Trial Outcomes & Findings for Radiotherapy for Solid Tumor Spine Metastases (NCT NCT01752036)
NCT ID: NCT01752036
Last Updated: 2020-06-25
Results Overview
To estimate the rate of radiographic local recurrence at 12 months in patients treated with a post-operative stereotactic radiosurgery boost for resected spine metastases.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
35 participants
Primary outcome timeframe
1 year
Results posted on
2020-06-25
Participant Flow
33 of the 35 enrolled participants received treatment.
Participant milestones
| Measure |
Treatment
Post-operative, Stereotactic Body Radiation Therapy (SBRT): All participants received SBRT at 600 cGy x 5 fractions
|
|---|---|
|
Overall Study
STARTED
|
33
|
|
Overall Study
COMPLETED
|
31
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Treatment
Post-operative, Stereotactic Body Radiation Therapy (SBRT): All participants received SBRT at 600 cGy x 5 fractions
|
|---|---|
|
Overall Study
Death
|
2
|
Baseline Characteristics
Radiotherapy for Solid Tumor Spine Metastases
Baseline characteristics by cohort
| Measure |
Treatment
n=35 Participants
Post-operative, Stereotactic Body Radiation Therapy (SBRT): All participants received SBRT at 600 cGy x 5 fractions
|
|---|---|
|
Age, Continuous
|
63 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
24 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
35 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 yearTo estimate the rate of radiographic local recurrence at 12 months in patients treated with a post-operative stereotactic radiosurgery boost for resected spine metastases.
Outcome measures
| Measure |
Treatment
n=31 Participants
Post-operative, Stereotactic Body Radiation Therapy (SBRT): All participants received SBRT at 600 cGy x 5 fractions
|
|---|---|
|
Number of Participants With Radiographic Recurrence at 12 Months
|
3 Participants
|
PRIMARY outcome
Timeframe: 1 yearTo estimate the time (in months) to radiographic local recurrence in patients treated with a post-operative stereotactic radiosurgery boost for resected spine metastases.
Outcome measures
| Measure |
Treatment
n=31 Participants
Post-operative, Stereotactic Body Radiation Therapy (SBRT): All participants received SBRT at 600 cGy x 5 fractions
|
|---|---|
|
Time to Local Recurrence
|
3.5 months
Interval 3.4 to 5.8
|
SECONDARY outcome
Timeframe: 1 yearTo estimate the rate of re-treatment at 12 months in patients treated with a post-operative stereotactic radiosurgery boost for resected spine metastases
Outcome measures
| Measure |
Treatment
n=31 Participants
Post-operative, Stereotactic Body Radiation Therapy (SBRT): All participants received SBRT at 600 cGy x 5 fractions
|
|---|---|
|
Number of Participants Receiving Re-treatment
|
2 Participants
|
SECONDARY outcome
Timeframe: 1 yearTo estimate the rate of symptomatic local recurrence at 12 months in patients treated with a post-operative stereotactic radiosurgery boost for resected spine metastases
Outcome measures
| Measure |
Treatment
n=31 Participants
Post-operative, Stereotactic Body Radiation Therapy (SBRT): All participants received SBRT at 600 cGy x 5 fractions
|
|---|---|
|
Number of Participants With Symptomatic Recurrence
|
31 Participants
|
SECONDARY outcome
Timeframe: 1 yearNumber of participants experiencing radiation myelopathy in patients treated with a post-operative stereotactic radiosurgery boost for resected spine metastases
Outcome measures
| Measure |
Treatment
n=31 Participants
Post-operative, Stereotactic Body Radiation Therapy (SBRT): All participants received SBRT at 600 cGy x 5 fractions
|
|---|---|
|
Number of Participants Experiencing Radiation Myelopathy
|
0 Participants
|
SECONDARY outcome
Timeframe: 1 yearNumber of participants treated with a post-operative stereotactic radiosurgery boost for resected spine metastases, experiencing wound dehiscence.
Outcome measures
| Measure |
Treatment
n=31 Participants
Post-operative, Stereotactic Body Radiation Therapy (SBRT): All participants received SBRT at 600 cGy x 5 fractions
|
|---|---|
|
Number of Participants Experiencing Wound Dehiscence
|
0 Participants
|
SECONDARY outcome
Timeframe: 1 yearTime in months to return to chemotherapy in patients treated with a post-operative stereotactic radiosurgery boost for resected spine metastases.
Outcome measures
| Measure |
Treatment
n=31 Participants
Post-operative, Stereotactic Body Radiation Therapy (SBRT): All participants received SBRT at 600 cGy x 5 fractions
|
|---|---|
|
Time to Return to Chemotherapy
|
0.5 months
Interval 0.0 to 9.4
|
SECONDARY outcome
Timeframe: 1 yearPopulation: Only 3 participants had radio-sensitive tumors.
To evaluate the post-treatment symptomatic local recurrence in patients with radio-sensitive tumors.
Outcome measures
| Measure |
Treatment
n=3 Participants
Post-operative, Stereotactic Body Radiation Therapy (SBRT): All participants received SBRT at 600 cGy x 5 fractions
|
|---|---|
|
Number of Participants With Radio-sensitive Tumors Who Had Symptomatic Local Recurrence
|
3 Participants
|
Adverse Events
Treatment
Serious events: 0 serious events
Other events: 31 other events
Deaths: 2 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Treatment
n=33 participants at risk
Post-operative, Stereotactic Body Radiation Therapy (SBRT): All participants received SBRT at 600 cGy x 5 fractions
|
|---|---|
|
Gastrointestinal disorders
Constipation
|
67.7%
21/31 • 1 year
Adverse Events were defined by Radiation Therapy Oncology Group (RTOG) and European Organisation for Research and Treatment of Cancer (EORTC) criteria.
|
|
General disorders
Cough
|
25.8%
8/31 • 1 year
Adverse Events were defined by Radiation Therapy Oncology Group (RTOG) and European Organisation for Research and Treatment of Cancer (EORTC) criteria.
|
|
Psychiatric disorders
Depression
|
58.1%
18/31 • 1 year
Adverse Events were defined by Radiation Therapy Oncology Group (RTOG) and European Organisation for Research and Treatment of Cancer (EORTC) criteria.
|
|
Gastrointestinal disorders
Diarrhea
|
19.4%
6/31 • 1 year
Adverse Events were defined by Radiation Therapy Oncology Group (RTOG) and European Organisation for Research and Treatment of Cancer (EORTC) criteria.
|
|
General disorders
Dizziness
|
25.8%
8/31 • 1 year
Adverse Events were defined by Radiation Therapy Oncology Group (RTOG) and European Organisation for Research and Treatment of Cancer (EORTC) criteria.
|
|
General disorders
Dry mouth
|
38.7%
12/31 • 1 year
Adverse Events were defined by Radiation Therapy Oncology Group (RTOG) and European Organisation for Research and Treatment of Cancer (EORTC) criteria.
|
|
Psychiatric disorders
Agitation
|
51.6%
16/31 • 1 year
Adverse Events were defined by Radiation Therapy Oncology Group (RTOG) and European Organisation for Research and Treatment of Cancer (EORTC) criteria.
|
|
Psychiatric disorders
Akathisia
|
9.7%
3/31 • 1 year
Adverse Events were defined by Radiation Therapy Oncology Group (RTOG) and European Organisation for Research and Treatment of Cancer (EORTC) criteria.
|
|
Metabolism and nutrition disorders
Alkaline phosphatase increased
|
9.7%
3/31 • 1 year
Adverse Events were defined by Radiation Therapy Oncology Group (RTOG) and European Organisation for Research and Treatment of Cancer (EORTC) criteria.
|
|
Blood and lymphatic system disorders
Anemia
|
77.4%
24/31 • 1 year
Adverse Events were defined by Radiation Therapy Oncology Group (RTOG) and European Organisation for Research and Treatment of Cancer (EORTC) criteria.
|
|
Psychiatric disorders
Anorexia
|
54.8%
17/31 • 1 year
Adverse Events were defined by Radiation Therapy Oncology Group (RTOG) and European Organisation for Research and Treatment of Cancer (EORTC) criteria.
|
|
Psychiatric disorders
Anxiety
|
51.6%
16/31 • 1 year
Adverse Events were defined by Radiation Therapy Oncology Group (RTOG) and European Organisation for Research and Treatment of Cancer (EORTC) criteria.
|
|
Gastrointestinal disorders
AST increased
|
12.9%
4/31 • 1 year
Adverse Events were defined by Radiation Therapy Oncology Group (RTOG) and European Organisation for Research and Treatment of Cancer (EORTC) criteria.
|
|
Gastrointestinal disorders
Bloating
|
32.3%
10/31 • 1 year
Adverse Events were defined by Radiation Therapy Oncology Group (RTOG) and European Organisation for Research and Treatment of Cancer (EORTC) criteria.
|
|
General disorders
Chills rigors
|
9.7%
3/31 • 1 year
Adverse Events were defined by Radiation Therapy Oncology Group (RTOG) and European Organisation for Research and Treatment of Cancer (EORTC) criteria.
|
|
General disorders
Concentration impairment
|
29.0%
9/31 • 1 year
Adverse Events were defined by Radiation Therapy Oncology Group (RTOG) and European Organisation for Research and Treatment of Cancer (EORTC) criteria.
|
|
Gastrointestinal disorders
Dyspepsia
|
32.3%
10/31 • 1 year
Adverse Events were defined by Radiation Therapy Oncology Group (RTOG) and European Organisation for Research and Treatment of Cancer (EORTC) criteria.
|
|
Nervous system disorders
Dyphagia
|
12.9%
4/31 • 1 year
Adverse Events were defined by Radiation Therapy Oncology Group (RTOG) and European Organisation for Research and Treatment of Cancer (EORTC) criteria.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
22.6%
7/31 • 1 year
Adverse Events were defined by Radiation Therapy Oncology Group (RTOG) and European Organisation for Research and Treatment of Cancer (EORTC) criteria.
|
|
Metabolism and nutrition disorders
Edema extremities
|
9.7%
3/31 • 1 year
Adverse Events were defined by Radiation Therapy Oncology Group (RTOG) and European Organisation for Research and Treatment of Cancer (EORTC) criteria.
|
|
General disorders
Fatigue
|
93.5%
29/31 • 1 year
Adverse Events were defined by Radiation Therapy Oncology Group (RTOG) and European Organisation for Research and Treatment of Cancer (EORTC) criteria.
|
|
Gastrointestinal disorders
Gastritis
|
19.4%
6/31 • 1 year
Adverse Events were defined by Radiation Therapy Oncology Group (RTOG) and European Organisation for Research and Treatment of Cancer (EORTC) criteria.
|
|
General disorders
Headache
|
19.4%
6/31 • 1 year
Adverse Events were defined by Radiation Therapy Oncology Group (RTOG) and European Organisation for Research and Treatment of Cancer (EORTC) criteria.
|
|
General disorders
Insomnia
|
16.1%
5/31 • 1 year
Adverse Events were defined by Radiation Therapy Oncology Group (RTOG) and European Organisation for Research and Treatment of Cancer (EORTC) criteria.
|
|
Metabolism and nutrition disorders
Localized edema
|
12.9%
4/31 • 1 year
Adverse Events were defined by Radiation Therapy Oncology Group (RTOG) and European Organisation for Research and Treatment of Cancer (EORTC) criteria.
|
|
Blood and lymphatic system disorders
Lymphocyte count decreased
|
19.4%
6/31 • 1 year
Adverse Events were defined by Radiation Therapy Oncology Group (RTOG) and European Organisation for Research and Treatment of Cancer (EORTC) criteria.
|
|
Blood and lymphatic system disorders
Lymphocytes absolute decreased
|
25.8%
8/31 • 1 year
Adverse Events were defined by Radiation Therapy Oncology Group (RTOG) and European Organisation for Research and Treatment of Cancer (EORTC) criteria.
|
|
General disorders
Malaise
|
22.6%
7/31 • 1 year
Adverse Events were defined by Radiation Therapy Oncology Group (RTOG) and European Organisation for Research and Treatment of Cancer (EORTC) criteria.
|
|
Gastrointestinal disorders
Nausea
|
54.8%
17/31 • 1 year
Adverse Events were defined by Radiation Therapy Oncology Group (RTOG) and European Organisation for Research and Treatment of Cancer (EORTC) criteria.
|
|
Musculoskeletal and connective tissue disorders
Neuralgia
|
51.6%
16/31 • 1 year
Adverse Events were defined by Radiation Therapy Oncology Group (RTOG) and European Organisation for Research and Treatment of Cancer (EORTC) criteria.
|
|
General disorders
Pain
|
19.4%
6/31 • 1 year
Adverse Events were defined by Radiation Therapy Oncology Group (RTOG) and European Organisation for Research and Treatment of Cancer (EORTC) criteria.
|
|
Surgical and medical procedures
Pain due to RT
|
9.7%
3/31 • 1 year
Adverse Events were defined by Radiation Therapy Oncology Group (RTOG) and European Organisation for Research and Treatment of Cancer (EORTC) criteria.
|
|
Blood and lymphatic system disorders
Platelet count decreased
|
19.4%
6/31 • 1 year
Adverse Events were defined by Radiation Therapy Oncology Group (RTOG) and European Organisation for Research and Treatment of Cancer (EORTC) criteria.
|
|
Gastrointestinal disorders
Stomach pain
|
35.5%
11/31 • 1 year
Adverse Events were defined by Radiation Therapy Oncology Group (RTOG) and European Organisation for Research and Treatment of Cancer (EORTC) criteria.
|
|
Nervous system disorders
Tremor
|
32.3%
10/31 • 1 year
Adverse Events were defined by Radiation Therapy Oncology Group (RTOG) and European Organisation for Research and Treatment of Cancer (EORTC) criteria.
|
|
Metabolism and nutrition disorders
Weight loss
|
48.4%
15/31 • 1 year
Adverse Events were defined by Radiation Therapy Oncology Group (RTOG) and European Organisation for Research and Treatment of Cancer (EORTC) criteria.
|
|
Blood and lymphatic system disorders
White blood cell count decreased
|
29.0%
9/31 • 1 year
Adverse Events were defined by Radiation Therapy Oncology Group (RTOG) and European Organisation for Research and Treatment of Cancer (EORTC) criteria.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place