| Protocol ID | NCT06326619 |
| Registration Date | 2024-03-22 |
| Status | completed |
| Sponsor | Medizinische Hochschule Brandenburg Theodor Fontane |
| Country | – |
| Industry | not industry |
| Blinding | unblinded |
| Center Type | – |
| Scope | – |
| First Patient In | 2012-01-01 |
| Last Patient Out | 2020-12-31 |
| Publication | n |
| Gender % | ALL |
| Mean Age | – |
NCT06326619
Survival Benefit of Palliative Primary Tumor Resection and Systemic Therapy Versus Systemic Therapy Only Among Patients With Stage IV Colorectal Carcinoma
| Field |
OPENAI
gpt-4o Thinking: o3 3610ms / 8923 tok |
CLAUDE
claude-sonnet-4-20250514 4915ms / 10387 tok |
GLM
glm-5.1 7154ms / 9088 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 → inpatient
shaky reasoning✗ No consensus
Initial: outpatient
Requery: outpatient — The intervention involves systemic therapy and scheduled primary tumor resection, which are typically administered in outpatient settings.
Thinking: inpatient — The intervention includes primary tumor resection, a procedure that necessitates hospital admission, and no outpatient delivery of care is explicitly described.
|
mixed |
mixed
mixed → mixed
shaky reasoning✗ No consensus
Initial: mixed
Requery: mixed — The study compares patients receiving primary tumor resection (requiring inpatient hospitalization) with patients receiving systemic therapy only (typically delivered in an outpatient setting), indicating that the study population includes both inpatient and outpatient care contexts.
|
|
| setting_place |
other
other → hospital → hospital
shaky reasoning✗ No consensus
Initial: other
Requery: hospital — The primary tumor resection as part of the intervention indicates the procedure occurs in a hospital setting with patients likely admitted for surgical operations.
Thinking: hospital — The key intervention is inpatient surgical resection of the primary colorectal tumor, which is necessarily delivered within a hospital setting.
|
other |
hospital
hospital → other
shaky reasoning✗ No consensus
Initial: hospital
Requery: other — This is a retrospective registry-based observational study that analyzes data from patients who received treatments across various settings (hospitals for resection, outpatient clinics for systemic therapy), making it a mixed or generic community setting.
|
|
| feasibility | N/A | N/A | N/A | 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 |
no
no → no
shaky reasoning✓ Unanimous
Initial: no
Requery: no — The trial compares systemic therapy alone to systemic therapy plus a surgical procedure, which is not considered a complex intervention according to the provided criteria.
|
yes |
no
yes → no
shaky reasoning✓ Unanimous
Initial: yes
Requery: no — The intervention combines surgical resection with systemic therapy (pharmacologic treatment), but the guidance explicitly states that combining surgical procedures does not qualify as a complex intervention.
|
– |
| intervention_acp | no | no | no | OK |
| intervention_music | no | no | no | OK |
| intervention_screening | no | no | no | OK |
| intervention_palliative | no | yes | no | – |
| intervention_education | no | no | no | OK |
| intervention_digital | no | no | no | OK |
| intervention_other |
no
no → no
shaky reasoning✓ Unanimous
Initial: no
Requery: no — The intervention includes systemic therapy, which fits under pharmacologic and chemo/immuno/radio categories.
|
yes |
no
yes → no
shaky reasoning✓ Unanimous
Initial: yes
Requery: no — The trial interventions consist of primary tumor resection (surgery/procedure) and systemic therapy (chemo/immuno), which fall outside the 'other' category.
|
– |
| outcome_symptom | no | no | no | OK |
| outcome_qol | no | no | no | OK |
| outcome_dignity | no | no | no | OK |
| outcome_cost | no | no | no | OK |
| outcome_other |
yes
no → yes
shaky reasoning✓ Unanimous
Initial: no
Requery: yes — The primary outcome of the study is survival, which is outside the categories of symptom/QoL/dignity/cost.
|
yes |
yes
yes
shaky reasoning✓ Unanimous
Initial: yes
|
OK |
| pharmacologic_sub | chemotherapy | chemotherapy | chemotherapy | OK |