Status:
UNKNOWN
S-1 or Tegafur-Uracil in Treating Patients With Previously Treated Stage III or Stage IV Head and Neck Cancer
Lead Sponsor:
Yokohama City University
Conditions:
Head and Neck Cancer
Eligibility:
All Genders
20-75 years
Phase:
PHASE3
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as S-1 and tegafur-uracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving S...
Detailed Description
OBJECTIVES: * Compare the disease-free survival rate in patients with definitively treated stage III or IV squamous cell carcinoma of the head and neck treated with adjuvant chemotherapy comprising S...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed squamous cell carcinoma of the head and neck (SCCHN)
- Stage III or IV disease
- Primary tumor in the mesopharynx, hypopharynx, larynx (except T3 N0 tumors of the glottis), oral cavity, or maxillary sinus
- Completed definitive treatment for SCCHN within the past 3 months, that included any of the following:
- Surgery
- Chemotherapy
- Biologic therapy
- Radiotherapy (e.g., radiotherapy in combination with chemotherapy or pre- or postoperative radiotherapy)
- Any other treatment
- No clinical evidence of locoregional tumors or distant metastasis within 3 months after the completion of definitive treatment
- PATIENT CHARACTERISTICS:
- ECOG performance status 0-1
- WBC ≥ 3,500/mm\^3 AND ≤ 12,000/mm\^3
- Neutrophil count ≥ 2,000/mm\^3
- Platelet count ≥ 100,000/mm\^3
- Hemoglobin ≥ 9 g/dL
- AST and ALT \< 100 IU/L
- Bilirubin \< 1.5 mg/dL
- Creatinine \< 1.2 mg/dL
- No uncontrolled cardiovascular disease
- No interstitial pneumonia or pulmonary fibrosis
- Must have sufficient oral intake
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No concurrent biologic therapy, radiotherapy, other chemotherapy, or any other therapy
Exclusion
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT00336947
Start Date
April 1 2006
Last Update
May 15 2013
Active Locations (48)
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1
Aichi Cancer Center
Nagoya, Aichi-ken, Japan, 464-8681
2
Fujita Health University
Toyoake, Aichi-ken, Japan, 470-11
3
Akita University Hospital
Akita, Akita, Japan, 010-854
4
Tokyo Dental College Ichikawa General Hospital
Ichikawa, Chiba, Japan, 272-8513