Celecoxib Through Surgery and Radiation Therapy for the Treatment of Advanced Head and Neck Cancer
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Pathologic Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
- Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
- Clinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
- Stage IVA Oropharyngeal (p16-Negative) Carcinoma AJCC v8
- Stage III Laryngeal Cancer AJCC v8
- Stage IV Oropharyngeal (p16-Negative) Carcinoma AJCC v8
- Stage IVB Oropharyngeal (p16-Negative) Carcinoma AJCC v8
- Nasal Cavity and Paranasal Sinus Carcinoma
- Stage IV Hypopharyngeal Carcinoma AJCC v8
- Stage IVA Hypopharyngeal Carcinoma AJCC v8
- Stage IVA Laryngeal Cancer AJCC v8
- Oral Cavity Carcinoma
- Pathologic Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
- Recurrent Hypopharyngeal Carcinoma
- Recurrent Laryngeal Carcinoma
- Stage IVB Hypopharyngeal Carcinoma AJCC v8
- Stage IVC Laryngeal Cancer AJCC v8
- Stage III Hypopharyngeal Carcinoma AJCC v8
- Stage IVC Hypopharyngeal Carcinoma AJCC v8
- Recurrent Nasal Cavity and Paranasal Sinus Carcinoma
- Recurrent Oral Cavity Carcinoma
- Recurrent Oropharyngeal Carcinoma
- Stage IV Laryngeal Cancer AJCC v8
- Stage III Oropharyngeal (p16-Negative) Carcinoma AJCC v8
- Stage IVB Laryngeal Cancer AJCC v8
- Stage IVC Oropharyngeal (p16-Negative) Carcinoma AJCC v8
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Double (Participant, Investigator)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
PRIMARY OBJECTIVE: I. To assess the number of days from surgery to initiation of radiation and adjuvant therapy with the addition of celecoxib compared to placebo. SECONDARY OBJECTIVES: I. To assess overall pain control and management for patients on celecoxib compared to placebo. II. To assess func...
PRIMARY OBJECTIVE: I. To assess the number of days from surgery to initiation of radiation and adjuvant therapy with the addition of celecoxib compared to placebo. SECONDARY OBJECTIVES: I. To assess overall pain control and management for patients on celecoxib compared to placebo. II. To assess functional outcomes for patients on celecoxib compared to placebo. III. To assess the effect of celecoxib therapy on Quality of Life (QoL) compared to placebo. IV. To assess the average number of treatment days missed during adjuvant therapy for patients on celecoxib compared to placebo. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients receive celecoxib orally (PO) or via feeding tube twice daily (BID) starting 5 days prior to surgery and continues until the completion of radiation therapy (up to 6 months in total) in the absence of disease progression or unacceptable toxicity. ARM II: Patients receive placebo PO or via feeding tube BID starting 5 days prior to surgery and continues until the completion of radiation therapy (up to 6 months in total) in the absence of disease progression or unacceptable toxicity.
Tracking Information
- NCT #
- NCT04162873
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Principal Investigator: Richard Cannon, MD Huntsman Cancer Institute/ University of Utah