Hypopharyngeal cancer
Conditions
Interventions
Investigation arm:adjuvant chemotherapy, Surgery and radiotherapy
control arm:Surgery and radiotherapy
Sponsors
Shanghai General Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Signed written informed consent; 2. Male or female aged 18 -75(including 18 and 75 years of age); 3. Pathology and imaging confirmed as hypopharyngeal squamous cell carcinoma; 4. The lesion(s) can be excised; 5. KPS score = 70 points; 6. Blood test: WBC = 2.0 × 10^9/L, PLT = 100 × 10^9/L, Hb > 10g/dl; 7. Serum biochemistry: serum total bilirubin =1.5×UNL, ASAT(SGOT)/ALAT(SGPT)=2.5×UNL, serum alkaline phosphatase =5×UNL, serum creatinine=120µmol/L(1.4mg/dl); if Cr >120 mol/L, creatinine clearance rate should be =60ml/min; 8. Survival is expected to be greater than 6 months; 9. Women of childbearing age (15~49 years) should be non-pregnancy during the trial (from 7 days before the treatment to 3 months after the chemotherapy); 10. The male patients with fertility must be agree to use effective contraceptive measures to avoid getting pregnant during the trial(from 7 days before the treatment to 3 months after the chemotherapy).
Exclusion criteria
Exclusion criteria: 1. Be confirmed as distant metastasis of the hypopharyngeal cancer, or with other malignant tumors; 2. Had surgical procedure for the primary tumor or lymph node; 3. Have been treated with radiotherapy for primary tumors or lymph nodes; 4. Have been treated with anti-tumor targeted therapy; 5. Have been treated with chemotherapy or immunotherapy of primary tumors; 6. Patients had malignant tumors in the past 5 years, except for healed skin basal cell carcinoma or cervical carcinoma in situ; 7. 3-4 level allergic reactions to any chemicals in the trail; 8. Peripheral neuropathy >1 grade; 9. With any unstable systemic diseases (including active infection, uncontrolled hypertension, unstable angina, within the last 3 months of the onset of angina, congestive heart failure, occurred in the group within 12 months prior to myocardial infarction, severe heart arrhythmia, need drug treatment liver, kidney or metabolic disease); 10. With human immunodeficiency virus (HIV) infection; 11. Chronic diseases requiring immune agents or hormone therapy; 12. Pregnant or lactating women; 13. Drug / alcohol abuse, or psychological or psychiatric disorders that may interfere with the study of compliance; 14. Epilepsy patients who require drug therapy (such as steroids or antiepileptic drugs); 15. Had other clinical trials in the past 30 days; 16. The investigator assessed the requirement that the patient was unable or unwilling to comply with the study protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| disease free survival(dfs);objective response rate (ORR);rate of endoscopic surgery; | — |
Secondary
| Measure | Time frame |
|---|---|
| pathological Complete Response (pCR);local control rate;Overall survival rate; | — |
Countries
China
Contacts
Public ContactDong Pin
Shanghai General Hospital
Outcome results
None listed