Early Recurrent Nasopharyngeal Cancer: the Effect of Surgery vs IMRT

Local and regional recurrence is a common cause of failure after primary radiotherapy for nasopharyngeal carcinoma. Radiotherapy and surgery are the treatments of choice for recurrent NPC. This study aims to compare 3 year overall survival(OS) rate of surgery versus IMRT.A stratified-block randomized approach will be used to randomly assign patients into two treatment groups after stratification according to N staging (N0 vs non-N0). Patients with rNPC will be recruited and randomized into two groups in 1:1 ratio. The primary outcomes will be 3 year overall survival(OS), the secondary outcome measures will be PFS,LPFS,RPFS,DMFS,and toxicities.Assessment will be performed at baseline and during 3 years post-randomization.

Inclusion criteria

• Diagnosed of recurrent nasopharyngeal carcinoma by pathology or imaging study;
• Stage T1 or T2 according to AJCC 8th edition ;
• Aged 18 to 70 years;
• Without metastasis;
• previously received 1 course of radiotherapy;
• Without radiotherapy within 1 year, without local treatment for recurrent disease;
• Surgical resectable and IMRT suitable;
• If regional recurrence presented, regional lesion can be treated with local treatments.
• ECOG score 0 or 1;
• Sufficient organ function;
• Acceptable approach of contraception.

Exclusion criteria

• Refuse to sign inform consent;
• Radiation encephalopathy or leptomeningeal disease (LMD);
• History of radioactive particle planting;
• Have uncontrolled intercurrent illnesses which will interfere with the ability to undergo therapy;
• With prior malignancy (excluding adequately treated basal cell or squamous cell skin cancer, in-situ cervical cancer );
• Any contradiction to surgery;
• Have any co-existing condition that would preclude full compliance or safety with the study;
• Presence of a significant neurological or psychiatric disease, including dementia and seizures;
• Uncontrolled infectious diseases;
• Female patients who are at pregnancy or lactation.
• Without personal freedom or independent civil capacity.
• With serious autoimmune disease.
• Participants of other interventional clinical trial.