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Terminated PHASE2 INTERVENTIONAL NCT04162873

Celecoxib Through Surgery and Radiation Therapy for the Treatment of Advanced Head and Neck Cancer

View on ClinicalTrials.gov Updated Dec 15, 2025

Brief 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.

Detailed Description

PRIMARY OBJECTIVE: I. To assess the number of days from surgery to initiation of radiation 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. * Subjective pain scores on the visual analog scale of pain intensity averaged over a week at rest, with a swallow, and with a cough. * Patient satisfaction with pain control questionnaire. * Narcotic consumption in daily total morphine equivalents averaged over a week. 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 radiation 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.

Interventions

Name: Celecoxib
Type: DRUG
Description: Given PO or via feeding tube
Name: Placebo
Type: OTHER
Description: Given PO or via feeding tube
Name: Quality-of-Life Assessment
Type: OTHER
Description: Ancillary studies
Name: Questionnaire Administration
Type: OTHER
Description: Ancillary studies

Primary Outcomes

Measure: The Number of Days From Surgery to the Initiation of Radiation and Adjuvant Therapy
TimeFrame: up to 3 months
Description: The day of surgery will be considered day 0 and the number of days will be counted until the first dose of adjuvant radiation. This outcome measure will report the mean number of days from surgery to the initiation of radiation and adjuvant therapy for the Celecoxib and Placebo Arms.

Trial Information

NCT ID

NCT04162873

Status

Terminated

Study Type

INTERVENTIONAL

Phases

PHASE2

Sponsor

University of Utah

Last Updated

December 15, 2025