Single Versus Multifraction Salvage Spine Stereotactic Radiosurgery for Previously Irradiated Spinal Metastases

NCT03028337 | Active Not Recruiting Phase 2 DMC

• 2 other identifiers: 2016-0728NCI-2017-00606
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical research study is to learn whether delivering spine radiosurgery in a single large dose is better than delivering spine radiosurgery over 3 smaller doses. Researchers also want to learn about the effects of a single dose on participant's symptoms, pain, and quality-of-life.

Conditions

Malignant Neoplasms of Eye Brain and Other Parts of Central Nervous System

Keywords

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; Surveys; XRT

Outcome Measures

Primary Outcomes (1)

• Time to Local Failure Relative to Multi-Fraction Radiosurgery in Patients with Previously Irradiated Spinal Metastases

  Local failure determined based on the surveillance MRI scan by study musculoskeletal radiologist.

  12 months

Secondary Outcomes (1)

• Pain Relief Relative to Multi-Fraction Radiosurgery in Patients with Previously Irradiated Spinal Metastases

  2 years

Study Arms (2)

Spine Radiosurgery - 1 Dose

EXPERIMENTAL

Participants receive spine radiosurgery in a single large dose.

Radiation: Spine Radiosurgery; Behavioral: Questionnaires

Spine Radiosurgery - 3 Doses

ACTIVE COMPARATOR

Participants receive spine radiosurgery over 3 smaller doses.

Radiation: Spine Radiosurgery; Behavioral: Questionnaires

Interventions

Spine Radiosurgery RADIATION

Spine Radiosurgery - 1 Dose: For single fraction and multifraction arms, 0.01 cc of the cord allowed to receive 10 Gy and 14 Gy, respectively while 0.01 cc of the cauda equina allowed to receive 14 Gy and 18 Gy, respectively. Spine Radiosurgery - 3 Doses (3 days): The dose for the multifraction arm is 27 Gy in 3 fractions (9 Gy per fraction).

Also known as: Radiotherapy, XRT

Spine Radiosurgery - 1 Dose; Spine Radiosurgery - 3 Doses

Questionnaires BEHAVIORAL

Participants complete 3 questionnaires about any pain they may be having, quality-of-life, and any other symptoms. It should take about 10 minutes to complete these questionnaires. Questionnaires completed at Baseline and at Months 3,6,9,12,18, and 24 and then every 6 months after that during follow up.

Also known as: Surveys

Spine Radiosurgery - 1 Dose; Spine Radiosurgery - 3 Doses

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients must have histologic proof of solid tumor malignancy and radiographic evidence of spine metastasis
• Age \>/=18 years
• Eastern Cooperative Oncology Group (ECOG) performance status \</=2 (Karnofsky \>/=60%)
• Life expectancy of greater than 6 months
• All patients must be able to lie supine
• 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
• 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.
• 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.
• All patients must have a vertebral body site to be treated located from T1 to L5
• 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.
• 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.
• Patients undergoing prior surgery or laser interstitial thermotherapy are allowed
• Both men and women of all races and ethnic groups are eligible for this trial.

You may not qualify if:

• Patients unable to undergo magnetic resonance imaging (MRI) of the spine
• Prior radiation at the site of interest within 6 months
• 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
• Patients unable to lie flat comfortably for 2 hours
• 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
• Patients with a histology of lymphoma and myeloma histologies

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• MD Anderson Cancer Center

MeSH Terms

Interventions

Radiotherapy; Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Therapeutics; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Amol J. Ghia, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2017
• First Posted: January 23, 2017
• Study Start: January 18, 2017
• Primary Completion (Estimated): May 30, 2028
• Study Completion (Estimated): May 30, 2028
• Last Updated: March 5, 2026

Record last verified: 2026-03

Locations

US (1)