| Protocol ID | NCT03544736 |
| Registration Date | 2018-06-04 |
| Status | active, not recruiting |
| Sponsor | Oslo University Hospital |
| Country | Norway |
| Industry | not industry |
| Blinding | unblinded |
| Center Type | singel-center RCT |
| Scope | national RCT |
| First Patient In | 2018-04-26 |
| Last Patient Out | 2040-12-31 |
| Publication | n |
| Gender % | ALL |
| Mean Age | 18 Years - |
NCT03544736
Safety and Feasibility of Irradiation and Nivolumab in Esophageal Cancer (INEC-study) - a Phase I/II Trial
| Field |
GLM
glm-5.1 9020ms / 10204 tok |
CLAUDE
claude-sonnet-4-20250514 7384ms / 11739 tok |
OPENAI
gpt-4o 3100ms / 10013 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 | feasibility RCT | feasibility RCT | feasibility 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
no
shaky reasoning✓ Unanimous
Initial: no
|
yes
yes → yes
shaky reasoning✓ Unanimous
Initial: yes
Requery: yes — The intervention combines multiple distinct treatment modalities (immunotherapy with nivolumab, radiotherapy, chemotherapy, and surgery) that interact together as an integrated multicomponent treatment approach for esophageal cancer.
|
yes
yes → yes
shaky reasoning✓ Unanimous
Initial: yes
Requery: yes — The intervention combines different types, specifically pharmacological (Nivolumab) with radiotherapy and chemotherapy, integrating these distinct components across multiple cohorts.
|
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 | no | no | no | 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 |