Neoplasms

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Symptoms and General Pathology

Respiratory Tract (Lung and Bronchial) Diseases

Ear, Nose, and Throat Diseases

Mouth and Tooth Diseases

Musculoskeletal Diseases

Rare Diseases

Carcinoma

Recurrence

Head and Neck Neoplasms

Laryngeal Neoplasms

Oropharyngeal Neoplasms

Paranasal Sinus Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Disease Attributes

Otorhinolaryngologic Neoplasms

Laryngeal Diseases

Respiratory Tract Diseases

Respiratory Tract Neoplasms

Otorhinolaryngologic Diseases

Pharyngeal Neoplasms

Pharyngeal Diseases

Stomatognathic Diseases

Nose Neoplasms

Nose Diseases

Paranasal Sinus Diseases

Laryngeal Cancer

Hypopharyngeal Cancer

All Drugs and Chemicals

Anti-Inflammatory Agents

Antirheumatic Agents

Analgesics

Pyrazole

Celecoxib

Anti-Inflammatory Agents, Non-Steroidal

Analgesics, Non-Narcotic

Cyclooxygenase 2 Inhibitors

Cyclooxygenase Inhibitors

Enzyme Inhibitors

Patients receive celecoxib PO or via feeding tube BID starting 1 to 7 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.

Patients receive placebo PO or via feeding tube BID starting 1 to 7 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.

Placebo

Quality-of-Life Assessment

Questionnaire Administration

Richard Cannon, MD

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.

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.

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.

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

RESILIENCE: Effect of Comprehensive Celecoxib Through Treatment for Advanced-Stage Head and Neck Cancer: A Randomized, Double-Blinded, Placebo-Controlled Trial

The day of surgery will be considered day 0 and the number of days will be counted until the first dose of adjuvant radiation. A Gaussian mixed effects regression model will be used to compare the average number of days from surgery to the initiation of radiation and adjuvant therapy between treatment and control groups. The model will contain fixed effects for treatment arm and provider and a nested random effect for patient within provider. The mean difference between treatment groups, two-sided p-value and 95% confidence interval will be calculated from the model.

Assessment of subjective pain scores on the visual analog scale of pain intensity averaged over a week at rest, with a swallow, and with a cough. Pain intensity scale is a range from 0-10. 0= No Pain, 5= Moderate pain, 10= Unbearable paining

Assessment of current activity level and swallowing capabilities, including food and liquid variety and assessment of G tube utilization.

Completion of quality of life questionnaire EORTC QLQ-H\&N43 as per the protocol described schedule.

Assess the number of treatment days missed or delayed during adjuvant radiation.

Narcotic consumption will be assessed in daily total morphine equivalents averaged over a week

Patient satisfaction will be assessed with pain control questionnaire.

Completion of quality of life questionnaire MDASI-HN as per the protocol described schedule.

National Cancer Institute (NCI)

University of Utah

Salvage surgery hopes to control the recurrence of larynx, pharynx, fistula and neck tumor and improve the quality of life and survival rate

salvage surgery

Genglong Liu

Early laryngeal cancer can be treatment by laser surgery or radiotherapy, intermediate and advanced laryngeal carcinoma mainly surgical treatment. Laryngeal cancer is at risk of recurrence after treatment, whether in surgery, laser or radiotherapy. The recurrence rate of laryngeal cancer is about 10% reported at home and abroad. Local pain, ulcers, breathing and eating difficulties caused by recurrent laryngeal cancer seriously reduce the quality of life of patients and seriously endanger their lives. Therefore, head and neck surgeons are required to make every effort to give them saving treatment in order to improve their quality of life. Prolong the patient's life.

medical records and extracted information including age, gender, initial treatment modality of glottis cancer, recurrence time, recurrence site, histopathology, tumor grade according to World Health Organization (WHO) grade and tumor stage. Stages were defined according to the American Joint Committee on Cancer (AJCC) staging system.

Analysis of the Curative Effect of Salvage Surgery on Recurrent Laryngeal Carcinoma

Analysis of the Curative Effect of Salvage Surgery on Recurrent Laryngeal Carcinoma: A Single-institutional Experience

The overall survival rate was calculated with Kaplan-Meier method.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Celecoxib Through Surgery and Radiation Therapy for the Treatment of Advanced Head and Neck Cancer	NCT04162873	Clinical Stage ... Clinical Stage ... Nasal Cavity an... Oral Cavity Car... Pathologic Stag... Pathologic Stag... Recurrent Hypop... Recurrent Laryn... Recurrent Nasal... Recurrent Oral ... Recurrent Oroph... Stage III Hypop... Stage III Laryn... Stage III Oroph... Stage IV Hypoph... Stage IV Laryng... Stage IV Oropha... Stage IVA Hypop... Stage IVA Laryn... Stage IVA Oroph... Stage IVB Hypop... Stage IVB Laryn... Stage IVB Oroph... Stage IVC Hypop... Stage IVC Laryn... Stage IVC Oroph...	Celecoxib Placebo Quality-of-Life... Questionnaire A...	18 Years -	University of Utah
Analysis of the Curative Effect of Salvage Surgery on Recurrent Laryngeal Carcinoma	NCT03604601	Recurrent Laryn...	salvage surgery	18 Years - 75 Years	First Affiliated Hospital, Sun Yat-Sen University
Analysis of the Curative Effect of Salvage Surgery on Recurrent Laryngeal Carcinoma	NCT03604601	Recurrent Laryn...	salvage surgery	18 Years - 75 Years	First Affiliated Hospital, Sun Yat-Sen University
Analysis of the Curative Effect of Salvage Surgery on Recurrent Laryngeal Carcinoma	NCT03604601	Recurrent Laryn...	salvage surgery	18 Years - 75 Years	First Affiliated Hospital, Sun Yat-Sen University

Spots Global Cancer Trial Database for recurrent laryngeal carcinoma