RTOG-0631
Terminated
Protocol Information
Phase II/III Study of Image-Guided Radiosurgery/SBRT for Localized Spine Metastasis
Principal Investigator
Samuel Ryu
Status
Terminated
Open to Accrual
September 22, 2011
Closed to Accrual
August 4, 2017
Closed to Accrual & Treatment
August 5, 2017
Closed to Accrual & Treatment
August 16, 2017
Terminated
April 6, 2020
Disease Site
Symptom Management [CC] Other
Phase
II/III
Developmental Therapeutics
No
Primary Objective
Phase II Component: Determine the feasibility of successfully delivering image-guided radiosurgery/SBRT for spine metastases in a cooperative group setting.Completed.
Phase III Component: Determine whether image-guided radiosurgery/SBRT (single dose of 16 Gy) improves pain control (as measured by the 11 point NRPS) as compared to conventional external beam radiotherapy (single dose of 8 Gy).
Data Collection Notice:
Data for this trial is being collected via the NRG/RTOG Data Center.
Patient Population
Patients with localized spine metastasis from the C1 to L5 levels (a solitary spine metastasis; 2 separate spine levels; or up to 3 separate sites); each of the separate sites must have a maximal involvement of 2 contiguous vertebral bodies.
Data Collection Notice:
Data for this trial is being collected via the NRG/RTOG Data Center.
Target Accrual
352
Protocol Documents
Available via the National Cancer Institute (NCI) Cancer Trials Support Unit (CTSU) website.
- A5-Demographic-Data-Form.pdf
- AE-Adverse-Event-Evaluation-Form.pdf
- Demographic-Data-Form-Instructions.pdf
- FA-FACT-G-Quality-of-Life-Form.pdf
- F1-Follow-up-Form.pdf
- Dosimetry-Transmittal-Form.pdf
- Forms-Package-Index.pdf
- HP-Health-Utility-Measurement-Euro-EQ-5D.pdf
- I1-Initial-Evaluation-Form.pdf
- T1-Radiation-Therapy-Form.pdf
- QL-BPI-Brief-Pain-Inventory.pdf
- Numeric-Rate-Pain-Scale.pdf
- 0631-Study-Memorandum-10-31-16.pdf
- RTOG-0631-call-for-data-memo-9.19.16.pdf
- RTOG-0631-Closure-Notice-August-2-2017-FINAL.pdf
- RTOG-0631-Study-Memorandum-8.24.15.pdf
- RTOG-0631-Study-Memorandum-Closure-August-4-2017.pdf
- RTOG-0631-Study-Memorandum-Amendment-10-October-31-2016.pdf
- RTOG-0631-Study-Memorandum-Amendment-9-August-24-2015.pdf
- RTOG-0631-Study-Memorandum-Termination-April-6-2020.pdf