| Protocol ID | NCT03947268 |
| Registration Date | 2019-05-13 |
| Status | completed |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna |
| Country | – |
| Industry | not industry |
| Blinding | unblinded |
| Center Type | – |
| Scope | – |
| First Patient In | 2009-01-01 |
| Last Patient Out | 2019-01-01 |
| Publication | n |
| Gender % | ALL |
| Mean Age | 18 Years - |
NCT03947268
Palliative Short-course Radiotherapy in Advanced Pelvic Cancer: a Phase II Study (SHARON Project)
| Field |
GLM
glm-5.1 8408ms / 8469 tok |
OPENAI
gpt-4o Thinking: o3 5083ms / 8325 tok |
CLAUDE
claude-sonnet-4-20250514 Thinking: claude-opus-4-20250514 4795ms / 9695 tok |
Review |
|---|---|---|---|---|
| rct_type | N/A | N/A | N/A | 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 | hospital | hospital | hospital | OK |
| feasibility |
N/A
N/A → N/A
shaky reasoning✓ Unanimous
Initial: N/A
Requery: N/A — The study is a single-group interventional study without randomization or a control group, making it an observational/non-randomized design rather than an RCT.
|
N/A
feasibility RCT → feasibility RCT → N/A
shaky reasoning✓ Unanimous
Initial: feasibility RCT
Requery: feasibility RCT — The study has an enrollment count of 25, which suggests it is a feasibility or pilot study focused on defining safety and efficacy.
Thinking: N/A — Single-group phase II study without randomization, therefore not an RCT.
|
N/A
feasibility RCT → fully powered RCT → N/A
shaky reasoning✓ Unanimous
Initial: feasibility RCT
Requery: fully powered RCT — This is a single-arm phase II study designed to evaluate safety and efficacy of a palliative radiotherapy intervention with clinical endpoints (pain, toxicity, quality of life) rather than feasibility outcomes, despite the small enrollment of 25 patients.
Thinking: N/A — Single-arm interventional study with no randomization or control group, therefore not an RCT
|
OK |
| 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 | yes | yes | yes | 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 |
no
yes → yes
shaky reasoning✓ Unanimous
Initial: yes
Requery: yes — The primary and secondary outcomes include measures of safety and treatment-emergent adverse events (toxicity), which are not covered by the symptom, QoL, dignity, or cost categories.
|
no
no → no → no
shaky reasoning✓ Unanimous
Initial: no
Requery: no — All outcomes listed are related to symptom management, quality of life, or toxicity, which fits the categories of symptom/QoL.
Thinking: no — All specified outcomes concern pain, toxicity, and quality of life, which fall under symptom/QoL categories.
|
no
yes → no → no
shaky reasoning✓ Unanimous
Initial: yes
Requery: no — All outcomes focus on symptom assessment (pain via VAS scale), quality of life (via CLAS scale), and treatment safety/toxicity, which fall within the symptom/QoL categories.
Thinking: no — All outcomes measure symptoms (pain, toxicity) or quality of life, with no caregiver, survival, or other non-symptom/QoL outcomes assessed.
|
OK |
| pharmacologic_sub | N/A | N/A | N/A | OK |