hypopharyngeal squamous cell carcinoma
Conditions
Interventions
concurrent chemoradiotherapy:definitive concurrent chemoradiotherapy
Surgery group:definitive surgery
Sponsors
The Comprehensive Cancer Centre of Drum Tower Hospital, Medical School of Nanjing University &Clinical Cancer Institute of Nanjing University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. age (18 y/o-75 y/o) 2. cytologically or histologically confirmed hypopharyngeal squamous cell carcinoma 3. Imaging measurable lesions, TNM stage is T3 or T4a, Nx, M0 4. tumor tissues for gene expression tests 5. ECOG score =2 6. did not receive radiotherapy, chemotherapy or other anti-tumor drugs 7. CBC meets the below criteria: neutrophil count =1.5×10^9/L, hemoglobin =10g/dL, platelet count =100×10^9/L; 8. Blood chemistry meets the below criteria: total bilirubin =1.5×ULN, AST and ALT<1.5×ULN, Ccr =60ml/min; 9. The subjects of childbearing age were required to take appropriate protective measures (contraceptive measures or other methods of birth control) before and during the trial; 10. An informed consent has been signed; 11. Ability to follow research programmes and follow-up processes.
Exclusion criteria
Exclusion criteria: 1. received chemotherapy in the past 6 months before enrollment; 2. distant metastasis or metastases; 3. Subjects had a history of other cancers at the same time or in the past; 4. Subjects with active bacterial, viral or fungal infections (grade =2 of NCI-CTC, 3rd edition); 5. Subjects with severe hepatorenal dysfunction, HIV infection, HCV infection, uncontrolled coronary artery disease or asthma, uncontrolled diabetes, uncontrolled cerebrovascular disease, or other diseases that researchers consider to be unappropriate to be enrolled; 6. Pregnant and lactating women. Women of childbearing age must be pregnancy negative within 7 days before enrollment; 7. Drug abuse, clinical or psychological or social factors that affect the implementation of informed consent or research; 8. may be allergic to research drugs; 9. Persons who do not complete chemotherapy because of social or geographical factors; 10. Significant weight loss =10% during 6 weeks before enrollment; 11. Uncertainties affecting the safety or compliance of subjects; 12. contraindications for hormonal use.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression free survival;overall survival; | — |
Countries
China
Contacts
Public ContactJing Yan
The Comprehensive Cancer Centre of Drum Tower Hospital, Medical School of Nanjing University &Clinical Cancer Institute of Nanjing University
Outcome results
None listed