths

Stereotactic Body Radiotherapy

Serious events: 3 serious events

Other events: 9 other events

Deaths: 25 deaths

Serious adverse events

Serious adverse events
Measure	Standard Conventional Radiotherapy n=115 participants at risk Standard Conventional Radiotherapy (CRT) 20 Gy in 5 fractions 20 Gy in 5 fractions	Stereotactic Body Radiotherapy n=110 participants at risk Stereotactic Body Radiotherapy (SBRT) 24 Gy in 2 fractions Conventional SBRT: 24 Gy in 2 fractions
Gastrointestinal disorders Dysphagia	0.00% 0/115 • 6 months. Adverse events graded according to CTCAE V4.0 In the comments, it says that the number of patients in safety analysis does not agree with the patients flow chart. However, they are indeed different. As 115 and 114 were randomized to CRT and SBRT arm respectively, but there were 4 patients on SBRT arm did not receive any treatment, which leads to the difference. (Safety analyses were based on as-treated population)	0.91% 1/110 • Number of events 1 • 6 months. Adverse events graded according to CTCAE V4.0 In the comments, it says that the number of patients in safety analysis does not agree with the patients flow chart. However, they are indeed different. As 115 and 114 were randomized to CRT and SBRT arm respectively, but there were 4 patients on SBRT arm did not receive any treatment, which leads to the difference. (Safety analyses were based on as-treated population)
Gastrointestinal disorders Esophagitis	0.87% 1/115 • Number of events 1 • 6 months. Adverse events graded according to CTCAE V4.0 In the comments, it says that the number of patients in safety analysis does not agree with the patients flow chart. However, they are indeed different. As 115 and 114 were randomized to CRT and SBRT arm respectively, but there were 4 patients on SBRT arm did not receive any treatment, which leads to the difference. (Safety analyses were based on as-treated population)	0.00% 0/110 • 6 months. Adverse events graded according to CTCAE V4.0 In the comments, it says that the number of patients in safety analysis does not agree with the patients flow chart. However, they are indeed different. As 115 and 114 were randomized to CRT and SBRT arm respectively, but there were 4 patients on SBRT arm did not receive any treatment, which leads to the difference. (Safety analyses were based on as-treated population)
Gastrointestinal disorders Nausea	0.87% 1/115 • Number of events 1 • 6 months. Adverse events graded according to CTCAE V4.0 In the comments, it says that the number of patients in safety analysis does not agree with the patients flow chart. However, they are indeed different. As 115 and 114 were randomized to CRT and SBRT arm respectively, but there were 4 patients on SBRT arm did not receive any treatment, which leads to the difference. (Safety analyses were based on as-treated population)	0.00% 0/110 • 6 months. Adverse events graded according to CTCAE V4.0 In the comments, it says that the number of patients in safety analysis does not agree with the patients flow chart. However, they are indeed different. As 115 and 114 were randomized to CRT and SBRT arm respectively, but there were 4 patients on SBRT arm did not receive any treatment, which leads to the difference. (Safety analyses were based on as-treated population)
General disorders Fatigue	0.87% 1/115 • Number of events 1 • 6 months. Adverse events graded according to CTCAE V4.0 In the comments, it says that the number of patients in safety analysis does not agree with the patients flow chart. However, they are indeed different. As 115 and 114 were randomized to CRT and SBRT arm respectively, but there were 4 patients on SBRT arm did not receive any treatment, which leads to the difference. (Safety analyses were based on as-treated population)	0.00% 0/110 • 6 months. Adverse events graded according to CTCAE V4.0 In the comments, it says that the number of patients in safety analysis does not agree with the patients flow chart. However, they are indeed different. As 115 and 114 were randomized to CRT and SBRT arm respectively, but there were 4 patients on SBRT arm did not receive any treatment, which leads to the difference. (Safety analyses were based on as-treated population)
General disorders Pain	0.87% 1/115 • Number of events 1 • 6 months. Adverse events graded according to CTCAE V4.0 In the comments, it says that the number of patients in safety analysis does not agree with the patients flow chart. However, they are indeed different. As 115 and 114 were randomized to CRT and SBRT arm respectively, but there were 4 patients on SBRT arm did not receive any treatment, which leads to the difference. (Safety analyses were based on as-treated population)	0.00% 0/110 • 6 months. Adverse events graded according to CTCAE V4.0 In the comments, it says that the number of patients in safety analysis does not agree with the patients flow chart. However, they are indeed different. As 115 and 114 were randomized to CRT and SBRT arm respectively, but there were 4 patients on SBRT arm did not receive any treatment, which leads to the difference. (Safety analyses were based on as-treated population)
Injury, poisoning and procedural complications Spinal fracture	0.87% 1/115 • Number of events 1 • 6 months. Adverse events graded according to CTCAE V4.0 In the comments, it says that the number of patients in safety analysis does not agree with the patients flow chart. However, they are indeed different. As 115 and 114 were randomized to CRT and SBRT arm respectively, but there were 4 patients on SBRT arm did not receive any treatment, which leads to the difference. (Safety analyses were based on as-treated population)	0.91% 1/110 • Number of events 1 • 6 months. Adverse events graded according to CTCAE V4.0 In the comments, it says that the number of patients in safety analysis does not agree with the patients flow chart. However, they are indeed different. As 115 and 114 were randomized to CRT and SBRT arm respectively, but there were 4 patients on SBRT arm did not receive any treatment, which leads to the difference. (Safety analyses were based on as-treated population)
Metabolism and nutrition disorders Dehydration	0.87% 1/115 • Number of events 1 • 6 months. Adverse events graded according to CTCAE V4.0 In the comments, it says that the number of patients in safety analysis does not agree with the patients flow chart. However, they are indeed different. As 115 and 114 were randomized to CRT and SBRT arm respectively, but there were 4 patients on SBRT arm did not receive any treatment, which leads to the difference. (Safety analyses were based on as-treated population)	0.00% 0/110 • 6 months. Adverse events graded according to CTCAE V4.0 In the comments, it says that the number of patients in safety analysis does not agree with the patients flow chart. However, they are indeed different. As 115 and 114 were randomized to CRT and SBRT arm respectively, but there were 4 patients on SBRT arm did not receive any treatment, which leads to the difference. (Safety analyses were based on as-treated population)
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/115 • 6 months. Adverse events graded according to CTCAE V4.0 In the comments, it says that the number of patients in safety analysis does not agree with the patients flow chart. However, they are indeed different. As 115 and 114 were randomized to CRT and SBRT arm respectively, but there were 4 patients on SBRT arm did not receive any treatment, which leads to the difference. (Safety analyses were based on as-treated population)	0.91% 1/110 • Number of events 1 • 6 months. Adverse events graded according to CTCAE V4.0 In the comments, it says that the number of patients in safety analysis does not agree with the patients flow chart. However, they are indeed different. As 115 and 114 were randomized to CRT and SBRT arm respectively, but there were 4 patients on SBRT arm did not receive any treatment, which leads to the difference. (Safety analyses were based on as-treated population)

Other adverse events

Other adverse events
Measure	Standard Conventional Radiotherapy n=115 participants at risk Standard Conventional Radiotherapy (CRT) 20 Gy in 5 fractions 20 Gy in 5 fractions	Stereotactic Body Radiotherapy n=110 participants at risk Stereotactic Body Radiotherapy (SBRT) 24 Gy in 2 fractions Conventional SBRT: 24 Gy in 2 fractions
General disorders Pain	5.2% 6/115 • Number of events 6 • 6 months. Adverse events graded according to CTCAE V4.0 In the comments, it says that the number of patients in safety analysis does not agree with the patients flow chart. However, they are indeed different. As 115 and 114 were randomized to CRT and SBRT arm respectively, but there were 4 patients on SBRT arm did not receive any treatment, which leads to the difference. (Safety analyses were based on as-treated population)	2.7% 3/110 • Number of events 3 • 6 months. Adverse events graded according to CTCAE V4.0 In the comments, it says that the number of patients in safety analysis does not agree with the patients flow chart. However, they are indeed different. As 115 and 114 were randomized to CRT and SBRT arm respectively, but there were 4 patients on SBRT arm did not receive any treatment, which leads to the difference. (Safety analyses were based on as-treated population)
Musculoskeletal and connective tissue disorders Back pain	9.6% 11/115 • Number of events 11 • 6 months. Adverse events graded according to CTCAE V4.0 In the comments, it says that the number of patients in safety analysis does not agree with the patients flow chart. However, they are indeed different. As 115 and 114 were randomized to CRT and SBRT arm respectively, but there were 4 patients on SBRT arm did not receive any treatment, which leads to the difference. (Safety analyses were based on as-treated population)	5.5% 6/110 • Number of events 6 • 6 months. Adverse events graded according to CTCAE V4.0 In the comments, it says that the number of patients in safety analysis does not agree with the patients flow chart. However, they are indeed different. As 115 and 114 were randomized to CRT and SBRT arm respectively, but there were 4 patients on SBRT arm did not receive any treatment, which leads to the difference. (Safety analyses were based on as-treated population)

Additional Information

Dr. Keyue Ding

Canadian Cancer Trials Group

Phone: 16135336430

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place