Head and neck malignant tumors
Conditions
Interventions
Experimental group:Only irradiate the primary tumor bed (the target area includes the surgical cavity and the adjacent high-risk areas), without performing prophylactic
Control group:Irradiation of the primary tumor bed + bilateral cervical lymphatic drainage areas from I to VI zones
Sponsors
The first hospital of China Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1.Age: 18 years and above and 70 years and below; 2.The pathological diagnosis was squamous cell carcinoma of the head and neck. 3.Received radical surgery, with the primary lesion and cervical lymph nodes being completely removed. The postoperative pathology confirmed that the resection margin of the primary lesion was negative (R0, the microscopic resection margin was at least 1 mm away from normal tissue). 4.Undergo neck lymph node dissection, with a total number of dissected lymph nodes >= 15. Postoperative pathology confirmed that all dissected lymph nodes were negative (pN0). 5.The postoperative pathological stage was pT3-4N0 (according to the 8th edition of AJCC); applicable to the oral cavity, oropharynx (p16 negative), larynx, nasal cavity and paranasal sinuses (including maxillary sinuses), etc. 6.No evidence of distant metastasis (M0); 7.Having indications for postoperative radiotherapy, based on at least one of the following high-risk factors: nerve invasion, vascular invasion, close resection margin (1-5 mm), or invasive tumor margin. 8.ECOG physical status score of 0-1, or Karnofsky performance score of >=70; 9.Voluntarily participate and sign a written informed consent form;
Exclusion criteria
Exclusion criteria: 1.The primary sites were p16-positive oropharyngeal cancer, hypopharyngeal cancer and tongue cancer. 2.Before the preoperative neoadjuvant therapy, the imaging or pathological diagnosis was N3 stage (according to the 8th edition of the AJCC: the maximum diameter of cervical lymph nodes was > 6 cm, or the metastatic lymph nodes were located below the lower edge of the cricoid cartilage); 3.Within 2 to 4 weeks after the completion of preoperative neoadjuvant therapy (chemotherapy, immunotherapy, or combined therapy), an imaging assessment indicated disease progression (in accordance with the RECIST 1.1 standard); 4.There was any lymph node metastasis in the postoperative pathology (pN+), or the total number of lymph nodes removed from the neck was less than 15. 5.Positive surgical margin (R1: microscopic margin < 1 mm; R2: macroscopic margin positive); 6.Had previously received radiotherapy for the head and neck region; 7.Previous history of head and neck surgery (excluding diagnostic biopsies); 8.Pregnant or lactating women; 9.Severe functional impairments of organs such as the heart, liver and kidneys, making it impossible to tolerate radiotherapy. 10.Also suffering from other active malignant tumors; 11.Plan to receive immunotherapy during the postoperative radiotherapy period, or have a history of congenital or acquired immune deficiency diseases; 12.There are contraindications for radiotherapy, or the patient is unable to cooperate with long-term follow-up.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence rate of grade 3 and above radiation-induced lymphopenia; | — |
Secondary
| Measure | Time frame |
|---|---|
| Acute radiation injury;Two-year regional control rate;Two-year disease-free survival rate;Two-year overall survival rate;Late radiation injury;Nutritional status;Quality of life; | — |
Countries
China
Contacts
Public ContactQiao Qiao
The first hospital of China Medical University
Outcome results
None listed