| Protocol ID | NCT03804333 |
| Registration Date | 2019-01-15 |
| Status | Unknown Status |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna |
| Country | Italy |
| Industry | not industry |
| Blinding | unblinded |
| Center Type | singel-center RCT |
| Scope | national RCT |
| First Patient In | 2017-11-08 |
| Last Patient Out | 2023-11-08 |
| Publication | n |
| Gender % | ALL |
| Mean Age | 18 Years - |
NCT03804333
SHort Course Accelerated RadiatiON Therapy (SHARON) in Palliative Treatment of Pelvic Cancer: an Interventional, Randomized, Multicentric Study
| Field |
GLM
glm-5.1 5728ms / 8542 tok |
CLAUDE
claude-sonnet-4-20250514 Thinking: claude-opus-4-20250514 5033ms / 9779 tok |
OPENAI
gpt-4o Thinking: o3 5720ms / 8385 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
other
shaky reasoning✓ Unanimous
Initial: other
|
other
hospital → other → other
shaky reasoning✓ Unanimous
Initial: hospital
Requery: other — This is a radiation therapy study delivered in outpatient radiation oncology clinics, where patients receive daily fractionated treatments as outpatients rather than requiring hospital admission.
Thinking: other — This is outpatient radiation therapy where patients come for daily or twice-daily treatments at a radiation oncology department, not requiring hospital admission.
|
other
hospital → hospital → other
shaky reasoning✓ Unanimous
Initial: hospital
Requery: hospital — The intervention involves administering radiotherapy, which typically requires the use of hospital-based facilities for treatment.
Thinking: other — Radiotherapy sessions are delivered in an outpatient radiotherapy department, not requiring hospital admission.
|
OK |
| feasibility |
feasibility RCT
feasibility RCT
shaky reasoning✓ Unanimous
Initial: feasibility RCT
|
feasibility RCT
feasibility RCT → feasibility RCT
shaky reasoning✓ Unanimous
Initial: feasibility RCT
Requery: feasibility RCT — With only 54 participants enrolled and a primary outcome focused on assessing efficacy of a treatment scheme rather than definitive clinical effectiveness, this appears to be a feasibility study testing a new radiation protocol.
|
feasibility RCT
fully powered RCT → feasibility RCT
shaky reasoning✓ Unanimous
Initial: fully powered RCT
Requery: feasibility RCT — The enrollment count is 54 and seeks to assess efficacy rather than clinical effectiveness, suggesting a pilot study.
|
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 |
no
no
shaky reasoning✓ Unanimous
Initial: no
|
no
yes → no
shaky reasoning✓ Unanimous
Initial: yes
Requery: no — The intervention being tested is radiation therapy dosing schedules (standard vs short course radiotherapy), not palliative care consultation or service delivery - this is a radiation oncology study conducted in a palliative care setting.
|
no
no → no
shaky reasoning✓ Unanimous
Initial: no
Requery: no — The intervention is a radiation therapy regimen tested in a palliative care setting, not palliative care itself.
|
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 | OK |
| pharmacologic_sub | N/A | N/A | N/A | OK |