Early Recurrent Nasopharyngeal Cancer: the Effect of Surgery vs IMRT

A Multicenter Randomized Controlled Trial for Comparing Endonasal Surgery and Radiation Therapy (IMRT) for T1-T2 Recurrent Nasopharyngeal Carcinoma

This study is a multicenter RCT to compare 3-year overall survival(OS) rate, progression free survival(PFS),local progression free survival(LPFS),regional progression free survival(RPFS),distant metastasis free survival(DMFS), and toxicities of endonasal endoscopic surgery versus 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:

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

Exclusion Criteria:

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