Nasopharyngeal carcinoma
Conditions
Interventions
Individualized follow-up after nasopharyngeal carcinoma treatment group:None
Sponsors
Sun Yat-sen University Cancer Center
Eligibility
Sex/Gender
All
Age
16 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1) Nasopharyngeal carcinoma diagnosed by pathology, with a non-keratinizing type (according to the World Health Organization's, WHO, pathological classification); 2) No evidence of distant metastasis at initial diagnosis (M0); 3) Age between 16 and 70 years; 4) ECOG performance status score: 0 to 1; 5) Completion of radiotherapy according to the treatment course; 6) Completion of the first efficacy assessment within 4 to 16 weeks after the end of treatment; 7) The first efficacy evaluation with EBV-DNA quantitative testing at 0, and imaging assessment of nasopharyngeal tumor and cervical lymph nodes as CR (Complete Response); 8) Patients must be informed of the main content of this study and sign an informed consent form, and must be willing and able to comply with the visits, laboratory tests, and other requirements specified by the study protocol.
Exclusion criteria
Exclusion criteria: 1) Pathological type is WHO's keratinizing squamous cell carcinoma or basaloid squamous cell carcinoma; 2) Received surgery, or biological, immunological, or targeted therapy while undergoing the recommended induction chemotherapy; 3) The treatment is palliative; 4) History of previous malignant tumors, except for basal cell carcinoma or squamous cell carcinoma that has been adequately treated, and cervical carcinoma in situ; 5) Women who are pregnant or breastfeeding (pregnancy tests should be considered for women of childbearing age; effective contraception should be emphasized during the treatment period); 6) Received other radiotherapy before radical radiotherapy (except for non-melanoma skin cancer where the previous lesion is outside the target area of the radiotherapy); or the primary lesion and cervical metastatic lesion have undergone chemotherapy or surgical treatment; 7) Accompanied by other serious underlying diseases that may pose significant risks or affect the compliance of the trial. For example: unstable heart disease requiring treatment, kidney disease, chronic hepatitis, poorly controlled diabetes (fasting blood sugar > 1.5×ULN), and mental illness; 8) The first efficacy evaluation after treatment is more than 180 days from the end of radiotherapy; 9) The first efficacy evaluation after treatment is for residual tumors (including nasopharyngeal primary lesions and cervical metastatic lesions, with skull base bone destruction not included in the evaluation) and distant metastasis; 10) EBV-DNA quantitative testing is not zero on two consecutive occasions at the end of the treatment (within 1 week before and after the end of radiotherapy).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of early failure events.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Cost-effectiveness of follow-up.;Overall Survival Time;Quality of Life after Treatment;Disease-Free Failure Time";Distant Metastasis-Free Survival;Local Recurrence-Free Survival;Regional Recurrence-Free Survival; | — |
Countries
China
Contacts
Public ContactSun Ying
Sun Yat-sen University Cancer Center
Outcome results
None listed