Nasopharyngeal Carcinoma
Conditions
Interventions
treatment group:IMRT without involved neck regions
control group:IMRT with involved neck regions
Sponsors
Department of Oncology of the Second Affiliated Hospital of Army Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Selection criteria related to diseases: (1) Histologically proven malignant tumor of locally advanced NPC; (2) Life expectancy 3 months or longer; (3) KPS score >= 70; (4) Be tolerated with radiotherapy; (5) Without autoimmune disease; (6) Before radiotherapy, patients were treated with 2-4 cycles of induction chemotherapy combined with CPIs. The tumor response was evaluated as CR/PR, and EBV nucleic acid decreased by more than 50% of the baseline value or reduced to the normal range. 2. Adequate hematologic and end organ function, defined by the following laboratory results: (1) One week before enrollment, the bone marrow and liver and kidney function of the subjects reached the following standards: 1) Hemoglobin >= 90 g/L, ANC >= 1.5 x 10^9/L without granulocyte colony-stimulating factor support, Platelet count >= 100 x 10^9/L; 2) Serum bilirubin = 60 mL/min, urea nitrogen =18 years.
Exclusion criteria
Exclusion criteria: 1. 1. Exclusion criteria related to diseases: (1) Prior conventional radiotherapy or immunotherapy for NPC; (2) Treatment with any other investigational agent or participation in another clinical trial; (3) Malignancies other than NPC within 5 years prior to randomization; (4) There is local lymph node necrosis or capsule invasion. 2. General exclusion criteria: (1) History of any systemic diseases including: active infections, uncontrolled hypertension, congestive heart-failure, myocardial infarction, severe arrhythmia, liver, kidney or metabolic diseases; (2) Subjects with active chronic hepatitis B or active hepatitis C. Subjects with positive HBsAg or HCV antibody in the screening period must undergo further quantitative detection of hepatitis B virus (HBV) DNA (excluding more than 2,500 copies [CPS]/mL or 500 IU/mL) and HCV RNA detection (excluding exceeding the detection limit of the assay) can only be included in the trial after the active hepatitis B or hepatitis C infection requiring treatment is excluded. Hepatitis B virus carriers, patients with stable hepatitis B after drug treatment (DNA titer should not be higher than 2,500 copies [CPS]/mL or 500 IU/mL) and patients with cured hepatitis C can be enrolled; (3) History of organ transplantion; (4) History of alcohol or drug abuse; (5) Any other condition that contraindicates the use of radiation or that may affect the interpretation of the results or render the patient at high risk from treatment complications; (6) History of other malignant tumor diseases within 5 years; (7) Have a history of congenital or acquired immunodeficiency; (8) History of autoimmune diseases; (9) Patients with mental disorders or mental diseases cannot cooperate with the treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Regional relapse-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival;Overall survival;Local recurrence free survival;distant metastasis free survival;Objective response rate;Toxicity and quality of life;Disease control rate; | — |
Countries
China
Contacts
Public ContactGuanghui Li
Department of Oncology of the Second Affiliated Hospital of Army Medical University
Outcome results
None listed