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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

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Head and Neck Cancer Drug: cisplatin Drug: docetaxel Drug: fluorouracil Radiation: radiation therapy Phase 2

Detailed Description:


  • 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.

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Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : April 2003
Actual Primary Completion Date : November 2007

Resource links provided by the National Library of Medicine

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00054054

  Show 95 Study Locations
Sponsors and Collaborators
Southwest Oncology Group
National Cancer Institute (NCI)
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Study Chair: David J. Adelstein, MD The Cleveland Clinic

Publications of Results:
Adelstein DJ, Moon J, Hanna E, et al.: S0216: a Southwest Oncology Group (SWOG) phase II trial of docetaxel (T), cisplatin (P), and fluorouracil (F) induction followed by accelerated fractionation/concomitant boost (AF/CB) radiotherapy (RT) and concurrent cisplatin for advanced head and neck squamous cell cancer (HNSCC). [Abstract] J Clin Oncol 25 (Suppl 18): A-6014, 302s, 2007.

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Responsible Party: Laurence H. Baker, D.O., Southwest Oncology Group-Group Chair's Office Identifier: NCT00054054     History of Changes
Other Study ID Numbers: CDR0000269781
S0216 ( Other Identifier: SWOG )
U10CA032102 ( U.S. NIH Grant/Contract )
First Posted: February 6, 2003    Key Record Dates
Last Update Posted: July 25, 2011
Last Verified: July 2011
Keywords provided by Southwest Oncology Group:
stage III squamous cell carcinoma of the hypopharynx
stage III squamous cell carcinoma of the larynx
stage III squamous cell carcinoma of the oropharynx
stage IV squamous cell carcinoma of the hypopharynx
stage IV squamous cell carcinoma of the larynx
stage IV squamous cell carcinoma of the oropharynx
Additional relevant MeSH terms:
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Head and Neck Neoplasms
Neoplasms by Site
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs