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 discuss the types of control groups in randomized controlled trials (RCTs) of Chinese herbal medicine (CHM), and to provide suggestions for improving the design of control group in future clinical studies in this therapeutic area. METHODS: A search of the Cochrane Library was conducted in July 2005 to identify RCTs of CHM, and 66 RCTs with CHM for type 2 diabetes mellitus were obtained as the basis for further analysis. RESULTS: Of 66 RCTs with CHM for type 2 diabetes mellitus, 61 (92.4%) trials had both a treatment group and a control group. Twenty-seven (40.9%) RCTs compared CHM plus conventional drug vs conventional drug, 24 (36.4%) compared CHM vs conventional drug, 5 (7.6%) compared CHM vs placebo, 3 (4.5%) compared CHM plus conventional drug vs conventional drug plus placebo, 3 (4.5%) compared CHM plus conventional drug vs other CHM, 1 (1.5%) compared CHM vs no treatment, 1 (1.5%) compared CHM plus placebo vs conventional drug plus placebo, 1 (1.5%) compared CHM vs CHM plus conventional drug vs conventional drug vs placebo, and 1 (1.5%) compared CHM vs conventional drug vs CHM plus conventional drug. CONCLUSION: A variety of control groups were used in RCTs of CHM for type 2 diabetes mellitus, including placebo, active, and no treatment control groups. Justification for selecting particular types of control groups were not provided in the trials reviewed in this study. Different control groups may be appropriate according to the study objectives, and several factors should be considered prior to selecting control groups in future RCTs of CHM. RECOMMENDATIONS: (1) Investigators of CHM who design clinical trials should understand the rationale for selecting different types of control groups; (2) Control groups for RCTs should be selected according to study objectives; (3) Active control groups should select interventions for comparisons that have the strongest evidence of efficacy and prescribe them as recommended; (4) Placebo control groups should select a placebo that mimics the physical characteristics of test intervention as closely as possible and is completely inert; (5) No treatment control groups should only be used when withholding treatment is ethical and objectives outcomes will not be subject to bias due to absent blinding; (6) Crossover control groups may be appropriate in chronic and stable conditions.

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.