At present, the main treatment for recurrent nasopharyngeal carcinoma (rNPC) is re-irradiation. Conventional external irradiation can result in a high incidence of side effects. Intensity modulated radiation therapy and stereotactic radiotherapy can not only reduce the radiation dose to vital organs and surrounding normal tissues, but also improve local control rate. Brachytherapy and surgery are also shown to be effective in early diseases.

Local recurrent nasopharyngeal carcinoma(NPC) presents a troublesome challenge to radiation oncologist. Reirradiation is the primary modality nowadays. However, clinical data on reirradiation are still relatively scarce. This article summarized the treatment advances and the clinical characteristics associated with relapse of NPC, and reviewed the outcomes of different radiation techniques in the management of recurrence of NPC, i.e. conventionalradiotherapy, stereotactic radiotherapy, brachytherapy, three-dimensional conformal radiotherapy and intensity modulate radiotherapy, or some combination of above in recent years.

The authors briefly introduced the management of clinical test for new drug development, clinical trials for drugs prepared in hospital and post-market drugs, and other types of clinical trials. The mechanism of WHO International Clinical Trial Register Platform (WHO ICTRP), Chinese Clinical Trial Register (ChiCTR) and Chinese Clinical Trial Registration and Publishing Collaboration (ChiCTRPC) were also introduced. The authors suggested the trialists to practice the basic philosophy of evidence-based medicine as the rules of their thought and action, and considered that this is the inner guarantee system for the validity of clinical trials.

Traditional Chinese medicine (TCM) intervention should be concisely and precisely reported in randomized controlled trials (RCTs). Based on State Food and Drug Administration's categories, we recommend reporting the interventions as follows: (1) Single Chinese herbal medicine-based/formula-based/extraction-based intervention includes 1) Name, dosage format and registration; 2) The composition and quality of intervention; 3) Pharmaceutical processing and quality control; 4) Stability of final product and quality control; 5) Function and safety description; 6) Dosage and treatment course; 7) Control group. (2) Active compound-based TCM drug intervention includes 1) Name of active compound(s); 2) Original source of active compound(s); 3) The brief process obtaining active compound(s); 4) Percentage of active compound(s) in final product; 5) Added materials and its quality and quantity control. Besides, the detailed information of intervention can be published as an online supplement in web site.

Evaluating outcome is the primary means by which different medical modalities can be compared with regard to effectiveness. In traditional Chinese medicine (TCM), this focus has prompted practitioners to search for outcome measures that can objectively verify the effectiveness of TCM interventions, especially in the context of randomized controlled trials (RCTs). Commonly used indexes for outcome assessment in RCTs of TCM can be categorized into two types: TCM-specific outcomes such as tongue and pulse characteristics, and Western medicine (WM)-specific outcomes such as blood test and X-ray examination results. Some studies include both types of indicators. During the trial design, it is necessary to consider the rationales of selecting outcome assessments, the purpose and study approach, balance between objective and subjective indexes, standardization of outcome assessment, and standardized outcome indexes. We recommend to report the outcome assessment in RCTs of TCM in the following format: 1) identifying the primary and secondary outcomes based on the purpose and hypothesis of the trial; 2) defining the primary and secondary outcomes clearly; 3) presenting the rationale of selection; 4) presenting the method with aims to standardize the assessment process; 5) presenting the method to improve the reliability of assessment; and 6) stating the termination criteria in the trial.

Objective To establish a post?treatment prognostic score model for newly diagnosed metastatic nasopharyngeal carcinoma, and to investigate the feasibility of stratified therapy. Methods A total of 263 eligible patients with newly diagnosed metastatic nasopharyngeal carcinoma from 2002 to 2010 were enrolled as subjects. The primary tumor was treated with conventional radiotherapy, three?dimensional conformal radiotherapy, or intensity?modulated radiotherapy, and radiation areas included nasopharyngeal tumor and cervical lymphatic drainage region. The metastatic bone tumor was mainly treated with conventional external radiotherapy, while the metastatic liver or lung tumor was mainly treated with surgical resection, radiotherapy, or radiofrequency ablation. The first?line therapy for most of patients was cisplatin?based combination chemotherapy. Factors including the general characteristics, tumor status, and therapy for patients were involved in multivariate analysis, and a prognostic model was established based on the n value (HR=en ) of the prognostic factors. Results The factors influencing the overall survival (OS) in patients were a Karnofsky performance score (KPS) not higher than 70(P= 0?? 00), multiple organ metastases (P=0?? 00), combination with liver metastasis (P= 0?? 00), a number of metastases not less than 2(P= 0?? 00), a level of lactate dehydrogenase (LDH) higher than 245 IU/ L (P= 0?? 00), a number of chemotherapy cycles ranging between 1 and 3( P= 0?? 00), a poor response for metastatic tumor ( stable disease or progressive disease)(P= 0?? 00), and primary tumor not treated with radiotherapy (P= 0?? 01). Based on the prognostic score, patients were divided into low?risk group (0?1?? 5 points), intermediate?risk group (2?? 0?6?? 5 points), and high?risk group (≥7?? 0 points), and the 5?year OS rates in the three groups were 59?? 0%, 25?? 1%, and 0%, respectively. Conclusions The prognostic score model based on the KPS, serum level of LDH, multiple organ metastases, combination with liver metastasis, and number of metastases can effectively predict the survival in patients. Active treatment including at least 4 chemotherapy cycles and radiotherapy for primary tumor can prolong the survival time of patients in the low?and intermediate?risk groups. However, patients in the high?risk group were mainly treated with palliative radiotherapy due to no improvement in the survival by radiotherapy for primary tumor.

Objective To investigat the prognostic value of overall treatment time (OTT) for locally advanced nasopharyngeal carcinoma (NPC) treated with intensity-modulated radiation therapy (IMRT).Methods From May 2001 to April 2007, 376 patients with locally advanced NPC treated with IMRT were retrospectively analyzed.All patients were divided into OTT≤45 days group and OTT >45 days group.The treatment outcomes between the two groups were analyzed.Results Between the groups with OTT≤45 days and OTT > 45 days, the 2-year local control rate (LCR) was 94.9% and 93.1% (χ2= 2.83, P > 0.05) for all patients, 96.3% and 98.7% (χ2=2.83, P>0.05) for patients with T3 disease, 92.2% and 83.1%(χ2= 6.30, P < 0.05) for T4, and 93.1% and 97.5% (χ2= 4.69, P = 0.030) when chemotherapy was concurrently administered.The 2-year LCR was 98%, 96% and 93% (χ2= 2.20, P = 0.531) for patients with treatment interruption before, within and after the 3rd week of IMRT, The Cox regression analysis found that OTT was an independent prognostic factor for LCR in T4 disease.The Linear regression showed that the 2-year LCR was decreased by 2.7% per day of delay.Between the groups with OTT≤45 days and OTT >45days, the 2-year estimated disease-specific survival (DSS), distant metastasis-free survival (DMFS) and overall survival (OS) were 84.1% vs.78.7% (χ2= 0.02, P = 0.881), 87.0% vs.86.1% (χ2= 0.85,P = 0.358), and 91.7% vs.92.2% (χ2= 0.06, P = 0.806), respectively.The further stratified analysis found that the DSS, DMFS and OS were similar between the two groups in T3 (83.7% vs.83.2%, χ2=0.07, P=0.798;86.6% vs.85.7%,χ2=0.02, P = 0.898 ; and 93.7% vs.94.8%,χ2=0.03, P=0.862) and T4 disease (81.4% vs.72.3%, χ2= 0.16, P = 0.687 ;82.6% vs.86.9%, χ2= 1.78, P =0.182;and 88.3% vs.87.5% ,χ2=0.60, P =0.438).In multivariate analysis, T-stage and N-stage were the independent prognostic factors for both DFS and OS, and N-stage was the independent prognostic factor for DMFS.Conclusions The prolongation of the overall treatment time decrease the local control of patients with T4 NPC.

Objective To compare the Chinese'92 and 2008 staging systems of nasopharyngeal carcinoma (NPC) based on the long term survival of the patients. Methods Clinical data of 498 NPC patients treated with definitive IMRT were retrospectively analyzed. The distributions of patients in the two staging systems were compared. The long term outcomes according to T, N and overall stages in each system were evaluated. Kappa value and Pearson coefficient were used to evaluate the agreement and correlation of the two systems. Results The distributions of both T and N stage between'92 and 2008 stage systems were different. In both staging systems, the local recurrence-free survival (LRFS) curves of T_1, T_2 andT_3 were close up (even overlaped), though they were apart from T_4. The distant metastasis-free survival (DMFS) curves overlaped of N_1 and N_2 in the'92 staging system, while separated of N_1, N_2 and N_3 in the 2008 staging system. Significant difference of DMFS was not found between N, and N_2 in'92 staging system, while did exist among N_0, N_1, N_2 and N_3 stages in 2008 staging system. In the both staging systems, the disease-specific survival (DSS) of stage Ⅰ did not significantly differ from that of stage Ⅱ or Ⅲ. The statistical analysis showed the conformality of DSS curves in the two system was 89% (Kappa =0. 833 ,P <0.01), with agood relative rate (r=0. 919,P<0. 01). Conclusions The difference between'92 and 2008 staging system is mainly in N stage. The 2008 N stage seems more reasonable compared with'92 N stage, which is able to better forecast the DMFS. There are some agreements and correlations between the two staging systems.