NCT06306638

A Phase I/II Study of Interstitial Photodynamic Therapy Following Palliative Radiotherapy for Patients With Inoperable Malignant Central Airway Obstruction

Extracted Fields (from Registry)
Protocol IDNCT06306638
Registration Date2024-03-12
Statusrecruiting
SponsorRoswell Park Cancer Institute
CountryUnited States
Industrynot industry
Blindingunblinded
Center Typemulticenter RCT
Scopenational RCT
First Patient In2024-10-01
Last Patient Out2029-10-01
Publicationn
Gender %ALL
Mean Age18 Years -
LLM Classifications (Side-by-Side)
Field OPENAI
gpt-4o
Thinking: o3
3452ms / 10183 tok
CLAUDE
claude-sonnet-4-20250514
Thinking: claude-opus-4-20250514
5176ms / 11840 tok
GLM
glm-5.1
8167ms / 10357 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 inpatient → outpatient
shaky reasoning
✓ Unanimous Initial: inpatient Requery: outpatient — The study describes interventions such as photodynamic therapy and palliative radiotherapy which are typically delivered on an outpatient basis, and there is no mention of patients being admitted or hospitalized for the duration of the treatment.
outpatient inpatient → outpatient
shaky reasoning
✓ Unanimous Initial: inpatient Requery: outpatient — The study involves bronchoscopic procedures, radiation therapy sessions, and photodynamic therapy treatments that are typically performed as outpatient procedures where patients receive treatment and then go home.
outpatient outpatient → outpatient
shaky reasoning
✓ Unanimous Initial: outpatient Requery: outpatient — The trial involves bronchoscopic procedures and palliative radiotherapy with follow-up visits at specific intervals, indicating patients return home after treatments rather than being continuously hospitalized.
OK
setting_place hospital hospital hospital 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 yes yes yes OK
intervention_psychological no no no OK
intervention_complex yes yes yes OK
intervention_acp no no no OK
intervention_music no no no OK
intervention_screening no no no OK
intervention_palliative no no → no
shaky reasoning
✓ Unanimous Initial: no Requery: no — The intervention is testing interstitial photodynamic therapy following palliative radiotherapy, not a palliative care service or consultation.
no yes → no
shaky reasoning
✓ Unanimous Initial: yes Requery: no — The intervention being tested is interstitial photodynamic therapy (I-PDT) with endobronchial ultrasound following radiotherapy - palliative radiotherapy is used as a standard component but the experimental intervention is the photodynamic therapy technique, not palliative care itself.
no no
shaky reasoning
✓ Unanimous Initial: 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 yes yes yes OK
outcome_dignity no no no OK
outcome_cost no no no OK
outcome_other yes yes yes OK
pharmacologic_sub off label use other → other → off label use
shaky reasoning
✓ Unanimous Initial: other Requery: other — Visudyne, a photosensitizer used in photodynamic therapy, is a pharmacologic intervention that does not fit in the specified categories such as controlled substances, chemotherapy, or immunotherapy. Thinking: off label use — Verteporfin is an FDA-approved photosensitizer for macular degeneration but is being used here for airway tumor treatment, a non-approved indication.
off label use other → other → off label use
shaky reasoning
✓ Unanimous Initial: other Requery: other — The study uses verteporfin (visudyne), a photosensitizer drug that is FDA-approved but represents a specialized pharmacologic intervention for photodynamic therapy rather than fitting into the specific categories like controlled substances, chemotherapy, or immunotherapy. Thinking: off label use — Verteporfin (Visudyne) is FDA-approved for macular degeneration but is being used here for cancer treatment via photodynamic therapy.
off label use not yet FDA/EMA approved → not yet FDA/EMA approved
shaky reasoning
✓ Unanimous Initial: not yet FDA/EMA approved Requery: not yet FDA/EMA approved — Verteporfin is being used as an investigational photosensitizer in combination with interstitial photodynamic therapy for malignant central airway obstruction, which is an experimental application.
OK
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