ECOG-ACRIN EA3132
Trial Overview
Official Title
Testing The Addition Of Chemotherapy Drug, Cisplatin, To Usual Radiation Therapy For Patients With Head And Neck Cancer
Study Purpose
To compare two treatment approaches currently used after surgery for head and neck cancer. One approach is to administer radiation therapy alone. A second approach is to administer radiation therapy along with the chemotherapy drug, cisplatin.
Diagnosis
Squamous cell carcinoma of the head/neck; Verrucous carcinoma of the head/neck; Spindle cell carcinoma of the head/neck; Carcinoma NOS of the head/neck (oral cavity, oropharynx, hypopharynx or larynx)Eligibility
Pathologic stage III or IVA
Has had surgery to remove the primary tumor
No chemotherapy within 2 years of surgical removal of tumor
Patients must sign an approved informed consent and authorization permitting release of personal health information.
Intervention
Before study initiation, a laboratory test to determine the genomic mutation of the TP53 gene is mandatory. This will be accomplished by testing small pieces of cancer tissue from prior surgery.
Group 1: Radiation therapy (usual approach group)
Group 2: Radiation therapy plus cisplatin (study group)
For more information, visit ClinicalTrials.gov