NCT06326619

Survival Benefit of Palliative Primary Tumor Resection and Systemic Therapy Versus Systemic Therapy Only Among Patients With Stage IV Colorectal Carcinoma

Extracted Fields (from Registry)
Protocol IDNCT06326619
Registration Date2024-03-22
Statuscompleted
SponsorMedizinische Hochschule Brandenburg Theodor Fontane
Country
Industrynot industry
Blindingunblinded
Center Type
Scope
First Patient In2012-01-01
Last Patient Out2020-12-31
Publicationn
Gender %ALL
Mean Age
LLM Classifications (Side-by-Side)
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
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