NCT01245582

A Randomized Phase III Study of Oxaliplatin (Eloxatin) and Capecitabine on Top of Sorafenib Versus Sorafenib Alone as First-line Palliative Treatment in Advanced Hepatocellular Carcinoma Patients

Extracted Fields (from Registry)
Protocol IDNCT01245582
Registration Date2010-11-22
StatusWithdrawn
SponsorSanofi
Country
Industryindustry
Blindingunblinded
Center Type
Scope
First Patient In2011-07-01
Last Patient Out2015-08-01
Publicationn
Gender %ALL
Mean Age18 Years - 75 Years
LLM Classifications (Side-by-Side)
Field GLM
glm-5.1
6450ms / 9237 tok
CLAUDE
claude-sonnet-4-20250514
9441ms / 10573 tok
OPENAI
gpt-4o
4209ms / 9071 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 a palliative oncology trial with an infusion delivered every 2 weeks; this treatment cycle typically takes place in an outpatient clinic or ambulatory day hospital setting rather than requiring inpatient hospital admission.
other other → other
shaky reasoning
✓ Unanimous Initial: other Requery: other — This is an outpatient oncology treatment study where patients receive oral medications at home and periodic intravenous infusions at outpatient clinics, not requiring hospitalization.
other hospital → other
shaky reasoning
✓ Unanimous Initial: hospital Requery: other — The trial involves drug delivery through both oral and intravenous routes, with no specific mention of hospitalization or home care, suggesting an outpatient or clinic-based setting.
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
shaky reasoning
✓ Unanimous Initial: no Requery: no — The intervention is a single-modality pharmacologic treatment combining multiple chemotherapy drugs (oxaliplatin, capecitabine, and sorafenib) without components from different categories such as behavioral or educational interventions.
no no → no
shaky reasoning
✓ Unanimous Initial: no Requery: no — This is a pharmacologic intervention comparing a combination of three anticancer drugs (oxaliplatin, capecitabine, sorafenib) versus sorafenib alone, which represents a single intervention type despite using multiple medications.
no yes → no
shaky reasoning
✓ Unanimous Initial: yes Requery: no — The trial involves combining pharmacologic agents only (oxaliplatin, capecitabine, sorafenib), which are different drugs but all within the same pharmacologic category.
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 no no no OK
outcome_dignity no no no OK
outcome_cost no no no OK
outcome_other yes yes yes OK
pharmacologic_sub chemotherapy chemotherapy chemotherapy OK
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