| Protocol ID | NCT01440088 |
| Registration Date | 2011-09-26 |
| Status | completed |
| Sponsor | Threshold Pharmaceuticals |
| Country | Austria, Belgium, Canada, Denmark, France, Germany, Hungary, Israel, Italy, Poland, Russia, Spain, United States |
| Industry | industry |
| Blinding | unblinded |
| Center Type | multicenter RCT |
| Scope | multinational RCT |
| First Patient In | 2011-09-01 |
| Last Patient Out | 2016-05-01 |
| Publication | n |
| Gender % | ALL |
| Mean Age | 15 Years - |
NCT01440088
A Randomized Phase 3, Multicenter, Open-Label Study Comparing TH-302 in Combination With Doxorubicin vs. Doxorubicin Alone in Subjects With Locally Advanced Unresectable or Metastatic Soft Tissue Sarcoma
| Field |
GLM
glm-5.1 9732ms / 9604 tok |
CLAUDE
claude-sonnet-4-20250514 5066ms / 11049 tok |
OPENAI
gpt-4o Thinking: o3 2868ms / 9432 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 multicenter Phase 3 trial delivers outpatient chemotherapy regimens (bolus injections or 48-96 hour infusions) to ambulatory cancer patients (ECOG 0-1) at clinical sites, typically managed in an outpatient or ambulatory clinic setting rather than requiring hospital admission.
|
other |
other
hospital → hospital → other
shaky reasoning✓ Unanimous
Initial: hospital
Requery: hospital — The trial involves administration of TH-302 and Doxorubicin via intravenous infusion, which suggests that the interventions are delivered in a hospital setting where such procedures are typically conducted.
Thinking: other — IV chemotherapy is administered in outpatient oncology infusion clinics across multiple centers without requiring hospital admission.
|
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
shaky reasoning✓ Unanimous
Initial: no
|
no |
no
yes → no
shaky reasoning✓ Unanimous
Initial: yes
Requery: no — The intervention involves a combination of two drugs, TH-302 and doxorubicin, which falls under a single pharmacologic intervention type.
|
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 |
not yet FDA/EMA approved
not yet FDA/EMA approved → not yet FDA/EMA approved
shaky reasoning✗ No consensus
Initial: not yet FDA/EMA approved
Requery: not yet FDA/EMA approved — TH-302 (evofosfamide) is an experimental hypoxia-activated prodrug that has not been approved by the FDA or EMA.
|
not yet FDA/EMA approved |
chemotherapy
chemotherapy → not yet FDA/EMA approved → chemotherapy
shaky reasoning✗ No consensus
Initial: chemotherapy
Requery: not yet FDA/EMA approved — TH-302 is an investigational hypoxia-activated prodrug not yet approved by FDA/EMA.
Thinking: chemotherapy — Both TH-302 (evofosfamide) and doxorubicin are cytotoxic anticancer agents administered systemically as chemotherapy.
|
|