Comparing single and multiple doses of spine radiosurgery for spinal metastases

Single Versus Multifraction Salvage Spine Stereotactic Radiosurgery for Previously Irradiated Spinal Metastases: a Randomized Phase II Clinical Trial

This study is testing whether giving a single large dose of spine radiosurgery works better than three smaller doses for patients with spinal metastases who have already had radiation treatment.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: M.D. Anderson Cancer Center (other)
• Drugs / interventions: radiation
• Locations: 1 site (Houston, Texas)
• Trial ID: NCT03028337 on ClinicalTrials.gov

What this trial studies

This clinical research focuses on evaluating the effectiveness of spine radiosurgery delivered in a single large dose compared to the standard approach of administering it in three smaller doses for patients with previously irradiated spinal metastases. Participants will be randomly assigned to one of the two treatment groups, and their symptoms, pain levels, and quality of life will be monitored throughout the study. Follow-up visits will include physical and neurological exams, questionnaires, and MRI assessments to track progress and outcomes over time.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with histologically confirmed solid tumor malignancies and evidence of spinal metastasis who have previously received radiation therapy.

Not a fit: Patients who have not received prior radiation therapy or those with extensive spinal involvement beyond the study's criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a more effective treatment option for patients with spinal metastases, potentially improving their symptoms and quality of life.

How similar studies have performed: Other studies have explored various dosing strategies in radiation therapy, but this specific comparison of single versus multifraction radiosurgery for spinal metastases is relatively novel.

Eligibility criteria

Inclusion Criteria:

1. All patients must have histologic proof of solid tumor malignancy and radiographic evidence of spine metastasis
2. Age \>/=18 years
3. Eastern Cooperative Oncology Group (ECOG) performance status \</=2 (Karnofsky \>/=60%)
4. Life expectancy of greater than 6 months
5. All patients must be able to lie supine
6. All patients must have no more than 3 contiguous vertebral body levels treated at a single site, and no more than 3 discontiguous vertebral body levels treated
7. All patients must have radiographic evidence of progression at a spinal site previously irradiated greater than 6 months prior to randomization. This includes indirect radiation exposure to spinal site.
8. All patients must have received prior conventional external-beam radiation therapy (cEBRT) to the site of interest to no more than a critical neural tissue dose equivalent dose (EQD)2/2 of 42 Gy in a single session or 50 Gy cumulative over multiple sessions and cauda equina dose EQD2/2 of 50 Gy in a single session or 60 Gy cumulative over multiple session. EQD2/2 is calculated as follows: EQD2/2= biologically effective dose (BED)/(1+d/alpha beta)) where BED=nd(1+d/(alpha beta)) and n=number of fractions, d=dose per fraction and alpha beta ratio of 2.
9. All patients must have a vertebral body site to be treated located from T1 to L5
10. Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.
11. All patients must sign informed consent verifying that they are aware of the investigational nature of this study in keeping with the rules and policies of MD Anderson Cancer Center. The only acceptable consent is the one approved by MD Anderson IRB.
12. Patients undergoing prior surgery or laser interstitial thermotherapy are allowed
13. Both men and women of all races and ethnic groups are eligible for this trial.

Exclusion Criteria:

1. Patients unable to undergo magnetic resonance imaging (MRI) of the spine
2. Prior radiation at the site of interest within 6 months
3. Prior history of radiation at the site of interest resulting in a critical neural tissue dose of EQD2/2 of \>42 Gy in a single session
4. Patients unable to lie flat comfortably for 2 hours
5. Pregnancy status will be obtained at time of consent as is routine for all radiation patients. Pregnant women are excluded from this study because radiation has the potential for teratogenic or abortifacient effects
6. Patients with a histology of lymphoma and myeloma histologies

Where this trial is running

Houston, Texas

• University of Texas MD Anderson Cancer Center — Houston, Texas, United States (RECRUITING)

Study contacts

• Principal investigator: Amol J. Ghia, MD — M.D. Anderson Cancer Center
• Study coordinator: Amol J. Ghia, MD

Conditions: Malignant Neoplasms of Eye Brain and Other Parts of Central Nervous System, Malignant neoplasms of eye brain and other parts of central nervous system, Solid tumor malignancy, Radiographic evidence of spine metastasis, Spine radiosurgery, Radiation therapy, Radiotherapy, Questionnaires