Neoplasms

Symptoms and General Pathology

All Conditions

Neoplasm Metastasis

Neoplastic Processes

Standard Conventional Radiotherapy (CRT) 20 Gy in 5 fractions

Stereotactic Body Radiotherapy (SBRT) 24 Gy in 2 fractions

20 Gy in 5 fractions

Conventional SBRT: 24 Gy in 2 fractions

Arjun Sahgal

The purpose of this study is to find out if SBRT is better than CRT at controlling pain in the spine 3 months after receiving treatment.

This research is being done because while there is some evidence suggesting that SBRT may improve treatment for patients with spine metastases, more research is needed to determine if it is better than CRT. The first part of the randomized trial (phase II) looked at whether it was possible (feasible) to provide these treatments in cancer centres across Canada, by aiming to recruit 54 participants within 18 months. This part of the study was successfully completed in early 2017. The second component of this study, called a randomized phase III trial, is now underway. It involves recruiting another 124 participants to receive either CRT or SBRT, using the same study procedure as in the feasibility study. We will continue to obtain information about whether SBRT is better than CRT at controlling pain.

Study Comparing Stereotactic Body Radiotherapy vs Conventional Palliative Radiotherapy (CRT) for Spinal Metastases

A Randomized Phase II/III Study Comparing Stereotactic Body Radiotherapy(SBRT) Versus Conventional Palliative Radiotherapy (CRT) for Patients With Spinal Metastases

A Complete Pain Response is defined as a pain score of zero (0) at the treated site with no concomitant increase in analgesic intake (stable or reducing analgesics in daily oral morphine equivalent) .

Radiation site progression was defined as:

* Gross unequivocal increase in tumor volume or linear dimension \> 20%.
* Any new or progressive tumor within the epidural space.
* Neurologic deterioration attributable to pre-existing epidural disease with equivocal increased epidural disease dimensions on MRI.

Proportion of participants who were alive at 6 months in study.

Trans Tasman Radiation Oncology Group

Canadian Cancer Trials Group

Adverse events graded according to CTCAE V4.0

In the comments, it says that the number of patients in safety analysis does not agree with the patients flow chart. However, they are indeed different. As 115 and 114 were randomized to CRT and SBRT arm respectively, but there were 4 patients on SBRT arm did not receive any treatment, which leads to the difference. (Safety analyses were based on as-treated population)

Standard Conventional Radiotherapy (CRT) 20 Gy in 5 fractions

20 Gy in 5 fractions

Standard Conventional Radiotherapy

Stereotactic Body Radiotherapy (SBRT) 24 Gy in 2 fractions

Conventional SBRT: 24 Gy in 2 fractions

Stereotactic Body Radiotherapy

Total

Age, Continuous

Sex: Female, Male

Race and Ethnicity were not collected from any participant.

Race and Ethnicity Not Collected

Canada

Australia

Region of Enrollment

0: Fully active, able to carry on all pre-disease performance without restriction.

1. Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work.
2. Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50% of waking hours.

ECOG Performance Status

Pain score range from 0 (no pain) to 10 (pain as bad as you can imagine).

Worst pain score

SINS is used to assess the stability of the spine in patients with metastatic spinal cord compression. It ranges from 0 to 18; with 0-6 as stable, 7 - 12 as indeterminate and 13-18 instable.

Spots Global Cancer Trial Database for conventional sbrt: 24 gy in 2 fractions