Patients scheduled to receive Alluminox treatment (photoimmunotherapy) for head and neck cancer.
Conditions
Interventions
1. The principal (sub) investigator will administer cetuximab sarotalocan sodium (genetic recombination) (trade name: Akalux) 640 mg/m2 intravenously to the patient over 2 hours on day -1.
2. The prin
Sponsors
Okada Ryuhei
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with unresectable locally advanced or locally recurrent head and neck cancer who are scheduled to undergo Alluminox treatment (Photoimmunotherapy) for head and neck cancer (regardless of whether they have had a history of Alluminox treatment for head and neck cancer) 2. Patients whose laser light illumination areas include the oropharynx, hypopharynx, or larynx. 3. Patients aged 18 years or older at the time of informed consent. 4. Patients who have given their written informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients after laryngectomy. 2. Patients whose larynx cannot be observed after treatment due to some reasons, such as anatomical reasons or tumors. 3. Patients who will be managed with transnasal or transoral intubation after treatment. 4. Patients with contraindications to Celecoxib or Flurbiprofen axetil. Patients with peptic ulcer Patients with serious blood disorders Patients with severe hepatic impairment Patients with severe renal dysfunction Patients with severe cardiac dysfunction Patients with severe hypertension Patients with aspirin asthma (asthma attack induced by NSAIDs or other drugs) or a history of aspirin asthma Periodic patients undergoing coronary artery bypass graft reconstruction (Cohort A) Patients with a history of hypersensitivity to any component of the drug or to sulfonamide (Cohort A) Patients receiving Enoxacin hydrate, Lomefloxacin, Norfloxacin, Prulifloxacin (Cohort B) 5. Patients with a history of hypersensitivity to any component of Cetuximab sarotalocan sodium (genetic recombination). 6. Patients with tumor invasion to the carotid artery. 7. Patients receiving NSAIDs for cancer pain or other comorbidities. 8. Patients on long-term systemic administration of steroids. 9. Patients receiving IL-6 inhibitors. 10. Patients who are pregnant, may be pregnant, or are lactating. 11. Patients who are judged as ineligible for registration by attending doctors. 12. Patients with laryngeal edema.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Degree of laryngeal edema 24 hours after laser light illumination (evaluated by laryngoscopy/central assessment) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Degree of laryngeal edema 24 hours after laser light illumination (evaluated by laryngoscopy/attending physician's assessment) 2. Changes over time in laryngeal edema 3. Level of pain (NRS) 4. Edema in areas other than the larynx 5. QOL(EORTC QLQ-C30+HN43) 6. Response Evaluation Criteria 7.Percentage of adverse events 8.Percentage of device malfunction | — |
Contacts
Public ContactRyuhei Okada
Institute of Science Tokyo Hospital
Outcome results
None listed