Head and Neck Squamous Cell Carcinoma
Conditions
Interventions
ARM I:None
Experimental group:Metronomic capecitabine
Sponsors
Sun Yat-Sen University Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 70 years; 2. ECOG physical condition score: 0~1 points; 3. Initially diagnosed stage III-IV head and neck squamous cell carcinoma (according to the 8th edition AJCC staging criteria), the primary site is the oral cavity, oropharynx, larynx or hypopharynx; 4. Received any of the following treatment options: (1) Radical surgery + postoperative radiotherapy ± concurrent chemotherapy; (2) Neoadjuvant therapy + radical radiotherapy ± concurrent chemotherapy; (3) Concurrent chemoradiotherapy. 5. For patients who have undergone radical surgery, postoperative radiotherapy (chemotherapy) should be started within 4-8 weeks after surgery and completed as planned; 6. Within 4-8 weeks after completing the recommended postoperative or radical radiotherapy (chemotherapy); 7. No evidence of local residual or distant metastasis was found in patients before enrollment; 8. The function of major organs is good, that is, within 2 weeks before enrollment: (1) Blood routine examination: hemoglobin > 90 g/L; neutrophil count > 1.5×10^9/L; platelet count > 100x10^9/L; (2) Biochemical tests: total bilirubin = 50 ml/min. 9. The subjects voluntarily joined the study, signed the informed consent form, had good compliance, and cooperated with the follow-up.
Exclusion criteria
Exclusion criteria: 1. p16 positive; 2. Known to be intolerant to capecitabine, or allergic to its excipients; 3. There are multiple factors that affect oral drugs (such as inability to swallow, chronic diarrhea, and intestinal obstruction, etc.); 4. There is a history of malignant tumor in the past, except for fully treated basal cell carcinoma or squamous cell carcinoma and cervical carcinoma in situ; 5. Women who are pregnant or breastfeeding (pregnancy test should be considered for women of childbearing age; effective contraception should be emphasized during treatment); 6. Received anti-tumor treatment such as surgery, chemotherapy, and radiotherapy for head and neck tumors in the past (except diagnostic treatment); 7. During radiotherapy, received surgical treatment, or biological and immunotherapy at the same time; 8. After radiotherapy, are receiving or are expected to receive other chemotherapy drugs, or biological and immunotherapy; 9. With other serious diseases, it may bring greater risks or affect the compliance of the test. For example: unstable heart disease requiring treatment, kidney disease, chronic hepatitis, poorly controlled diabetes mellitus (fasting blood glucose > 1.5 x ULN), and psychiatric disease.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| overall survival;distant failure-free survival;locoregional failure-free survival;Adverse events;Patient reported quality-of-life score; | — |
Countries
China
Contacts
Public ContactMao Yanping
Sun Yat-Sen University Cancer Center
Outcome results
None listed