| Protocol ID | NCT05566574 |
| Registration Date | 2022-10-04 |
| Status | active, not recruiting |
| Sponsor | Memorial Sloan Kettering Cancer Center |
| Country | United States |
| Industry | not industry |
| Blinding | unblinded |
| Center Type | multicenter RCT |
| Scope | national RCT |
| First Patient In | 2022-09-30 |
| Last Patient Out | 2026-09-30 |
| Publication | n |
| Gender % | ALL |
| Mean Age | 18 Years - |
NCT05566574
RP-3500 (ATRi) + External Beam Radiotherapy (EBRT) for the Palliative Treatment of Metastatic Disease
| Field |
GLM
glm-5.1 6502ms / 9614 tok |
CLAUDE
claude-sonnet-4-20250514 Thinking: claude-opus-4-20250514 9394ms / 11042 tok |
OPENAI
gpt-4o Thinking: o3 3065ms / 9435 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 | hospital | hospital | hospital | OK |
| feasibility |
N/A
fully powered RCT → N/A
shaky reasoning✓ Unanimous
Initial: fully powered RCT
Requery: N/A — This is a Phase 1/Phase 2 interventional trial designed to determine the maximum tolerated dose and assess safety/local control, rather than being an observational study or a fully powered clinical effectiveness RCT.
|
N/A
fully powered RCT → fully powered RCT → N/A
shaky reasoning✓ Unanimous
Initial: fully powered RCT
Requery: fully powered RCT — This is a phase I/II study with n=49 designed to determine safety/tolerability (phase I) and assess 6-month local control rate (phase II), which represents a clinical effectiveness endpoint with adequate sample size for a powered analysis.
Thinking: N/A — This is a single-arm Phase 1/2 dose-escalation study without randomization or control group, not an RCT.
|
N/A
feasibility RCT → N/A → N/A
shaky reasoning✓ Unanimous
Initial: feasibility RCT
Requery: N/A — The study is an interventional trial focused on safety and dose finding, indicative of an exploratory phase I/II study, not an RCT.
Thinking: N/A — Single‐arm phase 1/2 safety study, not a randomized controlled trial
|
OK |
| intervention_pharmacologic | yes | yes | yes | 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 | yes | yes | yes | OK |
| intervention_acp | no | no | no | OK |
| intervention_music | no | no | no | OK |
| intervention_screening | no | no | no | OK |
| intervention_palliative |
no
no → no
shaky reasoning✓ Unanimous
Initial: no
Requery: no — The trial tests the study drug RP-3500 in combination with radiation therapy for the palliative treatment of metastatic cancer, making palliative care the setting rather than the intervention itself.
|
no
no → no
shaky reasoning✓ Unanimous
Initial: no
Requery: no — This study tests the safety and efficacy of a combination drug therapy (RP-3500 + external beam radiotherapy) in patients with metastatic cancer, where palliative care is the setting/context rather than the intervention being studied.
|
no
yes → no
shaky reasoning✓ Unanimous
Initial: yes
Requery: no — The intervention being tested is a drug (RP-3500) in combination with radiation therapy, 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 |
no
yes → no
shaky reasoning✓ Unanimous
Initial: yes
Requery: no — The primary outcomes focus on safety/tolerability (adverse events) and local control rate, with no specific symptom measures using validated instruments listed.
|
no
no → no
shaky reasoning✓ Unanimous
Initial: no
Requery: no — The primary outcomes focus on safety/tolerability assessment via adverse events (DLT graded by NCI CTCAE) and local control rate through imaging, with no validated symptom-specific instruments or direct symptom measures.
|
no
no → no
shaky reasoning✓ Unanimous
Initial: no
Requery: no — The trial does not mention any specific symptom measures or validated symptom assessment instruments.
|
OK |
| outcome_qol | no | no | no | OK |
| outcome_dignity | no | no | no | OK |
| outcome_cost | no | no | no | OK |
| outcome_other | yes | yes | yes | OK |
| pharmacologic_sub | not yet FDA/EMA approved | not yet FDA/EMA approved | not yet FDA/EMA approved | OK |