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

Primary Purpose

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

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Spine Radiosurgery
Questionnaires
Sponsored by
M.D. Anderson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Malignant Neoplasms of Eye Brain and Other Parts of Central Nervous System focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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. Prognostic Index for Spinal Metastases (PRISM) group 1-3
  6. All patients must be able to lie supine
  7. 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
  8. 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.
  9. 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.
  10. All patients must have a vertebral body site to be treated located from T1 to L5
  11. 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.
  12. 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.
  13. Patients undergoing prior surgery or laser interstitial thermotherapy are allowed
  14. 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

Sites / Locations

  • University of Texas MD Anderson Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Spine Radiosurgery - 1 Dose

Spine Radiosurgery - 3 Doses

Arm Description

Participants receive spine radiosurgery in a single large dose.

Participants receive spine radiosurgery over 3 smaller doses.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Pain Relief Relative to Multi-Fraction Radiosurgery in Patients with Previously Irradiated Spinal Metastases
Pain relief assessed by items on the Brief Pain Inventory (BPI) that measure severity, location, and degree of relief due to therapy by use of narcotic and non-narcotic pain medications and steroids. Patients experiencing a decrease of 2 points in the worst pain score for 2 consecutive assessment visits considered to have "partial pain relief". Complete pain relief defined as an average pain score of 0 for 2 consecutive assessment visits.

Full Information

First Posted
January 19, 2017
Last Updated
June 5, 2023
Sponsor
M.D. Anderson Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT03028337
Brief Title
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

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 18, 2017 (Actual)
Primary Completion Date
May 30, 2024 (Anticipated)
Study Completion Date
May 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Spine Radiosurgery - 1 Dose
Arm Type
Experimental
Arm Description
Participants receive spine radiosurgery in a single large dose.
Arm Title
Spine Radiosurgery - 3 Doses
Arm Type
Active Comparator
Arm Description
Participants receive spine radiosurgery over 3 smaller doses.
Intervention Type
Radiation
Intervention Name(s)
Spine Radiosurgery
Other Intervention Name(s)
Radiotherapy, XRT
Intervention Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Questionnaires
Other Intervention Name(s)
Surveys
Intervention Description
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.
Primary Outcome Measure Information:
Title
Time to Local Failure Relative to Multi-Fraction Radiosurgery in Patients with Previously Irradiated Spinal Metastases
Description
Local failure determined based on the surveillance MRI scan by study musculoskeletal radiologist.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Pain Relief Relative to Multi-Fraction Radiosurgery in Patients with Previously Irradiated Spinal Metastases
Description
Pain relief assessed by items on the Brief Pain Inventory (BPI) that measure severity, location, and degree of relief due to therapy by use of narcotic and non-narcotic pain medications and steroids. Patients experiencing a decrease of 2 points in the worst pain score for 2 consecutive assessment visits considered to have "partial pain relief". Complete pain relief defined as an average pain score of 0 for 2 consecutive assessment visits.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amol J. Ghia, MD
Phone
713-563-2300
Email
CR_Study_Registration@mdanderson.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amol J. Ghia, MD
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Texas MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical Research Operations
Email
CR_Study_Registration@mdanderson.org

12. IPD Sharing Statement

Links:
URL
http://www.mdanderson.org
Description
MD Anderson Cancer Center

Learn more about this trial

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

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