A Study to Evaluate Chemotherapy and Radiation Therapy With or Without Surgery to Treat Patients With Head and Neck Cancer

Overview

About this study

The purpose of this study is to determine whether intensification of radiation, relative to conventional fractionation plus cisplatin in the combined therapy setting can further improve the overall survival of patients with advanced HNSCC, to assess the actuarial local-regional control and disease-free rates of patients treated with the different regimens, to define the acute and late toxicity of each treatment regimen, to evaluate whether there are differences in patient’s QOL, perception of side effects, and performance status between treatment arms, to establish whether EGFR and COX-2 expressions are independent prognostic markers for patients receiving concurrent chemoradiation.

 

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. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Patients with histological proof (from the primary lesion and/or lymph nodes) of squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx.
  • Patients should have selected Stage III or IV disease (T2N2-3M0, T3-4 any N M0)
  • Patients must have Zubrod Performance Status of 0-1.
  • Histologically confirmed squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx.
  • Age ≥  18 years of age.
    1.  
  • Patients should have adequate bone marrow function defined as an absolute peripheral granulocyte count (AGC) of:
    • > 2000 cells/mm^3;
    • platelet count of > 100,000 cells/mm^3;
    • adequate hepatic function with bilirubin < 1.5 mg/dl;
    • AST or ALT < 2 x the upper limit of normal;
    • serum creatinine < 1.5 mg/dl, creatinine clearance > 50 ml/min;
    • normal serum calcium (or normal corrected serum calcium).
    • Formula for corrected calcium if albumin value is below normal range:
    • Corrected calcium (mg/dl) = [ 4 – [patient albumin (g/dl)] x 0.8 + patient calcium (mg/dl);
  • Creatinine clearance (CC) > 50 ml/min is determined by 24 hour collection or nomogram: 
    • CC male = (140 - age) x (wt. in kg)
      • Serum Cr mg/dl) x 72
    • CC female = 0.85 x (CC male)
  • No symptomatic coronary artery disease (angina) or history of myocardial infarction within the last 6 months; patients with symptomatic angina who are subsequently determined to be disease free are eligible.
  • Patients with a history of non-melanoma skin cancer, or other previous invasive malignancies from which the patient has remained continually disease free for > 3 years.

Exclusion Criteria:

    1.  
  • Histology other than squamous cell carcinoma.
  • Patients with T1-2N1 or T1N2-3.
  • Evidence of metastases (below the clavicle or distant) by clinical or radiographic examinations.
  • Prior chemotherapy for any reason or prior radiotherapy to the head and neck region except for radioactive iodine therapy.
  • Initial surgical treatment excluding diagnostic biopsy of the primary site or nodal sampling of neck disease; radical or modified neck dissection is not permitted.
  • Patients with simultaneous primaries.
  • Pregnant women because of the embryotoxic effects of chemotherapy.

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

More information

Publications

  • Tobacco smoking is associated with oropharynx cancer survival, but to what extent cancer progression or death increases with increasing tobacco exposure is unknown. Read More on PubMed

Additional contact information

Cancer-related trials contact form

Phone: 855-776-0015 (toll-free)

International patient clinical studies questions