| Protocol ID | NCT06306638 |
| Registration Date | 2024-03-12 |
| Status | recruiting |
| Sponsor | Roswell Park Cancer Institute |
| Country | United States |
| Industry | not industry |
| Blinding | unblinded |
| Center Type | multicenter RCT |
| Scope | national RCT |
| First Patient In | 2024-10-01 |
| Last Patient Out | 2029-10-01 |
| Publication | n |
| Gender % | ALL |
| Mean Age | 18 Years - |
NCT06306638
A Phase I/II Study of Interstitial Photodynamic Therapy Following Palliative Radiotherapy for Patients With Inoperable Malignant Central Airway Obstruction
| 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 |