| Protocol ID | NCT02608866 |
| Registration Date | 2015-11-20 |
| Status | Unknown Status |
| Sponsor | National Taiwan University Hospital |
| Country | Taiwan |
| Industry | not industry |
| Blinding | unblinded |
| Center Type | singel-center RCT |
| Scope | national RCT |
| First Patient In | 2015-11-16 |
| Last Patient Out | 2020-08-01 |
| Publication | n |
| Gender % | ALL |
| Mean Age | 20 Years - |
NCT02608866
A Prospective Randomized Clinical Trial of Single Versus Multiple Fractionated Stereotactic Spine Radiosurgery for Patients With Spinal Metastases
| Field |
CLAUDE
claude-sonnet-4-20250514 Thinking: claude-opus-4-20250514 5470ms / 11229 tok |
OPENAI
gpt-4o Thinking: o3 2581ms / 9605 tok |
GLM
glm-5.1 6570ms / 9793 tok |
Review |
|---|---|---|---|---|
| rct_type | parallel RCT | parallel RCT | parallel RCT | OK |
| cancer_status | Cancer | Cancer | Cancer | OK |
| non_cancer_spec | N/A | N/A | N/A | OK |
| setting_patient | outpatient | outpatient | outpatient | OK |
| setting_place |
other
hospital → other
shaky reasoning✓ Unanimous
Initial: hospital
Requery: other — This study delivers specialized stereotactic spine radiosurgery treatments which are typically performed in outpatient radiation therapy clinics or day treatment centers, not requiring hospital admission.
|
other
other → other
shaky reasoning✓ Unanimous
Initial: other
Requery: other — The trial involves stereotactic spine radiosurgery, which is typically administered in an outpatient or specialized clinic setting within a hospital, but not requiring hospital admission.
|
hospital | – |
| feasibility |
feasibility RCT
feasibility RCT → feasibility RCT → feasibility RCT
shaky reasoning✓ Unanimous
Initial: feasibility RCT
Requery: feasibility RCT — The study explicitly states it aims to determine the feasibility of delivering single-fraction versus multi-fraction stereotactic spine radiosurgery, with the primary outcome focused on treatment-related adverse events rather than clinical effectiveness.
Thinking: feasibility RCT — The brief summary explicitly states the purpose is 'to determine the feasibility of delivering single-fraction 16-Gy versus 3-fraction 24-Gy' radiation therapy.
|
feasibility RCT
fully powered RCT → fully powered RCT → feasibility RCT
shaky reasoning✓ Unanimous
Initial: fully powered RCT
Requery: fully powered RCT — The study enrollment is 68 with clinical outcomes related to toxicity and pain response, suggesting it is designed for clinical effectiveness rather than feasibility.
Thinking: feasibility RCT — Study explicitly states its aim is to determine feasibility of the two dosing schedules, and enrollment of 68 suggests a pilot-scale trial rather than a fully powered effectiveness study.
|
fully powered RCT | – |
| intervention_pharmacologic | no | no | no | OK |
| intervention_chemo_immuno_radio | yes | yes | yes | OK |
| intervention_complementary | no | no | no | OK |
| intervention_device | no | no | no | OK |
| intervention_psychological | no | no | no | OK |
| intervention_complex | no | no | no | OK |
| intervention_acp | no | no | no | OK |
| intervention_music | no | no | no | OK |
| intervention_screening | no | no | no | OK |
| intervention_palliative | no | no | no | OK |
| intervention_education | no | no | no | OK |
| intervention_digital | no | no | no | OK |
| intervention_other | no | no | no | OK |
| outcome_symptom | yes | yes | yes | OK |
| outcome_qol | yes | yes | yes | OK |
| outcome_dignity | no | no | no | OK |
| outcome_cost | no | no | no | OK |
| outcome_other |
yes
yes → yes
shaky reasoning✓ Unanimous
Initial: yes
Requery: yes — The study includes outcomes related to feasibility metrics and treatment-related adverse events/toxicity profiles that go beyond symptom/QoL assessment.
|
yes
no → yes
shaky reasoning✓ Unanimous
Initial: no
Requery: yes — The trial includes outcomes related to feasibility and prediction of risk factors (toxicity) not covered by symptom/QoL/dignity/cost categories.
|
yes | OK |
| pharmacologic_sub | N/A | N/A | N/A | OK |