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

Overview

About this study

This phase II trial studies how well radiation therapy with or without cisplatin works in treating patients with stage III-IV 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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Please contact the study team to discuss whether or not you are eligible to participate in a study.

Inclusion Criteria:

  • 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); clinical stage T2-T4a, N0-2, M0 or T1, N1-2, M0
  • Patient has undergone total resection of the primary tumor with curative intent
  • Patient must have negative human papillomavirus (HPV) status of the tumor as determined by p16 protein expression using immunohistochemistry (IHC)
  • The patient must have the following assessments done within 80 days prior to randomization:
    • Examination by an Ear, Nose, and Throat (ENT)/Head & Neck Surgeon
    • Neck computed tomography (CT) scan (from skull base to clavicle) and
    • Chest x-ray (or chest CT scan or CT/positron emission tomography [PET] of the chest) to rule out distant metastatic disease
  • Patients with, per the operative and/or pathology report, positive margin(s) (tumor present at the cut or inked edge of the tumor), nodal extracapsular extension, and/or gross residual disease after surgery are not eligible
  • A paraffin-embedded surgical tumor tissue specimen has been located is available for shipment to Foundation Medicine, Inc. following pre-registration
  • Patients with a history of a curatively treated malignancy must be disease-free for at least two years except for carcinoma in situ of cervix and/or non-melanomatous skin cancer
  • Patient must not have had previous irradiation to the head and neck that would result in overlap in radiation fields for the current disease
  • RANDOMIZATION (STEP 1)
  • Per the operative report, the gross total resection of the primary tumor with curative intent was completed within 7 weeks prior to randomization
  • Patient has Eastern Cooperative Oncology Group (ECOG) performance status 0-1 within 2 weeks prior to randomization
  • Women must not be pregnant or breast-feeding; females of childbearing potential must have a blood or urine study within 2 weeks prior to randomization to rule out pregnancy; a female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)
  • Women of childbearing potential and sexually active males must be strongly advised to use an accepted and effective method of contraception or to abstain from sexual intercourse for the duration of their participation in the study
  • Absolute neutrophil count >= 1,500/mm^3
  • Platelets >= 100,000/mm^3
  • Total bilirubin =< the upper limit of normal (ULN)
  • Calculated creatinine clearance must be > 60 ml/min using the Cockcroft-Gault formula
  • Patient must not have an intercurrent illness likely to interfere with protocol therapy

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Katharine Price, M.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

Mankato, Minn.

Mayo Clinic principal investigator

Katharine Price, M.D.

Contact us for the latest status

Contact information:

Ron Smith M.D.

(507)385-2929

Smith.Ron@mayo.edu

Albert Lea, Minn.

Mayo Clinic principal investigator

Katharine Price, M.D.

Contact us for the latest status

Contact information:

Timothy Kozelsky M.D.

(507)383-3509

kozelsky.timothy@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20336945

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