NCT05617716

Spine Radiosurgery for Symptomatic Metastatic Neoplasms

Spine Patient Optimal Radiosurgery Treatment for Symptomatic Metastatic Neoplasms (SPORTSMEN) Multicenter Randomized Phase II Clinical Trial

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 240 (estimated)
• Sponsor: University of Oklahoma · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Metastatic spine cancer incidence is increasing; the primary treatment is radiation therapy. Metastatic spine disease has been historically treated with external beam radiation therapy (EBRT) with conventional fractionation, yielding relatively limited durability in pain control. The increased lifespan of patients with metastatic cancer has resulted in an increase in the incidence of spine metastases, which has led to a need for more durable treatment results. Stereotactic radiosurgery (SRS)/Stereotactic body radiation therapy (SBRT) of the spine has exponentially increased, with the theoretical advantages of higher tumoricidal dose and more rapid fall off between tumor and surrounding normal tissue compared with EBRT. The goal of this study is to compare three types of radiation therapy to draw conclusions on what is an effective treatment to reduce pain and increase pain freedom rates. Patients in this trial will be randomized in a 1:1:1 ratio into one of three treatment arms: SBRT (24 Gy in 2 fractions), SBRT (19 Gy in 1 fraction), or conventional EBRT (8 Gy in 1 fraction). Participants will complete three questionnaires-the Brief Pain Inventory, COST-FACIT, and EuroQol EQ-5D-at baseline and again during the 3- to 12-month follow-up period.

Conditions

• Metastatic Neoplasm to the Spine
• Metastatic Neoplasm

Interventions

Type	Name	Description
RADIATION	Conventional external beam radiation therapy dose (EBRT)	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.
RADIATION	Spine radiosurgery/stereotactic body radiation therapy standard dose	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.
RADIATION	Spine radiosurgery/stereotactic body radiation therapy high dose	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.

Timeline

• Start date: 2025-09-09
• Primary completion: 2028-09-30
• Completion: 2029-09-30
• First posted: 2022-11-15
• Last updated: 2025-10-20

Locations

2 sites across 1 country: United States