| Protocol ID | NCT03409848 |
| Registration Date | 2018-01-24 |
| Status | completed |
| Sponsor | AIO-Studien-gGmbH |
| Country | Germany |
| Industry | not industry |
| Blinding | unblinded |
| Center Type | multicenter RCT |
| Scope | national RCT |
| First Patient In | 2018-03-01 |
| Last Patient Out | 2022-03-05 |
| Publication | n |
| Gender % | ALL |
| Mean Age | 18 Years - |
NCT03409848
Ipilimumab or FOLFOX in Combination With Nivolumab and Trastuzumab in Previously Untreated HER2 Positive Locally Advanced or Metastatic EsophagoGastric Adenocarcinoma
| Field |
GLM
glm-5.1 6454ms / 11258 tok |
OPENAI
gpt-4o 2360ms / 11038 tok |
CLAUDE
claude-sonnet-4-20250514 9779ms / 12984 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 → other
shaky reasoning✓ Unanimous
Initial: other
Requery: other — This is an outpatient oncology trial for ambulatory patients (ECOG 0-1) receiving systemic drug infusions (immunotherapy and chemotherapy) at a clinical facility without the requirement for hospital admission.
|
other
hospital → other
shaky reasoning✓ Unanimous
Initial: hospital
Requery: other — The clinical trial involves outpatient administration of drugs (e.g., Nivolumab, Ipilimumab) that do not require hospital admission, indicating a setting of outpatient clinics or community settings.
|
other
other → other
shaky reasoning✓ Unanimous
Initial: other
Requery: other — This is an oncology trial with intravenous drug infusions delivered at 35 outpatient cancer treatment centers, not requiring hospitalization.
|
OK |
| feasibility | fully powered RCT | fully powered RCT | fully powered RCT | 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 | OK |
| intervention_education | no | no | no | OK |
| intervention_digital | no | no | no | OK |
| intervention_other | no | no | no | OK |
| outcome_symptom |
yes
yes
shaky reasoning✓ Unanimous
Initial: yes
|
yes
no → yes
shaky reasoning✓ Unanimous
Initial: no
Requery: yes — The secondary outcome measures health-related quality of life symptoms using EORTC symptom scales.
|
yes
no → yes
shaky reasoning✓ Unanimous
Initial: no
Requery: yes — The EORTC STO-22 secondary outcome specifically measures multiple symptoms including dysphagia, pain, upper gastro-esophageal symptoms, emotional problems/anxiety, and other gastric cancer-specific symptoms, making this a symptom assessment tool.
|
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 | immunotherapy | immunotherapy | immunotherapy | OK |