nasopharynx cance
Conditions
Interventions
control group:no-radiotherapy
Sponsors
Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: To be eligible for the study, patients had to meet all of the following criteria: 1. Provided written informed consent before performing any trial-related procedures; 2. No gender limit, age =18 years old, =70 years old; 3. Histologically confirmed and investigator-assessed NPC, including keratinizing carcinoma, non-keratinizing differentiated carcinoma, and undifferentiated carcinoma; Nasopharyngeal carcinoma according to investigator assessment (cT1-4N0-3M0, AJCC, 8th edition); 4. (1) For N0 patients, if the tumor invaded the structure draining from zone IB (such as the oral cavity and the anterior half of the nasal cavity), they were also eligible for enrollment. (2) For N1-3, any of the following high-risk factors should be met: a) submandibular gland invasion; b) The maximum diameter of lymph nodes in region II was =2cm; c) extracapsular invasion or necrosis of lymph nodes in level II; d) Extracapsular invasion or necrosis of lymph nodes in other regions of the neck (i.e., regions other than level II); e) Multi-station cervical lymph node involvement (e.g., simultaneous lymph node metastasis in levels II, III, IV, and V). 5. Have not received any previous systemic antitumor therapy for locally advanced disease; 6. ECOG score 0-1; 7. Adequate organ function, subject must meet the following laboratory indicators: a) absolute neutrophil count (ANC) =1.5x109/L without granulocyte colony-stimulating factor for the last 14 days. b) platelets =100×109/L in the absence of blood transfusion for the past 14 days. c) hemoglobin =9 g/dL (90 g/L) or =5.6 mmol/L in the past 14 days without blood transfusion or erythropoietin use; d) Total bilirubin =1.5× upper limit of normal value (ULN); Or total bilirubin >1.5×ULN but direct bilirubin = ULN e) aspartate aminotransferase (AST), alanine aminotransferase (ALT) =2.5×ULN, or =5×ULN in subjects with liver metastasis; f) serum creatinine =1.5×ULN and creatinine clearance (calculated by Cockcroft-Gault formula) =60 ml/min; g) Good coagulation function: 1) INR or prothrombin time (PT) =1.5 times ULN; Or the subject is receiving anticoagulant therapy, but the prothrombin time (PT) or partial thromboplastin time (PTT) is within the therapeutic range for the intended use of the anticoagulant; 2) activated partial thromboplastin time (aPTT) or partial thromboplastin time (PTT) =1.5 times ULN; Or the subject is receiving anticoagulant therapy, but the prothrombin time (PT) or activated partial thromboplastin time (PTT) is within the therapeutic range for the intended use of the anticoagulant; h) euthyroidism, defined as thyroid stimulating hormone (TSH) within the normal range. If the baseline TSH was beyond the normal range, the subjects could be included if the total T3 (or FT3) and FT4 were within the normal range. i) myocardial enzymes within the normal range (simple laboratory abnormalities that were judged by the investigators to be clinically insignificant were also allowed); 8. For women of childbearing age, a negative urine or serum pregnancy test should be performed. Women who were not of reproductive age were defined as being at least 1 year postmenopausal, or having undergone surgical sterilization or hysterectomy.
Exclusion criteria
Exclusion criteria: Subjects who met the following criteria were not eligible for inclusion in the study: 1. Nasopharyngeal carcinoma (keratinized or non-keratinized) with enlarged lymph nodes in region IB but confirmed metastasis by ultrasound-guided biopsy; 2. Head and neck squamous cell carcinoma with a nonnasopharyngeal primary site. (3) Other types other than keratinizing and non-keratinizing nasopharyngeal carcinoma; 4. Currently participating in interventional clinical research treatment; 5. Untreated active hepatitis B (defined as both HBsAg positivity and HBV-DNA copies greater than the upper limit of normal in the laboratory of the participating center); Note: Subjects with hepatitis B who met the following criteria were also eligible for inclusion: 1) Subjects with HBV viral load 140 mmHg, diastolic blood pressure > 90 mmHg); 5) patients had a history of noninfectious pneumonia requiring glucocorticoid treatment within 1 year before the first dose of glucocorticoid, or current clinically active interstitial lung disease; 6) active pulmonary tuberculosis; 7) presence of active or uncontrolled infection requiring systemic therapy; 8) presence of clinically active diverticulitis, abdominal abscess, or gastrointestinal obstruction; 9) liver diseases such as cirrhosis, decompensated liver disease, acute or chronic active hepatitis; 10) poorly controlled diabetes (fasting blood glucose (FBG) > 10mmol/L); 11) Urine routine test showed urinary protein =++ and confirmed 24-hour urinary protein quantitation > 1.0 g; 12) patients with mental disorders who are unable to cooperate with treatment; 9. Medical history or evidence of disease, treatment or laboratory abnormalities, or other conditions that may interfere with the results of the trial, prevent the participant from participating in the study fully, or other potential risks considered by the investigator to be inappropriate for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| regional relapse-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| overall survival;local relapse-free survival;distant metastasis-free survival;AEs;quality of life; | — |
Countries
China
Contacts
Public ContactJinming Yu/ Man Hu
Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences
Outcome results
None listed