Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Projected Accrual
Outline
Trial Contact Information

Alternate Title

Adjuvant Chemoradiotherapy Using Cisplatin and Docetaxel After Complete Resection in Treating Patients With Stage III or Stage IV Squamous Cell Carcinoma of the Head and Neck

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Approved-not yet active 18 and over NCI SWOG-S0217

Objectives

1. Determine the disease-free survival and overall survival of patients with high-risk stage III or IV squamous cell carcinoma of the head and neck treated with adjuvant chemoradiotherapy comprising docetaxel and cisplatin.
2. Determine the toxicity of this regimen in these patients.
3. Categorize the site(s) of disease relapse in patients treated with this regimen.

Entry Criteria

Disease Characteristics:

• Diagnosis of squamous cell carcinoma of the head and neck
  • Selected stage III or IV (no distant metastasis) disease
    • The following TNM stages are excluded:
      • T3, N0, M0
      • T4a, N0, M0
      • T4b, N3, M0
      • Any T, any N, M1



• Complete total resection within the past 56 days AND has one or more of the following risk factors:
  • Multiple pathologically confirmed lymph node metastases
  • One or more lymph nodes with extracapsular extension of tumor
  • Microscopically positive margin(s) of resection, including mucosal margins and/or soft tissue or deep margins of resection



• No primary nasopharyngeal carcinoma

Prior/Concurrent Therapy:

Biologic therapy

• Not specified

Chemotherapy

• No prior chemotherapy for the malignancy

Endocrine therapy

• Not specified

Radiotherapy

• No prior radiotherapy for the malignancy

Surgery

• See Disease Characteristics

Other

• No concurrent amifostine

Patient Characteristics:

Age

• 18 and over

Performance status

• Zubrod 0-1

Life expectancy

• Not specified

Hematopoietic

• Absolute neutrophil count ≥ 1,500/mm³
• Platelet count ≥ 100,000/mm³

Hepatic

• Bilirubin ≤ 2 times upper limit of normal (ULN)
• SGOT or SGPT ≤ 1.5 times ULN
• Alkaline phosphatase ≤ 2.5 times ULN

Renal

• Creatinine ≤ 1.5 mg/dL

  OR

• Creatinine clearance ≥ 60 mL/min

Other

• No pre-existing peripheral neuropathy
• No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer currently in complete remission
• Not pregnant or nursing
• Fertile patients must use effective contraception

Projected Accrual

A total of 70 patients will be accrued for this study within 17.5-23.5 months.

Outline

This is a multicenter study.

Patients receive docetaxel IV over 1 hour on days 1, 8, 15, 22, 29, and 36 and cisplatin IV over 1.5 hours on days 1, 22, and 43. Patients undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, 36-40, and 43-45. Treatment continues in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months until disease progression and then every 6 months for up to 3 years from registration.

Disclaimer

The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.

Trial Contact Information

Trial Lead Organizations

Southwest Oncology Group

Prakash Neupane, MD, Study coordinator		Ph: 660-829-7792
Harold Kim, MD, Study coordinator		Ph: 313-966-0556 Email: kimh@kci.wayne.edu
Stephen Williamson, MD, Study coordinator		Ph: 913-588-6029 Email: swilliam@kumc.edu
George Yoo, MD, Study coordinator		Ph: 313-745-4336; 800-527-6266 Email: gyoo@med.wayne.edu

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