Head and neck squamous cell carcinoma
Conditions
Interventions
Group 1:3Gy/f tiw
Group 2:3Gy/f biw
Group 3:4Gy/f biw
Group 4:4Gy/f qw
Sponsors
Sichuan Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Aged over 18 years, gender is not limited; 2. ECOG PS score: 0~2 points; 3. Histological or cytologically diagnosed head and neck squamous cell carcinoma; 4. According to the eighth edition of clinical tumor TNM stage, stage III, IVa and IVb head and neck squamous cell carcinoma, and all patients have been determined by the Multidisciplinary Team Discussion (MDT) of Sichuan Provincial Cancer Hospital as unresectable or unsuitable for surgery (there are anesthesia or surgical contraindications), or the patient refuses surgery. Criteria for determining non-resection by surgery include, but are not limited to, invasion of the carotid artery, invasion of the base of the skull or bone of the cervical spine, invasion of the nasopharynx or other base of the skull tissue; 5. Patients who have progressed after surgery or after chemotherapy/immunotherapy and have not undergone local radiotherapy, are not suitable for surgery after MDT discussion; 6. Vital organ function meets the following requirements (no blood components or cell growth factors are allowed for 2 weeks before the start of study and treatment): (1) Blood routine examination shall comply with: 1) The absolute count of neutrophils (ANC) >=1.5x10^9/L; 2) Hemoglobin (HB) >=9g/dL; 3) Platelet (PLT) >=100x10^9/L; 4) Serum albumin (ALB) >=2.8g/dL; (2) Biochemical examination shall comply with: 1) Total bilirubin (TBIL) =50ml/min (Cockcroft-Gault formula); (3) Normal cardiopulmonary function; 7. Expected survival >= 3 months; 8. Patients voluntarily joined the study and signed an Informed Consent Form (ICF) with good compliance and follow-up.
Exclusion criteria
Exclusion criteria: 1. The patient has distant metastasis; 2. Patients with recurrence had previously received radiotherapy; 3. The patient had active infection and unexplained fever >=38.5? within 7 days prior to medication; 4. Other patients deemed unsuitable for inclusion by treating physicians.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum tolerated dose; | — |
Secondary
| Measure | Time frame |
|---|---|
| Dose-limiting toxicity;Objective response rate;Progression-free survival;Overall survival; | — |
Countries
China
Contacts
Public ContactZhang Shichuan
Sichuan Cancer Hospital
Outcome results
None listed