Status:
UNKNOWN
Docetaxel and S-1 Followed By Radiation Therapy and Low-Dose Cisplatin in Treating Patients With Stage III or Stage IV Head and Neck Cancer
Lead Sponsor:
Yonsei University
Conditions:
Head and Neck Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as docetaxel, S-1, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. R...
Detailed Description
OBJECTIVES: Primary * To assess the response rate in patients with stage III or IV head and neck cancer treated with induction therapy comprising docetaxel and S-1 followed by radiotherapy and low-d...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Pathologically confirmed head and neck cancer arising from the oral cavity, oropharynx, hypopharynx, or nasopharynx, including any of the following subtypes:
- Squamous cell carcinoma
- Poorly differentiated carcinoma
- Lymphoepithelioma
- Locally advanced disease (stage III or IV \[M0\] disease)
- At least 1 unidimensionally measurable index lesion
- PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- ANC ≥ 1,500/mm³
- Platelet count ≥ 100,000/mm³
- Hemoglobin ≥ 9 g/dL
- Bilirubin ≤ 1.5 times the upper limit of normal (ULN)
- Alkaline phosphatase ≤ 3.0 times ULN
- AST and ALT ≤ 3.0 times ULN
- Creatinine ≤ 1.5 times ULN
- No concurrent serious systemic disorder that, in the opinion of investigator, would compromise the patient's ability to complete the study
- No serious cardiac condition, including any of the following:
- Myocardial infarction within the past 6 months
- Angina
- NYHA class III-IV heart disease
- No active infection requiring IV antibiotics, including active tuberculosis or HIV
- No other malignancy within the past 5 years except basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix
- Able to comply with protocol or study procedures
- PRIOR CONCURRENT THERAPY:
- No prior radiotherapy or chemotherapy
Exclusion
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT00625937
Start Date
November 1 2006
Last Update
February 28 2011
Active Locations (1)
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1
Yonsei Cancer Center at Yonsei University Medical Center
Seoul, South Korea, 120-752