NCT02376933 · REGISTRY CONDITION SEARCH

Vertebral Augmentation and Radiotherapy of Collapse Spinal Metastatic Cancer

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: NA
Status at capture: TERMINATED
Registry last update: 2018-11-07

Vertebral augmentation with radiotherapy to increase the functional status and quality of life for patients with vertebral body metastatic cancers.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

→

baseline

Baseline characteristics

→

outcome · POSTED

Pain Assessment From the Worst Pain Score on Brief Pain Inventory as Compared to Historical Radiation Therapy Oncology Group (RTOG) 9714 Study.

→

outcome · POSTED

Activity Level Assessment From the Roland Morris Questionnaire (RDQ) and Karnofsky Performance Status (KPS)

→

outcome · POSTED

Quality of Life Assessment From the EORTC QLQ C30 Questionnaire.

→

outcome · POSTED

Fracture Rates Detected From X-rays.

→

adverse events

Adverse events

→

more info

Limitations, agreements, and source contact

→

Who could take part

eligibility Criteria: Inclusion Criteria: * Diagnosis of metastatic disease to the vertebra or multiple myeloma * Negative pregnancy test within 2 weeks prior to registration * Life expectancy of \>= 3 months and Karnofsky performance status (KPS) score \>= 40 * Pain scale score \>=5 * Pain at involved vertebral body not adequately controlled * Osteolysis of vertebral bodies * Must agree to practice adequate means of birth control * Must sign informed consent prior to study entry * Must be able to understand the English language * Absence of any serious cognitive or psychiatric problems potentially hampering compliance with the study and follow-up schedule. Exclusion Criteria: * Spinal Cord Compression
healthy Volunteers: false
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
Vertebroplasty with Radiotherapy is given in either order. Radiotherapy dosage is at the discretion of the treating physician. Vertebroplasty is applied to fractured vertebrae.
intervention Names
Procedure: Vertebroplasty
Radiation: Radiotherapy
label
Vertebroplasty with Radiotherapy
type
EXPERIMENTAL

interventions

arm Group Labels
Vertebroplasty with Radiotherapy
description
Under imaging guidance, a fractured vertebral body is stabilized with injected bone cement.
name
Vertebroplasty
other Names
kyphoplasty
type
PROCEDURE
arm Group Labels
Vertebroplasty with Radiotherapy
description
Radiotherapy of metastatic lesions to the spine.
name
Radiotherapy
type
RADIATION

Study design

allocation

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 11
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
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
measure
Pain Assessment From the Worst Pain Score on Brief Pain Inventory as Compared to Historical Radiation Therapy Oncology Group (RTOG) 9714 Study.
time Frame
14 weeks

secondary Outcomes

description
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).
measure
Activity Level Assessment From the Roland Morris Questionnaire (RDQ) and Karnofsky Performance Status (KPS)
time Frame
14 weeks
description
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.
measure
Quality of Life Assessment From the EORTC QLQ C30 Questionnaire.
time Frame
14 weeks
measure
Fracture Rates Detected From X-rays.
time Frame
14 weeks

Full study description

brief Summary: Vertebral augmentation with radiotherapy to increase the functional status and quality of life for patients with vertebral body metastatic cancers.
detailed Description: The study quantifies the reduction of pain and changes in quality of life associated with vertebral augmentation. This study is conducted in patients with metastatic cancer or multiple myeloma involving the spine. This study addresses the value of vertebral augmentation in combination with radiotherapy in the setting of cancer to the spine. The patient's pain, overall quality of life, and fracture development/avoidance will be compared to patients treated only with radiotherapy in the past.

Source references

Source notices and limitations

Discovery and provenance

release id
ctgov-registry-1336d216cbd1bbff780dac70
edge id
nct-edge-3605e2427268b9f8ecd0
requested nct id
NCT02376933
primary nct id
NCT02376933
source kind
ctgov_condition_query
source url
https://clinicaltrials.gov/api/v2/studies?query.cond=Plasma+Cell+Neoplasms&filter.advanced=AREA%5BHasResults%5Dtrue&pageSize=1000&format=json&countTotal=true
source record id
Source null
source file sha256
2314ce01316b2d7044d298c6d25eda12e99cc5f44273bc75efed6cd5e03a8c14
payload sha256
becb31d11080e9cd39fbb7e96778e8d229c21b05c3499f5ffd9effba92420ddf
payload
clinical indication matching status
condition_index_match_asserted_by_registry_not_reviewed
end exclusive
true
id
nct-edge-3605e2427268b9f8ecd0
link basis
returned_by_explicit_condition_and_posted_results_filter_query
nct id
NCT02376933
occurrences
context exact
NCT02376933
end
11
exact text
NCT02376933
start
0
offset unit
unicode_code_points
query cond
Plasma Cell Neoplasms
query disease state id
ds-plasma-cell-neoplasms
source file
/Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-plasma-cell-neoplasms-000.json
source file sha256
2314ce01316b2d7044d298c6d25eda12e99cc5f44273bc75efed6cd5e03a8c14
source json pointer
/studies/919/protocolSection/identificationModule/nctId
source kind
ctgov_condition_query
source record id
Source null
source string basis
parsed_JSON_string_unmodified
source string sha256
1aef25938db8fc32a7c64f6e698be78ea43efeddb7413bf92a03a833ff3d3cd5
source url
https://clinicaltrials.gov/api/v2/studies?query.cond=Plasma+Cell+Neoplasms&filter.advanced=AREA%5BHasResults%5Dtrue&pageSize=1000&format=json&countTotal=true

Preserved source evidence · Not medical advice