S0216, Combination Chemotherapy and RT in Treating Patients With Stage III or Stage IV Head and Neck Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00054054
Recruitment Status : Completed
First Posted : February 6, 2003
Last Update Posted : July 25, 2011
National Cancer Institute (NCI)
Information provided by:
Southwest Oncology Group

February 5, 2003
February 6, 2003
July 25, 2011
April 2003
November 2007   (Final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00054054 on Archive Site
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S0216, Combination Chemotherapy and RT in Treating Patients With Stage III or Stage IV Head and Neck Cancer
Docetaxel (NSC-628503), Cisplatin (NSC-119875), And 5-Fluorouracil (NSC-19893) Induction Chemotherapy Followed By Accelerated Fractionation/Concomitant Boost Radiation And Concurrent Single Agent Cisplatin (NSC-119875), In Patients With Advanced Squamous Cell Head And Neck Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining more than one chemotherapy drug with radiation therapy may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy and radiation therapy in treating patients with stage III or stage IV head and neck cancer.


  • Determine the overall survival of patients with stage III or IV squamous cell head and neck cancer treated with docetaxel, cisplatin, and fluorouracil followed by accelerated fractionation/concomitant boost radiotherapy and cisplatin.
  • Determine the unconfirmed complete response rate in these patients after treatment with induction chemotherapy.
  • Determine the overall complete response rate (confirmed and unconfirmed) in patients treated with this regimen.
  • Determine the toxic effects of this regimen in these patients.


  • Induction Chemotherapy: Patients receive docetaxel IV over 1 hour and cisplatin IV over 30-60 minutes on day 1 and fluorouracil IV continuously on days 1-4. Treatment repeats every 21 days for 2 courses in the absence of unacceptable toxicity.
  • Chemoradiotherapy: Beginning within 3-4 weeks after administration of the second course of induction chemotherapy, patients receive accelerated fractionation radiotherapy once daily, 5 days per week, for 6 weeks with concomitant boost radiotherapy once daily, 5 days a week, for the last 2.5 weeks of radiotherapy. Patients also receive concurrent cisplatin IV over 30-60 minutes on days 1 and 22.

Patients are followed every 2 months for 1 year, every 3 months for 2 years, every 4 months for 1 year, and then every 6 months for 1 year.

PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study within 2 years.

Phase 2
Primary Purpose: Treatment
Head and Neck Cancer
  • Drug: cisplatin
  • Drug: docetaxel
  • Drug: fluorouracil
  • Radiation: radiation therapy
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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November 2007   (Final data collection date for primary outcome measure)


  • Histologically confirmed squamous cell carcinoma of the head and neck (excluding lip, nasopharynx, paranasal sinus, and salivary gland) by biopsy or fine needle aspirate of the primary lesion or neck mass

    • Stage III or IV disease
  • No evidence of distant metastases

    • Negative chest x-ray
  • Primary site in the head and neck region must be identified

    • No unknown primary site
  • Considered to be appropriate for definitive radiotherapy with curative intent



  • 18 and over

Performance status

  • Zubrod 0-1

Life expectancy

  • Not specified


  • Granulocyte count greater than 1,500/mm^3
  • Platelet count greater than 100,000/mm^3


  • Bilirubin no greater than upper limit of normal (ULN)
  • Alkaline phosphatase less than 2 times ULN
  • ALT or AST less than 1.5 times ULN


  • Creatinine less than 1.5 mg/dL


  • No myocardial infarction within the past 3 months
  • No unstable or uncontrolled angina


  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No other prior 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
  • No evidence of pre-existing peripheral neuropathy
  • No active systemic infection
  • No history of hypersensitivity reaction to products containing polysorbate 80


Biologic therapy

  • Not specified


  • No prior chemotherapy

Endocrine therapy

  • Not specified


  • See Disease Characteristics
  • No prior radiotherapy


  • No prior surgery for head or neck cancer
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
Canada,   United States
S0216 ( Other Identifier: SWOG )
U10CA032102 ( U.S. NIH Grant/Contract )
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Laurence H. Baker, D.O., Southwest Oncology Group-Group Chair's Office
Southwest Oncology Group
National Cancer Institute (NCI)
Study Chair: David J. Adelstein, MD The Cleveland Clinic
Southwest Oncology Group
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP