Head and neck cancer
Conditions
Interventions
Experimental group:Sparing superficial lobe of parotid gland,Dmean<26Gy, V26<35%
Control group:Limit the whole parotid gland dose for V36<50%
Sponsors
The First People's Hospitao of Foshan
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Newly histologic diagnosis of nasopharyngeal carcinoma, oropharyngeal carcinoma, hypopharyngeal carcinoma, supraglottic laryngeal carcinoma for radical radiotherapy or postoperative adjuvant radiotherapy; 2. No history of radiotherapy; 3. No dry mouth symptoms before treatment, normal parotid gland function, no parotid gland basic disease; 4. Male or non-pregnant or lactating female; 5. Aged 18-70 years; 6. No evidence of distant metastasis; 7. KPS >=70; 8. WBC count >= 4x10^9/L, neutrophils count >=4x10^9/L, Hemoglobin >=90g/L,platelet count >=100x10^9/L; 9. ALT or AST <2.5 ULN, bilirubin <1.5 ULN, Serum creatinine <1.5 ULN; 10. Informed consent has been signed.
Exclusion criteria
Exclusion criteria: 1. Prior radiotherapy to the head and neck region. 2. Pre-existing xerostomia or impaired parotid gland function, including tumor invasion of the parotid gland, parotitis or parotid neoplasms, prior parotid surgery, or any treatment that may affect parotid function. 3. Primary tumor or cervical lymph nodes that are too large to meet the dose constraints of this study. 4. History or presence of another malignancy whose primary site or histology differs from the tumor being evaluated in this study, except for cervical carcinoma in situ, cured basal cell carcinoma, superficial bladder tumors (Ta, Tis, T1), or any cured cancer for which treatment was completed more than 3 years prior to study enrollment. 5. Concurrent uncontrolled serious diseases, such as infectious, rheumatic, or metabolic diseases. 6. Patient non-compliance, or inability to complete the entire study as judged by the investigator. 7. Severe dysfunction of vital organs (heart, brain, lungs, etc.). 8. Prophylactic use of amifostine or pilocarpine-class drugs.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of serious xerostomia (>=grade2); | — |
Secondary
| Measure | Time frame |
|---|---|
| Regional failure-free survival;Local failure-free survival;Overall survival;Distant metastasis free survival;Subjective evaluation of xerostomia;Objective evaluation of xerostomia;Quality of life; | — |
Countries
China
Contacts
Public ContactHaijun Wu
The First People's Hospitao of Foshan
Outcome results
None listed