Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information
Docetaxel and Radiation Therapy in Treating Patients With Stage II or Stage III Cancer of the Larynx or Hypopharynx
| Phase | Type | Status | Age | Sponsor | Protocol IDs |
|---|---|---|---|---|---|
| Phase II | Treatment | Completed | Not specified | Other | AICHI-UHA-HN04-02 NCT00243113 |
Objectives
Primary
- Determine the objective response of the primary tumor in patients with stage II or III squamous cell carcinoma of the larynx or hypopharynx treated with docetaxel and radiotherapy.
Secondary
- Determine the local relapse-free survival of patients treated with this regimen.
- Determine the larynx-preservation survival of patients treated with this regimen.
- Determine the overall survival of patients treated with this regimen.
- Determine the protocol completion rate in patients treated with this regimen.
- Determine the adverse effects of this regimen in these patients.
Entry Criteria
Disease Characteristics:
- Histologically confirmed squamous cell carcinoma of the larynx or hypopharynx
- Stage II or III disease
- Solitary lymph node metastasis located in level II-III allowed
- Age 70 and over OR meets 1 of the following criteria:
- Creatinine clearance 30-60 mL/min
- History of platinum allergy
- Diagnosis of unstable angina
- Ineligible for systemic chemotherapy, including high-dose platinum-containing regimens
Prior/Concurrent Therapy:
Biologic therapy
- Not specified
Chemotherapy
- No prior systemic chemotherapy
Endocrine therapy
- Not specified
Radiotherapy
- No prior radiotherapy
Surgery
- No prior surgery
Patient Characteristics:
Age
- See Disease Characteristics
Performance status
- ECOG 0-2
Life expectancy
- Not specified
Hematopoietic
- WBC > 3,000/mm3
- Neutrophil count > 1,500/mm3
- Hemoglobin > 10 g/dL
- Platelet count > 100,000/mm3
Hepatic
- AST and ALT ≤ 2.0 times upper limit of normal
- Bilirubin < 2.0 mg/dL
- No severe liver disease
Renal
- See Disease Characteristics
- Creatinine clearance ≥ 30 mL/min
- No severe renal disease
Pulmonary
- No severe pulmonary disease
Other
- No severe neurologic disease
Expected Enrollment
50A total of 25-50 patients will be accrued for this study.
Outcomes
Primary Outcome(s)Objective response of primary tumor
Local complete response rate
Local progression-free survival at 2 years
Local relapse-free survival
Larynx preservation survival at 2 years
Overall survival at 2 years
Treatment completion rate
Incidence of adverse effects
Outline
This is a multicenter study.
Patients receive docetaxel IV over 1 hour on days 1, 8, 15, 22, and 29 and undergo radiotherapy on days 1-5, 8-12, 15-19, 22-26, and 29-33.
Trial Lead Organizations
Aichi Cancer Center
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| Nobukazu Fuwa, Protocol chair | |
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| Registry Information | ||
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| Official Title | Multi-Institutional Phase II Study of Weekly Docetaxel and Concurrent Radiotherapy for Laryngeal and Hypopharyngeal Cancer in the Group of Elderly and/or Patients With Medical Illness | |
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| Trial Start Date | 2004-06-01 | |
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| Trial Completion Date | 2008-03-31 | |
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| Registered in ClinicalTrials.gov | NCT00243113 | |
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| Date Submitted to PDQ | 2005-06-28 | |
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| Information Last Verified | 2008-03-30 | |
Note: 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.
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