Health Trials

Spine Radiosurgery for Symptomatic Metastatic Neoplasms

ConditionsMetastatic Neoplasm to the SpineMetastatic Neoplasm
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Oklahoma

About this trial

The purpose of this study is to compare three types of radiation therapy for cancer that has spread to the spine. The two types of radiation therapy used in this trial are External Beam Radiation Therapy (EBRT) and Stereotactic Body Radiation Therapy (SBRT). EBRT delivers tightly targeted radiation beams from outside the body. SBRT is a specialized type of radiation therapy that allows high doses of radiation to small targets. This study will include standard dose SBRT and higher dose SBRT. Each participant will be randomly assigned to either EBRT, standard dose SBRT, or higher dose SBRT.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participant must have histologic confirmation of malignancy. Spinal metastatic disease must be confirmed by imaging.

Participant must have received no prior therapies for this disease. Prior therapy includes previous radiation therapy encompassing the anatomic site to be treated with spine SBRT. This includes any previous radiation therapy where the treatment field overlaps with the anatomic site to be treated with spine SBRT (even if that previous radiation therapy was not for treatment of spinal disease). Systemic radiation therapy for metastatic disease such as Pluvicto also counts as previous radiation therapy.

Age >18 years. This study requires informed consent by the participant; as children are not able to perform this without parental approval, Participant < age 18 are excluded from this study.

Life expectancy of≥ 3 months, in the opinion of and as documented by the investigator.

Disqualifiers

Participant receiving any other investigational agents.

Participant with prognosis less than 3 months will be excluded from this clinical trial because of their poor prognosis and decreased likelihood to meet the primary endpoint

Participant with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.

Pregnant or nursing Participant are excluded due to toxicity of radiation therapy.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Conventional external beam radiation therapy dose (EBRT)

    Radiation

    Participants will undergo 8 Gray in 1 fraction of EBRT. Questionnaires (brief pain inventory, COST-FACIT, EuroQol EQ-5D) will be administered at baseline, and again at 3,6,9,12 month follow-up.

  • Spine radiosurgery/stereotactic body radiation therapy standard dose

    Radiation

    Participants will undergo 24 Gray in 2 fractions of SBRT. Questionnaires (brief pain inventory, COST-FACIT, EuroQol EQ-5D) will be administered at baseline, and again at 3,6,9,12 month follow-up.

  • Spine radiosurgery/stereotactic body radiation therapy high dose

    Radiation

    Participants will undergo 19 Gray in 1 fraction of SBRT. Questionnaires (brief pain inventory, COST-FACIT, EuroQol EQ-5D) will be administered at baseline, and again at 3,6,9,12 month follow-up.

Treatment groups

240 Participants
are divided into 3 treatment groups
Group A: Standard SBRTExperimental treatment 1 intervention
Group B: High Dose SBRT (SOC)Experimental treatment 1 intervention
Group C: Conventional EBRT (SOC)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Proportion of patients who experience 3-month pain freedom based on BPI score

Freedom from pain at 3 months defined as pain freedom following spine SBRT/EBRT per the Brief Pain Inventory (BPI), which is a scale of 1-10. The complete response for pain freedom is defined as a "worst" pain score of 0 on the BPI. Partial pain freedom is defined as a "worst" pain score of 2 points on the BPI.

Time frame
3 months

Secondary outcomes

1

Proportion of patients who experienced 6-month pain freedom based on the BPI score

Freedom from pain at 6 months defined as pain freedom following spine SBRT/EBRT per the Brief Pain Inventory (BPI), which is a scale of 1-10. The complete response for pain freedom is defined as a "worst" pain score of 0 on the BPI. Partial pain freedom is defined as a "worst" pain score of 2 points on the BPI.

Time frame
6 months
2

Local control actuarial rate at 6-months

6-month local control, defined as an actuarial 6-month rate of any new, recurrent or progressing (as defined by SPINOcriteria) tumor within the planning target volume on any post-treatment MRI by 6 months. Follow-up MRIs will be fused with the planning scan for this assessment

Time frame
6 months
3

Vertebral compression fracture rate at 6-months

6-month vertebral compression fracture rate, assessed by post-treatment MRI by 6 months

Time frame
6 months
4

Proportion of patients who experienced progression-free survival

Overall participant survival

Time frame
6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Oklahoma

Lead sponsor

Source ClinicalTrials.gov
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