Nasopharyngeal carcinoma
Conditions
Interventions
Group 1:Selective cervical lymph node dissection within 3-6 months after radiotherapy
Group 2:Observation after radiotherapy until progress of the cervical lymph node, then to dissection
Sponsors
Sun Yat-sen University Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: The specific criteria are as follows: Diagnostic criteria for cervical lymph node residue: Patients with suspected cervical lymph node residuals within 3-6 months after radiotherapy, underwent at least two of neck MRI, neck color ultrasound and PET-CT, who were considered diagnosis of residual lymph nodes in combination with imaging examination by the attending radiotherapy doctor and head and neck surgeon. Diagnostic criteria for progression of cervical lymph node residue: (1) The enrolled patients underwent neck color ultrasound monitoring every 3-6 months. If lymph node progression was considered, neck MRI or PET/CT was performed. Both examinations indicated residual lymph node enlargement, and which were considered diagnosis of the progression of lymph node residual in combination with imaging examination by the attending radiotherapy doctor and head and neck surgeon; (2) Pathologically confirmed undifferentiated non-keratinizing carcinoma; (3) In addition to radical chemoradiotherapy, the primary patients have not received other anti-tumor treatments; (4) Male or female, aged 18-65 years; (5) Adequate liver function: total bilirubin = upper limit of normal (ULN); AST and ALT = 2.5 times upper limit of normal (ULN); Alkaline phosphatase = 5 times the upper limit of normal (ULN); (6) Adequate renal function: creatinine clearance rate = 80 mL / min; (7) Adequate blood function: absolute neutrophil count (ANC) = 2×10^9/L, platelet count = 100×10^9/L and Hemoglobin =9g/dL; (8) There is no serious dysfunction of vital organs such as heart and lung; (9) PS score = 2 points (SEE ATTACHMENT); (10) Sign the informed consent form.
Exclusion criteria
Exclusion criteria: (1) Accompanied by residual nasopharyngeal or residual retropharyngeal lymph node, with history of other malignant tumors; (2) Distant metastasis; (3) Women who are pregnant or breastfeeding; (4) Disagree to sign the informed consent form; (5) Unable to cooperate with regular follow-up due to psychological, social, family and geographic reasons; (6) Receiving experimental treatment from other clinical studies (in the treatment period of clinical research); (7) Accompanied by a serious uncontrollable infection or medical disease; (8) Major organ dysfunction, such as decompensated heart, lung, kidney, liver failure, which cannot tolerate surgical treatment; (9) Laboratory tests: total bilirubin >upper limit of normal (ULN); AST and/or ALT >1.5 times upper limit of normal (ULN) with alkaline phosphatase >2.5 times upper limit of normal (ULN); (10) Factors affecting surgery or anesthesia, such as severe organ dysfunction, etc; (11) Long-term use of immunosuppressive agents after organ transplantation; (12) With a history of other malignant tumors before enrolled.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 5-year overall survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| 5-year progression-free survival;regional recurrence free survival;distant disease free survival; | — |
Contacts
Public ContactMing Song
Sun Yat-sen University Cancer Center
Outcome results
None listed