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Radiotherapy + Vertebroplasty for Spinal Metastases

Phase 2

Waitlist Available

Research Sponsored by AHS Cancer Control Alberta

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients with painful (VAS of at least ≥ 2) vertebral spinal metastases in the thoracic and /or lumbar spine (not cervical)

No prior EBRT to the target +/-1 vertebral body level

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1,3,6 and 12 months post treatment

Awards & highlights

Study Summary

This trial is testing whether combining vertebroplasty (a procedure to stabilize the spine) with radiotherapy (RT) is more effective than RT alone for patients with spinal metastases.

Who is the study for?

This trial is for adults with painful spinal metastases confirmed by imaging, who can perform daily activities (ECOG score 0-2 or Karnofsky ≥60%), and have a life expectancy over 6 months. It's not for those with certain conditions like plasmacytoma, prior radiotherapy in the same spine region, or spinal cord compression. Participants must be able to follow the study plan and use effective birth control if of childbearing potential.Check my eligibility

What is being tested?

The trial tests combining vertebroplasty (a procedure that stabilizes the spine) with radiotherapy against radiotherapy alone in patients with spinal metastases. The goal is to see if this combination provides better pain relief, prevents vertebral fractures, and reduces opioid need compared to just using radiotherapy.See study design

What are the potential side effects?

Potential side effects include pain at the injection site from vertebroplasty, new or worsening back pain, risks associated with cement leaking during vertebroplasty such as nerve damage or blood clots, and typical side effects from radiotherapy like skin irritation and fatigue.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have painful spine cancer in my mid or lower back.

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I haven't had radiation therapy to the specific spine area being targeted.

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I am 18 years old or older.

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My cancer has spread to the bones in my spine, confirmed by scans.

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I can take care of myself and perform daily activities.

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I agree not to donate sperm during the study.

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I am not breastfeeding while receiving study treatment.

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I am a woman who can have children and have a negative pregnancy test.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1,3,6 and 12 months post treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1,3,6 and 12 months post treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1,3,6 and 12 months post treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Improvement in Pain Score based on the Brief Pain Inventory

Improvement in Pain Score based on the Visual Analog Scale

Secondary outcome measures

Changes in back-specific physical functioning

Incidence of vertebral compression fractures post treatment.

Prospectively quantify pain response using the Brief Pain Inventory.

+1 more

Side effects data

From 2016 Phase 3 trial • 854 Patients • NCT00003389

98%

Anemia

93%

Leukocytes decreased

90%

Lymphopenia

84%

Neutrophils decreased

78%

Neuropathy-sensory

75%

Alopecia

74%

Fatigue

67%

Nausea

60%

Hyperglycemia

52%

Constipation

46%

Hypoalbuminemia

40%

Myalgia

34%

Stomatitis

33%

Insomnia

32%

Vomiting

27%

Platelets decreased

26%

Alkaline phosphatase increased

26%

Aspartate aminotransferase increased

23%

Dyspnea

20%

Dyspepsia

19%

Dysphagia

19%

Headache

16%

Anorexia

16%

Arthralgia

15%

Neuropathy-motor

15%

Abdominal pain

14%

Infection w/o neutropenia

14%

Cough

14%

Fever

13%

Rash/desquamation

13%

Diarrhea w/o prior colostomy

12%

Bone pain

11%

Weight gain

11%

Taste disturbance

11%

Anxiety/agitation

10%

Sweating

10%

Radiation dermatitis

Rigors/chills

Dizziness/lightheadedness

Injection site reaction

Hypoglycemia

Dysphagia-esophageal radiation

Blood bilirubin increased

Chest pain

Pain-other

Phlebitis

Creatinine increased

Edema

Pruritus

Hot flashes

Infection w/ grade 3 or 4 neutropenia

Weight loss

Muscle weakness

Depression

Mouth dryness

Transfusion: pRBCs

Pneumonitis/pulmonary infiltrates

Thrombosis/embolism

Febrile neutropenia

Irregular menses

Nail changes

Allergic rhinitis

Allergic reaction

Infection w/ unknown ANC

Syncope

Sinus tachycardia

Dehydration

Neuropathic pain

100%

80%

60%

40%

20%

Study treatment Arm

Arm B (Stanford V)

Arm A (ABVD)

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Vertebroplasty + RadiotherapyExperimental Treatment2 Interventions

Vertebroplasty followed by radiotherapy within 2-3 weeks Radiotherapy dose: 20 Gy/5 fractions/1 week or 8 Gy/1 fraction (at the discretion of the Radiation Oncologist)

Group II: RadiotherapyActive Control1 Intervention

Radiotherapy dose: 20 Gy/5 fractions/1 week or 8 Gy/1 fraction (at the discretion of the Radiation Oncologist)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Radiotherapy

2017

Completed Phase 3

~2610

0 / 8Eligibility criteria met

Find a Location

Who is running the clinical trial?

AHS Cancer Control AlbertaLead Sponsor

182 Previous Clinical Trials

36,148 Total Patients Enrolled

Cross Cancer InstituteOTHER

61 Previous Clinical Trials

19,126 Total Patients Enrolled

Media Library

Radiotherapy Clinical Trial Eligibility Overview. Trial Name: NCT04242589 — Phase 2

Spinal Metastases Research Study Groups: Radiotherapy, Vertebroplasty + Radiotherapy

Spinal Metastases Clinical Trial 2023: Radiotherapy Highlights & Side Effects. Trial Name: NCT04242589 — Phase 2

Radiotherapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT04242589 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA granted approval for Radiotherapy?

"The safety of radiotherapy has been rated a 2 out of 3, as this is currently in its second stage of clinical trials and data exists to support the treatment's security, though no evidence yet demonstrates its efficacy."

Answered by AI

Are there currently any enrollments open for this research trial?

"As per the clinicaltrials.gov record, this particular medical trial has already completed its patient recruitment phase which began on May 1st 2020 and ended on April 9th 2020. Nonetheless, there are 637 other active trials that patients can join at present."

Answered by AI

What is the desired outcome of this experiment?

"This study, which will be monitored for a period of twelve months post-treatment, aims to quantify the improvement in pain scores as measured by the Visual Analog Scale. Secondary objectives involve assessing the rate of vertebral compression fractures through standing lateral spine radiographs and back-specific physical functioning via changes in RDQ score. Pain response is tracked using BPI and calculated OMED based on intake of analgesics stored in patient diaries following International Bone Metastases Working Party Criteria guidelines."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Trial of Combined Radiotherapy and Vertebroplasty for Patients With Painful Metastatic Spinal Lesions

2020. "Trial of Combined Radiotherapy and Vertebroplasty for Patients With Painful Metastatic Spinal Lesions". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04242589.