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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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 /=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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03028337
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

M.D. Anderson Cancer Center
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Amol J. Ghia, MD
Principal Investigator Affiliation M.D. Anderson Cancer Center
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Malignant Neoplasms of Eye Brain and Other Parts of Central Nervous System
Study Website: View Trial Website
Additional Details

Study Groups: Participant will be randomly assigned (as in the flip of a coin) to 1 of 2 study groups. This is done because no one knows if one study group is better, the same, or worse than the other group.

  • - If participant is in Group 1, they will receive spine radiosurgery in a single large dose.
  • - If participant is in Group 2, they will receive spine radiosurgery over 3 smaller doses, which is standard.
Length of Study Participation: Participant may continue taking part in the study as the doctor thinks it is in their best interest. Participant will no longer be able to take part if the disease gets worse, if intolerable side effects occur, or if they are unable to follow study directions. Participation on the study will be over after participant's last follow-up visit. Radiosurgery: Participant will have spine radiosurgery in either 1 or 3 treatments as described above. Participant will sign a separate consent for the surgery that explains the procedure and the risks. Study Visits: After surgery, at Months 3,6,9,12,18, and 24 and then every 6 months after that:
  • - Participant will have a physical exam, including a neurological exam (tests to check the functioning of their nerves, including tests of their strength and sensation.
  • - Participant will complete the same questionnaires they completed at the beginning of the study.
  • - Participant will have an MRI.
This is an investigational study. Delivering spine radiosurgery in a single large dose rather than over three smaller doses is considered investigational. Up to 80 participants will be enrolled in this study. All will take part at MD Anderson.

Arms & Interventions

Arms

Experimental: Spine Radiosurgery - 1 Dose

Participants receive spine radiosurgery in a single large dose.

Active Comparator: Spine Radiosurgery - 3 Doses

Participants receive spine radiosurgery over 3 smaller doses.

Interventions

Radiation: - Spine Radiosurgery

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).

Behavioral: - Questionnaires

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Houston, Texas

Status

Recruiting

Address

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030

Site Contact

Clinical Research Operations

[email protected]

713-563-2300

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