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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

Key Participation Requirements
Gender
Male or Female
Age
19 years and older
Enrollment Status
Recruiting
Phase
Phase II
Methodist Health System Trial Code
ECOG-ACRIN EA3132