Hypopharyngeal cancer
Conditions
Interventions
Iv, administration of TXT (75mg/m2) and CDDP(75mg/m2) on day1. Continuous iv infusion of 5-FU (750mg/m2/day) from day 1 to day 5. 1cycle. 28 days. Equal to or more than 2 cycle (max 4cycles).
Sponsors
Department of Head and Neck Surgery, Saitama Medical University International Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Histologically confirmed squamous cell carcinoma of hypopharynx. 2) Stage III, and IV case. 3) The patient must have measurable disease (RECIST) 4) Any therapy should not have been given for the current disease. 5) Age 20 years or older 6) ECOG Performance Status 0-2 7) Patient must have appropriate organ function (bone marrow, liver, kidney, cardiac, etc.) and the laboratory value within 7 days before the protocol treatment must be WBC 4,000/mm3 or more ANC 2,000/mm3 or more Platelet 100,000/mm3 or more Hemoglobin 9.0g/dl or more AST, ALT x2 institutional ULN or less Serum Total Bilirubin 1.5 mg/dL or less Serum Creatinine 1.5 mg/dL or less Creatinine clearance 60 ml/min or more BUN 25mg/dl or less ECG Normal 8) Collected tissue sample with biopsy enough for genomic analysis. 9) Life expectancy must be 12 weeks or more. 10) Written informed consent must be obtained for the study including blood or tissue sampling.
Exclusion criteria
Exclusion criteria: Patients who did not meet the above mentioned inclusion criteria. 2) No distant metastases were existed when treatment was started. 3) Patients with severe hypersensitivities or drug allergy. 4) Patients with history of hypersensitivity reactions to polysorbate 80. 5) Patients with considerable cancerous body cavity fluid. 6) Patients with obvious infectious disease 7) Patients with watery diarrhea. 8) Patients with intestinal paralysis or obstruction. 9) Patients with severe aspiration, and high risk for aspiration pneumonia. 10) Patients with severe complications. (Examples: pulmonary fibrosis, interstitial pneumonia, tendency to bleed, active bleeding with necessity for frequent transfusion.) 11) Patients with peripheral (sensory or motor) neuropathy Grade 2 or greater. 12) Patients with edema Grade 2 or greater. 13) Patients with continuous administration of phenytoin, and warfarin potassium. 14) Patients with liver cirrhosis. 15) Patients with active double cancer. 16) Patients with uncontrollable diabetes 17) Patients with clinically serious cardiac disease. 18) Patients with clnically serious psycho-neurological disease for continuation therapy. 19) Patients who are pregnant or breast feeding or possibility of pregnancy 20) Patients whom investigators determined it impossible to complete the protocol treatment safely.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate (RECIST) | — |
Secondary
| Measure | Time frame |
|---|---|
| markers. | — |
Countries
Japan
Contacts
Public ContactMasashi Sugasawa
Saitama Medical University, International Medical Center Department of Head and Neck Surgery
Outcome results
None listed