Celecoxib Through Surgery and Radiation Therapy for the Treatment of Advanced Head and Neck Cancer
NCT04162873 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 13
Last updated 2025-02-12
Summary
This phase II trial studies how well celecoxib works through surgery and radiation therapy in treating patients with head and neck cancer that has spread to other places in the body (advanced). Celecoxib is Food and Drug Administration approved to treat arthritis, acute pain, and painful menstrual periods. Adding celecoxib to standard of care treatment may help to decrease the amount of time between surgery and radiation therapy.
Conditions
- Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
- Clinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
- Nasal Cavity and Paranasal Sinus Carcinoma
- Oral Cavity Carcinoma
- Pathologic Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
- Pathologic Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
- Recurrent Hypopharyngeal Carcinoma
- Recurrent Laryngeal Carcinoma
- Recurrent Nasal Cavity and Paranasal Sinus Carcinoma
- Recurrent Oral Cavity Carcinoma
- Recurrent Oropharyngeal Carcinoma
- Stage III Hypopharyngeal Carcinoma AJCC v8
- Stage III Laryngeal Cancer AJCC v8
- Stage III Oropharyngeal (p16-Negative) Carcinoma AJCC v8
- Stage IV Hypopharyngeal Carcinoma AJCC v8
- Stage IV Laryngeal Cancer AJCC v8
- Stage IV Oropharyngeal (p16-Negative) Carcinoma AJCC v8
- Stage IVA Hypopharyngeal Carcinoma AJCC v8
- Stage IVA Laryngeal Cancer AJCC v8
- Stage IVA Oropharyngeal (p16-Negative) Carcinoma AJCC v8
- Stage IVB Hypopharyngeal Carcinoma AJCC v8
- Stage IVB Laryngeal Cancer AJCC v8
- Stage IVB Oropharyngeal (p16-Negative) Carcinoma AJCC v8
- Stage IVC Hypopharyngeal Carcinoma AJCC v8
- Stage IVC Laryngeal Cancer AJCC v8
- Stage IVC Oropharyngeal (p16-Negative) Carcinoma AJCC v8
Interventions
- DRUG
-
Celecoxib
Given PO or via feeding tube
- OTHER
-
Placebo
Given PO or via feeding tube
- OTHER
-
Quality-of-Life Assessment
Ancillary studies
- OTHER
-
Questionnaire Administration
Ancillary studies
Sponsors & Collaborators
-
National Cancer Institute (NCI)
collaborator NIH - lead OTHER
Principal Investigators
-
Richard Cannon, MD · Huntsman Cancer Institute/ University of Utah
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-11-27
- Primary Completion
- 2023-02-28
- Completion
- 2023-04-26
- FDA Drug
- Yes
Countries
- United States
Study Locations
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