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

Primary Purpose

Spinal Metastases

Status

Not yet recruiting

Phase

Phase 2

Locations

Canada

Study Type

Interventional

Intervention

Radiotherapy

Vertebropladty

About this trial

This is an interventional treatment trial for Spinal Metastases focused on measuring Vertebroplasty, Vertebral Compression Fracture, Radiotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Participants capable of giving informed consent, or if appropriate, participants having an acceptable individual capable of giving consent on the participant's behalf
Patients must be 18 years of age or older
Spinal vertebral metastases confirmed by CT, MRI or bone scan.
Patients with painful (VAS of at least ≥ 2) vertebral spinal metastases in the thoracic and /or lumbar spine (not cervical).
Patients must be willing and able to comply with schedule visits, treatment plan, tests and other study procedures
Life expectancy > 6 months. Life expectancy will be evaluated by the study investigator both clinically and by using Linden model. Patient should be in the group B or C of the Linden model.
Patients with an ECOG score 0-2 or Karnofsky performance status of ≥ 60% will be eligible for enrolment (see appendix 1).
No prior EBRT to the target +/-1 vertebral body level
Women of child bearing potential (WOCBP) must have a negative serum (or urine) pregnancy test at the time of screening. WOCBP is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy or bilateral salpingectomy) and is not postmenopausal. Menopause is defined as 12 months of amenorrhea in a woman over age 45 years in the absence of other biological or physiological causes. In addition, females under the age of 55 years must have a serum follicle stimulating hormone, (FSH) level > 40 mIU/mL to confirm menopause
Patients of childbearing / reproductive potential should use highly effective birth control methods, as defined by the investigator, during the study treatment period. A highly effective method of birth control is defined as those that result in low failure rate (i.e. less than 1% per year) when used consistently and correctly (Note: abstinence is acceptable if this is established and preferred contraception for the patient and is accepted as a local standard) .
Females must not breastfeed during study treatment.
Male patients should agree to not donate sperm during study treatment.
Absence of any condition hampering compliance with study protocols and follow-up schedule; those conditions should be reviewed with the patient prior to trial registration

Exclusion Criteria

Patient cannot provide consent
Prior radiotherapy to the target +/-1 vertebral body level
Life expectancy < 6 months (assessed both clinically and using Linden model)
Karnofsky performance status of < 60%
Primary bone tumors
Plasmacytoma
Communicated fracture
Associated Impending cord compression or spinal cord compression
Epidural involvement

Sites / Locations

Cross Cancer Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Radiotherapy

Vertebroplasty + Radiotherapy

Arm Description

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

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)

Outcomes

Primary Outcome Measures

Improvement in Pain Score based on the Visual Analog Scale

The primary end point is the improvement in pain score of at least 2 points (a decrease of 2 points) on the visual analogue Scale (VAS) without concurrent increase in opioids.

Improvement in Pain Score based on the Brief Pain Inventory

The primary end point is the improvement in pain score of at least 2 points (a decrease of 2 points) on the Brief Pain Inventory (BPI) without concurrent increase in opioids.

Secondary Outcome Measures

Changes in back-specific physical functioning

The improvement in back-specific physical functioning is evaluated by the change in Roland-Morris disability questionnaire (RDQ) score.

Incidence of vertebral compression fractures post treatment.

The incidence of vertebral compression fractures will be evaluated by standing lateral spine radiographs of the thoracic and lumbar vertebrae.

Prospectively quantify pain response using the Visual Analog Scale

Pain response will be assessed by VAS and evaluated using a patient diary based on the International Bone Metastases Working Party Criteria. Based on intake of analgesics, the daily oral morphine equivalent dose (OMED) will be calculated.

Prospectively quantify pain response using the Brief Pain Inventory.

Pain response will be assessed by BPI and evaluated using a patient diary based on the International Bone Metastases Working Party Criteria. Based on intake of analgesics, the daily oral morphine equivalent dose (OMED) will be calculated.

Full Information

NCT ID

NCT04242589

First Posted

January 21, 2020

Last Updated

April 9, 2020

Sponsor

AHS Cancer Control Alberta

Collaborators

Cross Cancer Institute

1. Study Identification

Unique Protocol Identification Number

NCT04242589

Brief Title

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

Official Title

A Phase II Randomized Trial of Combined Radiotherapy and Vertebroplasty to Improve the Quality of Life of Patients With Painful Metastatic Localized Spinal Lesions

Study Type

Interventional

2. Study Status

Record Verification Date

January 2020

Overall Recruitment Status

Not yet recruiting

Study Start Date

May 1, 2020 (Anticipated)

Primary Completion Date

September 1, 2022 (Anticipated)

Study Completion Date

March 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

AHS Cancer Control Alberta

Collaborators

Cross Cancer Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Since patients with spinal metastases are living longer, durable palliation with long-term tumor control are becoming increasingly important. EBRT results in durable local control of bone metastasis. However, about 25 % of patients with spinal metastases only achieved complete pain relief following EBRT for a median duration of less than 4 months. This could be partly due to spinal instability. In addition, almost half of the patients who receive EBRT will subsequently develop VCFs . Hence, RT does not stabilize the spine secondary to VCFs and is not effective in preventing imminent VCFs. Vertebroplasty has rapidly reduced pain and improved function in patients with VCFs. However, vertebroplasty does not provide local tumor control similar to EBRT. It is theorized that combining vertebroplasty with EBRT will stabilize the spine, relieve the pain, prevent imminent VCFs and minimize or avoid the need for opioids. It is hypothesized that combining a spine stabilization procedure such as vertebroplasty with RT will be the most effective management for patients with spinal metastases than RT alone for patients with spinal metastases. Combined vertebroplasty and radiotherapy is not a standard treatment option at present. This study is designed to quantify the advantage of adding vertebroplasty to radiotherapy for patients with spinal metastases. If the study is proven to be significant, it could become the standard of care for patients with spinal metastases.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Spinal Metastases

Keywords

Vertebroplasty, Vertebral Compression Fracture, Radiotherapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

64 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Radiotherapy

Arm Type

Active Comparator

Arm Description

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

Arm Title

Vertebroplasty + Radiotherapy

Arm Type

Experimental

Arm Description

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)

Intervention Type

Radiation

Intervention Name(s)

Radiotherapy

Other Intervention Name(s)

External Beam Radiation Therapy

Intervention Description

External beam radiation therapy is a type of radiation therapy used for cancer treatment. A machine is used to aim high-energy rays from outside the body into tumor

Intervention Type

Procedure

Intervention Name(s)

Vertebropladty

Intervention Description

Vertebroplasty is a procedure for stabilizing compression fractures in the spine. Bone cement is injected into vertebrae that have cracked or broken. The cement hardens, stabilizing the fractures and supporting your spine.

Primary Outcome Measure Information:

Title

Improvement in Pain Score based on the Visual Analog Scale

Description

The primary end point is the improvement in pain score of at least 2 points (a decrease of 2 points) on the visual analogue Scale (VAS) without concurrent increase in opioids.

Time Frame

1,3,6 and 12 months post treatment

Title

Improvement in Pain Score based on the Brief Pain Inventory

Description

The primary end point is the improvement in pain score of at least 2 points (a decrease of 2 points) on the Brief Pain Inventory (BPI) without concurrent increase in opioids.

Time Frame

1,3,6 and 12 months post treatment

Secondary Outcome Measure Information:

Title

Changes in back-specific physical functioning

Description

The improvement in back-specific physical functioning is evaluated by the change in Roland-Morris disability questionnaire (RDQ) score.

Time Frame

1,3,6 and 12 months post treatment

Title

Incidence of vertebral compression fractures post treatment.

Description

The incidence of vertebral compression fractures will be evaluated by standing lateral spine radiographs of the thoracic and lumbar vertebrae.

Time Frame

Baseline, 6 months and 12 months

Title

Prospectively quantify pain response using the Visual Analog Scale

Description

Time Frame

1,3,6 and 12 months post treatment

Title

Prospectively quantify pain response using the Brief Pain Inventory.

Description

Time Frame

1,3,6 and 12 months post treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Participants capable of giving informed consent, or if appropriate, participants having an acceptable individual capable of giving consent on the participant's behalf Patients must be 18 years of age or older Spinal vertebral metastases confirmed by CT, MRI or bone scan. Patients with painful (VAS of at least ≥ 2) vertebral spinal metastases in the thoracic and /or lumbar spine (not cervical). Patients must be willing and able to comply with schedule visits, treatment plan, tests and other study procedures Life expectancy > 6 months. Life expectancy will be evaluated by the study investigator both clinically and by using Linden model. Patient should be in the group B or C of the Linden model. Patients with an ECOG score 0-2 or Karnofsky performance status of ≥ 60% will be eligible for enrolment (see appendix 1). No prior EBRT to the target +/-1 vertebral body level Women of child bearing potential (WOCBP) must have a negative serum (or urine) pregnancy test at the time of screening. WOCBP is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy or bilateral salpingectomy) and is not postmenopausal. Menopause is defined as 12 months of amenorrhea in a woman over age 45 years in the absence of other biological or physiological causes. In addition, females under the age of 55 years must have a serum follicle stimulating hormone, (FSH) level > 40 mIU/mL to confirm menopause Patients of childbearing / reproductive potential should use highly effective birth control methods, as defined by the investigator, during the study treatment period. A highly effective method of birth control is defined as those that result in low failure rate (i.e. less than 1% per year) when used consistently and correctly (Note: abstinence is acceptable if this is established and preferred contraception for the patient and is accepted as a local standard) . Females must not breastfeed during study treatment. Male patients should agree to not donate sperm during study treatment. Absence of any condition hampering compliance with study protocols and follow-up schedule; those conditions should be reviewed with the patient prior to trial registration Exclusion Criteria Patient cannot provide consent Prior radiotherapy to the target +/-1 vertebral body level Life expectancy < 6 months (assessed both clinically and using Linden model) Karnofsky performance status of < 60% Primary bone tumors Plasmacytoma Communicated fracture Associated Impending cord compression or spinal cord compression Epidural involvement

Facility Information:

Facility Name

Cross Cancer Institute

City

Edmonton

State/Province

Alberta

ZIP/Postal Code

T6G 1Z2

Country

Canada

12. IPD Sharing Statement

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

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