Intensity-Modulated Proton Beam Therapy or Intensity-Modulated Photon Therapy in Treating Patients With Stage III-IVB Oropharyngeal Cancer

Stage IVA Oropharyngeal Squamous Cell Carcinoma AJCC v7 Clinical Trial

Official title: Phase II/III Randomized Trial of Intensity-Modulated Proton Beam Therapy (IMPT) Versus Intensity-Modulated Photon Therapy (IMRT) for the Treatment of Oropharyngeal Cancer of the Head and Neck

Status Active, not recruiting

Clinical Trial Summary

This randomized phase II/III trial studies the side effects and how well intensity-modulated proton beam therapy works and compares it to intensity-modulated photon therapy in treating patients with stage III-IVB oropharyngeal cancer. Radiation therapy uses high-energy x-rays, protons, and other types of radiation to kill tumor cells and shrink tumors. It is not yet known whether intensity-modulated proton beam therapy is more effective than intensity-modulated photon therapy in treating oropharyngeal cancer.

Clinical Trial Description

PRIMARY OBJECTIVES:

I. To compare the rates and severity of late grade 3-5 toxicity between intensity-modulated photon therapy (IMRT) and intensity-modulated proton therapy (IMPT) following the treatment of oropharyngeal tumors. (Phase II) II. To compare the rate of 3-year progression-free survival (PFS) between concurrent chemo-radiation strategies with IMRT and IMPT following the treatment of oropharyngeal tumors. (Phase III)

SECONDARY OBJECTIVES:

I. Disease-related outcomes (2-year progression-free survival, patterns of failure, 2-year overall survival, 2-year [yr] distant metastasis free survival, and second primary cancers). (Phase III) II. Patient Reported Outcome (PRO) measures of symptoms using MD Anderson Symptom Inventory (MDASI), MD Anderson Dysphagia Inventory (MDADI), Functional Assessment of Cancer Therapy-Head and Neck (FACT-HN), Xerostomia and Health Questionnaire (European Quality of Life 5-Dimension three level scale [EQ-5D-3L]), work status (Work Productivity and Activity Impairment: Specific Health Problem [WPAI: SHP]). (Phase III) III. Physician reported toxicity using Common Terminology Criteria for Adverse Events (CTCAE)-4.0. (Phase III) IV. Quality-Adjusted-Life-Years (QALY) comparison between IMPT and IMRT. (Phase III) V. Cost-benefit economic analysis of treatment. (Phase III) VI. To determine whether specific molecular profiles are associated with overall or progression-free survival. (Phase III) VII. To investigate associations between changes in serum biomarkers or human papillomavirus (HPV)-specific cellular immune responses measured at baseline and three months with overall or progression-free survival. (Phase III) VIII. To bank peripheral blood at time of enrollment, weeks 2, 4, and 6 during treatment and during follow up visits for 2 years to explore the ability of circulating markers to predict outcome. (Phase III) IX. To bank head and neck tissues to explore the ability of tissue-based markers to predict outcome. (Phase III) X. To bank peripheral blood and tissues for future interrogations. (Phase III) XI. Acute side effects of radiation therapy will be assessed. (Phase III)

EXPLORATORY OBJECTIVE:

I. To assess potential differences between patients on study and patients who were considered eligible for randomized, were randomized to a treatment arm, but were denied insurance coverage for the treatment arm she/he was randomized to; or may have dropped out of the study for other reasons after being randomized. These patients will compromise Group 3: consisting of patients randomized to Protons but not treated and Group 4: consisting of patients randomized to IMRT but not treated at the designated institution. Furthermore, these patients will only be followed for recurrence and survival.(Phase III)

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients undergo IMRT once daily (QD) five days a week for approximately 6.5 weeks.

ARM II: Patients undergo IMPT QD five days a week for approximately 6.5 weeks.

After completion of study treatment, patients are followed up every 3 months for 1 year, every 4 months for 1 year, and then every 6 months for 5 years. ;

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Oropharyngeal Neoplasms
• Squamous Cell Carcinoma of Head and Neck
• Stage III Oropharyngeal Squamous Cell Carcinoma AJCC v7
• Stage IVA Oropharyngeal Squamous Cell Carcinoma AJCC v7
• Stage IVB Oropharyngeal Squamous Cell Carcinoma AJCC v7

• NCT number: NCT01893307
• Study type: Interventional
• Source: M.D. Anderson Cancer Center
• Status: Active, not recruiting
• Phase: Phase 2/Phase 3
• Start date: August 26, 2013
• Completion date: August 31, 2025