NCT00571740

Randomized Phase II Trial of Cetuximab/Bevacizumab (CB) as Palliative First-Line Therapy in Patients With Advanced Colorectal Cancer Followed by FOLFOX+CB vs. FOLFOX+B

Extracted Fields (from Registry)
Protocol IDNCT00571740
Registration Date2007-12-12
StatusWithdrawn
SponsorAlliance for Clinical Trials in Oncology
Country
Industrynot industry
Blindingunblinded
Center Type
Scope
First Patient In
Last Patient Out
Publicationn
Gender %ALL
Mean Age18 Years -
LLM Classifications (Side-by-Side)
Field OPENAI
gpt-4o
4408ms / 9665 tok
GLM
glm-5.1
7962ms / 9860 tok
CLAUDE
claude-sonnet-4-20250514
7662ms / 11323 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 hospital → other
shaky reasoning
✓ Unanimous Initial: hospital Requery: other — The trial is a multicenter study with treatments involving intravenous administration of drugs, likely in outpatient or community settings, but not requiring hospital admission.
other other
shaky reasoning
✓ Unanimous Initial: other
other other → other
shaky reasoning
✓ Unanimous Initial: other Requery: other — The study involves IV infusion treatments (bevacizumab, cetuximab, FOLFOX chemotherapy) that are typically administered in outpatient oncology clinics or infusion 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 no no no 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
shaky reasoning
✓ Unanimous Initial: no Requery: no — The clinical trial does not list any symptom measures as primary or secondary outcomes using validated instruments or direct symptom assessment.
no yes → no
shaky reasoning
✓ Unanimous Initial: yes Requery: no — The study measures quality of life using the UNISCALE, Skindex-16, and Skin Assessment Questionnaires, but does not use specific validated symptom instruments like ESAS, MSAS, or scales for pain, nausea, or fatigue.
no no → no
shaky reasoning
✓ Unanimous Initial: no Requery: no — The trial measures quality of life using UNISCALE and Skindex-16 questionnaires rather than specific symptom assessment instruments, and focuses on oncological endpoints like progression-free survival and tumor response.
OK
outcome_qol yes yes yes OK
outcome_dignity no no no OK
outcome_cost yes yes yes OK
outcome_other yes yes yes OK
pharmacologic_sub immunotherapy off label use → immunotherapy
shaky reasoning
✓ Unanimous Initial: off label use Requery: immunotherapy — Cetuximab and bevacizumab are monoclonal antibodies used in cancer treatment, classifying them under immunotherapy.
immunotherapy chemotherapy → immunotherapy
shaky reasoning
✓ Unanimous Initial: chemotherapy Requery: immunotherapy — The trial utilizes monoclonal antibodies (cetuximab and bevacizumab) for cancer treatment, which falls under the immunotherapy category.
immunotherapy chemotherapy → immunotherapy
shaky reasoning
✓ Unanimous Initial: chemotherapy Requery: immunotherapy — This trial uses monoclonal antibodies (cetuximab and bevacizumab) for cancer treatment, which are classified as immunotherapy interventions.
OK
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