Clinical trial NCT03028337: Single Versus Multifraction Salvage Spine Stereotactic Radiosurgery for Previously Irradiated Spinal Metastases
Official title: Single Versus Multifraction Salvage Spine Stereotactic Radiosurgery for Previously Irradiated Spinal Metastases: a Randomized Phase II Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
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
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2017-01-23
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Detailed description: 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.

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

Primary outcomes:
measure: Time to Local Failure Relative to Multi-Fraction Radiosurgery in Patients with Previously Irradiated Spinal Metastases
timeFrame: 12 months
Secondary outcomes:
measure: Pain Relief Relative to Multi-Fraction Radiosurgery in Patients with Previously Irradiated Spinal Metastases
timeFrame: 2 years
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Amol J. Ghia, MD
role: PRINCIPAL_INVESTIGATOR
References: