Health Trials

Radiation Therapy With or Without Cisplatin in Treating Patients With Stage III-IVA Squamous Cell Carcinoma of the Head and Neck Who Have Undergone Surgery

ConditionsHead and Neck Squamous Cell CarcinomaHypopharyngeal Squamous Cell CarcinomaLaryngeal Squamous Cell CarcinomaLaryngeal Squamous Cell Carcinoma, Spindle Cell VariantLip and Oral Cavity Squamous Cell Carcinomap16INK4a Negative Oropharyngeal Squamous Cell CarcinomaStage III Hypopharyngeal Carcinoma AJCC v8Stage III Laryngeal Cancer AJCC v8Stage III Lip and Oral Cavity Cancer AJCC v8Stage III Oral Cavity Verrucous CarcinomaStage III Oropharyngeal (p16-Negative) Carcinoma AJCC v8Stage IVA Hypopharyngeal Carcinoma AJCC v8Stage IVA Laryngeal Cancer AJCC v8Stage IVA Lip and Oral Cavity Cancer AJCC v8Stage IVA Oral Cavity Verrucous CarcinomaStage IVA Oropharyngeal (p16-Negative) Carcinoma AJCC v8
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorECOG-ACRIN Cancer Research Group

About this trial

This phase II trial studies how well radiation therapy with or without cisplatin works in treating patients with stage III-IVA squamous cell carcinoma of the head and neck who have undergone surgery. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known if radiation therapy is more effective with or without cisplatin in treating patients with squamous cell carcinoma of the head and neck.

Eligibility criteria

Qualifiers

PRE-REGISTRATION (STEP 0)

Pathologically proven diagnosis of squamous cell carcinoma (including variants such as verrucous carcinoma, spindle cell carcinoma, carcinoma not otherwise specified [NOS]) of the head/neck (oral cavity, oropharynx, hypopharynx or larynx); pathologic stage III or IVA (American Joint Committee on Cancer [AJCC] 8): T3-T4a, N0-3, M0 or T1-T2, N1-3, M0

Patient has undergone total resection of the primary tumor with curative intent

NOTE: Patient is to be pre-registered to screening (Step 0) and tissue submitted to Foundation Medicine as soon as possible after surgery in order to meet the 8 week deadline to register the patient to Step 1 after surgery; full assay minimum turn-around time is 17-24 days

Disqualifiers

None

Trial design

Treatments tested in this trial

  • Cisplatin
  • Intensity-Modulated Radiation Therapy
  • Laboratory Biomarker Analysis

Treatment groups

189 Participants
are divided into 2 treatment groups

Locations

676
Alabama
University of Alabama at Birmingham Cancer Center35233, Birmingham United States
Alaska
Alaska Breast Care and Surgery LLC99508, Anchorage United States
Alaska Oncology and Hematology LLC99508, Anchorage United States
Alaska Women's Cancer Care99508, Anchorage United States

Sponsors and collaborators

ECOG-ACRIN Cancer Research Group

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov