Trial Outcomes & Findings for Vertebral Augmentation and Radiotherapy of Collapse Spinal Metastatic Cancer (NCT NCT02376933)

Last Updated: 2018-11-07

Results Overview

Assessment of the patient's pain, activities and quality of life will be gathered from the patient in returning for follow-up or by contacting the patient by phone approximately 1 week following the completion of their first procedure, whether it be the vertebral augmentation or the radiotherapy (5 - 10 days following). Mandatory assessments include: \- Worst Pain Score - Brief Pain Inventory (BPI) - The Worst Pain Assessment on the Brief Inventory Scale is an assessment tool of current pain intensity and pain intensity within the last 24 hours when not on pain control medications. 0 being no pain and 10 is the worst pain possible. See protocol attachments

Recruitment status

TERMINATED

Study phase

Target enrollment

11 participants

Primary outcome timeframe

14 weeks

Results posted on

2018-11-07

Participant Flow

Participant milestones

Participant milestones
Measure	Vertebroplasty With Radiotherapy Vertebroplasty with Radiotherapy is given in either order. Radiotherapy dosage is at the discretion of the treating physician. Vertebroplasty is applied to fractured vertebrae. Vertebroplasty: Under imaging guidance, a fractured vertebral body is stabilized with injected bone cement. Radiotherapy: Radiotherapy of metastatic lesions to the spine.
Overall Study STARTED	10
Overall Study COMPLETED	8
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Vertebral Augmentation and Radiotherapy of Collapse Spinal Metastatic Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Vertebroplasty With Radiotherapy n=10 Participants Vertebroplasty with Radiotherapy is given in either order. Radiotherapy dosage is at the discretion of the treating physician. Vertebroplasty is applied to fractured vertebrae. Vertebroplasty: Under imaging guidance, a fractured vertebral body is stabilized with injected bone cement. Radiotherapy: Radiotherapy of metastatic lesions to the spine.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=5 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants

PRIMARY outcome

Timeframe: 14 weeks

Population: Study terminated when PI left institution; data not collected.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 14 weeks

Population: Study terminated when PI left institution; data not collected.

Roland-Morris Disability Questionnaire - The score of the RDQ is the total number of items checked - i.e. from a minimum of 0 (best) to a maximum of 24 (worst). Karnofsky Performance Status (KPS) - scale from 10 (moribund, fatal processes progressing rapidly) to 100 (normal, no complaints, no evidence of disease).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 14 weeks

Population: Study terminated when PI left institution; data not collected.

EORTC QLQ-C30 (version 3) - The QLQ-C30 is composed of both multi-item scales and single-item measures. These include five functional scales, three symptom scales, a global health status / QoL scale, and six single items. Each of the multi-item scales includes a different set of items - no item occurs in more than one scale. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Thus a high score for a functional scale represents a high / healthy level of functioning,a high score for the global health status / QoL represents a high QoL,but a high score for a symptom scale / item represents a high level of symptomatology / problems.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 14 weeks

Population: Study terminated when PI left institution; data not collected.

Outcome measures

Outcome data not reported

Adverse Events

Vertebroplasty With Radiotherapy

Serious events: 2 serious events

Other events: 5 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Vertebroplasty With Radiotherapy n=10 participants at risk Vertebroplasty with Radiotherapy is given in either order. Radiotherapy dosage is at the discretion of the treating physician. Vertebroplasty is applied to fractured vertebrae. Vertebroplasty: Under imaging guidance, a fractured vertebral body is stabilized with injected bone cement. Radiotherapy: Radiotherapy of metastatic lesions to the spine.
Gastrointestinal disorders Gastrointestinal - other	10.0% 1/10
Musculoskeletal and connective tissue disorders Back pain	10.0% 1/10

Other adverse events

Other adverse events
Measure	Vertebroplasty With Radiotherapy n=10 participants at risk Vertebroplasty with Radiotherapy is given in either order. Radiotherapy dosage is at the discretion of the treating physician. Vertebroplasty is applied to fractured vertebrae. Vertebroplasty: Under imaging guidance, a fractured vertebral body is stabilized with injected bone cement. Radiotherapy: Radiotherapy of metastatic lesions to the spine.
Musculoskeletal and connective tissue disorders Back pain	50.0% 5/10
Musculoskeletal and connective tissue disorders Bone pain	10.0% 1/10
Gastrointestinal disorders Constipation	10.0% 1/10
Respiratory, thoracic and mediastinal disorders Cough	10.0% 1/10
Metabolism and nutrition disorders Dehydration	10.0% 1/10
Gastrointestinal disorders Diarrhea	10.0% 1/10
Skin and subcutaneous tissue disorders Dry skin	10.0% 1/10
Respiratory, thoracic and mediastinal disorders Dyspnea	10.0% 1/10
Injury, poisoning and procedural complications Fall	10.0% 1/10
General disorders Fatigue	20.0% 2/10
General disorders Flu-like syndrome	10.0% 1/10
Gastrointestinal disorders Nausea	10.0% 1/10
General disorders Pain	30.0% 3/10
Gastrointestinal disorders Vomiting	20.0% 2/10

Additional Information

Program Coordinator

University of Arizona Cancer Center

Phone: 520-626-0301

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place