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Status:

WITHDRAWN

S0217, Adjuvant Cisplatin and Docetaxel After Complete Resection Stage III or IV Head and Neck Cancer

Lead Sponsor:

SWOG Cancer Research Network

Collaborating Sponsors:

National Cancer Institute (NCI)

Conditions:

Head and Neck Cancer

Eligibility:

All Genders

18+ years

Phase:

PHASE2

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as cisplatin and docetaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays ...

Detailed Description

OBJECTIVES: * 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 ...

Eligibility Criteria

Inclusion

  • 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
  • PATIENT CHARACTERISTICS:
  • Age
  • 18 and over
  • Performance status
  • Zubrod 0-1
  • Life expectancy
  • Not specified
  • Hematopoietic
  • Absolute neutrophil count ≥ 1,500/mm\^3
  • Platelet count ≥ 100,000/mm\^3
  • Hemoglobin ≥ 8.0 g/dL
  • 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 known history of severe hypersensitiviy reaction to products containing Polysorbate 80
  • 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
  • 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

Exclusion

    Key Trial Info

    Start Date :

    July 1 2005

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    January 1 2007

    Estimated Enrollment :

    Patients enrolled

    Trial Details

    Trial ID

    NCT00084435

    Start Date

    July 1 2005

    End Date

    January 1 2007

    Last Update

    June 14 2012

    Active Locations (29)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 8 (29 locations)

    1

    USC/Norris Comprehensive Cancer Center and Hospital

    Los Angeles, California, United States, 90089-9181

    2

    Decatur Memorial Hospital Cancer Care Institute

    Decatur, Illinois, United States, 62526

    3

    Regional Cancer Center at Memorial Medical Center

    Springfield, Illinois, United States, 62781-0001

    4

    Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center

    Kansas City, Kansas, United States, 66160-7357