Surgery is so far the most effective treatment for early-stage non-small cell lung cancer (NSCLC). Since the 1990s, the pathology spectrum of early-stage lung cancer has gradually changed because of the increased detection of ground-glass opacity (GGO). The findings from preoperative thin-section computed tomography are strong predictors for the invasiveness and lymph node involvement of GGO, and limited surgery is believed to be implemented safely for radiological less invasive lesions, which calls into question the dominance of lobectomy. After the JCOG0201 trial establishing the radiologic criteria of pathological noninvasiveness for lung adenocarcinoma, the Japan Clinical Oncology Group (JCOG) and the West Japan Oncology Group (WJOG) have successively carried out a series of prospective imaging-guided trials to investigate the optimal surgical procedure for early-stage lung cancer. JCOG0804, was a single-arm, non-randomized, confirmatory trial to evaluate the efficacy and safety of sublobar resection (wedge resection and segmentectomy) for GGO dominant peripheral lung cancer. The primary end point was 5-year relapse-free survival. JCOG0802/WJOG4607L, was a multicentre, open-label, phase 3, randomized, controlled, non-inferiority trial to investigate if segmentectomy was non-inferior to lobectomy in patients with small-sized peripheral NSCLC. The primary endpoint was 5-year overall survival. JCOG1211 was also a non-randomized confirmatory trial to confirm the efficacy of a segmentectomy for clinical T1N0 lung cancer with dominant GGO. The primary endpoint was 5-year relapse-free survival. The findings of JCOG0804 and JCOG0802, and the primary analysis results of JCOG1211 have been officially published. This article systematically reviewed and interpreted the results of the JCOG lung cancer surgery trial series.
Carcinoma, Non-Small-Cell Lung/surgery* ; Clinical Trials as Topic ; Clinical Trials, Phase III as Topic ; Humans ; Japan ; Lung Neoplasms/surgery* ; Multicenter Studies as Topic ; Prospective Studies ; Randomized Controlled Trials as Topic

Electronic case report forms (eCRFs) instead of the traditional paper case report forms (pCRFs) are increasingly used by investigators and sponsors of clinical research. We include a total of 14 phase III studies (8 pCRF, 6 eCRF) to compare paper and electronic data documentation both quantitatively and qualitatively in clinical studies. The result suggests that adaptions of electronic data capture (EDC) in clinical trials have the advantages in optimization of data capture process, improvement of data quality and earlier clinical decision compared to paper-based methods. Furthermore, the successful implementation of EDC requires accouplements with corresponding data management processes and reallocation of resources.
Clinical Trials, Phase III as Topic ; Data Collection ; methods ; Information Storage and Retrieval ; methods ; Medical Informatics

The developments of medicine always follow innovations in science and technology. In the past decade, such innovations have made cancer-related targeted therapies possible. In general, the term "targeted therapy" has been used in reference to cellular and molecular level oriented therapies. However, improvements in the delivery and planning of traditional radiation therapy have also provided cancer patients more options for "targeted" treatment, notably stereotactic radiosurgery (SRS) and stereotactic body radiotherapy (SBRT). In this review, the progress and controversies of SRS and SBRT are discussed to show the role of stereotactic radiation therapy in the ever evolving multidisciplinary care of cancer patients.
Clinical Trials, Phase III as Topic ; Humans ; Lung Neoplasms ; surgery ; Neoplasms ; surgery ; Radiosurgery ; Radiotherapy Dosage ; Survival Rate

Differentiated thyroid cancer can be effectively treated with high-dose 131I and the other head and neck cancer can also be effectively treated with extra-radiotherapy, but these treatments often result in a reduction in salivary gland function, causing xerostomia. Collectively, these effects can lead to severe secondary complications, including difficulty in speaking and swallowing, decreasing appetite even affecting nutrition and sleep. Amifostine, an analog of cysteamine, is a phosphorlyated aminothiol prodrug and its active metabolite, WR-1065 etc, can selectively protect normal tissues from the cytotoxic effects of drugs and/or radiation while preserve antitumor effects. Many studies have demonstrated that amifostine protects normal tissues from both acute and late extra-radiation damage without protecting the tumor. It has been approved by FDA to be used for protecting the salivary gland from xerostomia caused by radiotherapy. It has also show protecting effects on intra-radiotherapy, but there are many problems waiting for study.
Amifostine ; adverse effects ; therapeutic use ; Animals ; Clinical Trials as Topic ; Clinical Trials, Phase II as Topic ; Clinical Trials, Phase III as Topic ; Cytoprotection ; Head and Neck Neoplasms ; drug therapy ; radiotherapy ; Humans ; Rabbits ; Radiation Injuries ; prevention & control ; Radiation-Protective Agents ; pharmacology

Azacitidine ; analogs & derivatives ; therapeutic use ; Clinical Trials, Phase III as Topic ; Humans ; Leukemia, Myeloid, Acute ; drug therapy ; Multicenter Studies as Topic

Immune thrombocytopenia (ITP) is a common acquired hemorrhagic disease. Conventional view considered its pathogenesis as the destruction of platelets induced by platelet associated antibodies, the target of treatment are inhibiting the production of antibodies and blocking the destruction of platelets in reticuloendothelial system, but they are ineffective in part of ITP patients, who transform to chronic/refractory ITP (C/RITP). As to children's C/RITP, the effect of first-line therapy is low, while the second-line therapy isn't effective definitely and has obvious side effects. The safe and effective second-line drugs to prevent disease progressing are urgently required. Recently, a pathogenesis that decrease the platelet production has been confirmed, thrombopoietic drugs, including thrombopoietin (TPO) and its receptor agonist (TRA), are under research and clinical application gradually. Recombinate human TPO (rhTPO) has accomplished Phase III clinical trails in adult C/RITP and tumor children. The Phase III clinical trails of romiplostim and eltrombopag, as the representative of TRA, in adult C/RITP have been performed. There are also two clinical trails of TRA for children's C/RITP, the efficacy and safety have been approved, with the convenience for using. In pediatric population, they have a good clinical application. In this article the research and development of thrombopoietic drugs and their perspective in pediatric clinical use are reviewed.
Child ; Clinical Trials, Phase III as Topic ; Humans ; Thrombocytopenia ; drug therapy ; etiology ; Thrombocytopenia, Neonatal Alloimmune ; drug therapy ; Thrombopoietin ; therapeutic use

In recent years, based on the phase III clinical study, postoperative chemoradiation, perioperative chemotherapy with ECF regimen and postoperative adjuvant chemotherapy with oral S-1 have become the standard adjuvant treatment of resectable gastric adenocarcinoma in the United States, Europe, and Japan, respectively. Since the Southwest Oncology Group in 2001 reported a large phase III randomized clinical trial INT0116, adjuvant chemoradiotherapy has become a standard treatment for gastric adenocarcinoma. With the rapid development of chemoradiotherapy technique, clinical researches for using operation combined with chemoradiotherapy to treat gastric adenocarcinoma emerged one after another, including adjuvant postoperative chemoradiation, preoperative chemoradiation, and chemoradiation combined with intraoperative radiotherapy and so on. This review will summarize the recent treatment protocol using chemoradiotherapy for resectable gastric adenocarcinoma, and comprehensively evaluate the clinical value and significance of chemoradiotherapy for resectable gastric adenocarcinoma.
Chemotherapy, Adjuvant ; Clinical Trials, Phase III as Topic ; Combined Modality Therapy ; Humans ; Perioperative Care ; Radiotherapy, Adjuvant ; Randomized Controlled Trials as Topic ; Stomach Neoplasms ; drug therapy ; radiotherapy ; surgery

OBJECTIVETo evaluate the effects of antiviral nucleotide/nucleoside analogues (NUCs) and interferon (IFN) on liver fibrosis and progression to cirrhosis in patients with hepatitis B virus (HBV) infection.

METHODSThe literature databases of PubMed (1966 to 2011), Embase (1966 to 2011), Wanfang database (1998 to 2011), Chinese National Knowledge Infrastructure (CNKI; 1997 to 2010), and Chinese Biomedical (CBMdisc; 1860 to 2011) were searched for studies that met the following criteria: (1) case-control phase III clinical trails that used only one kind of antiviral drug (NUCs or IFN), with the controls receiving placebo or no treatment; (2) analysis of biopsy specimens collected before and after treatment for both the cases and controls; (3) assessment of fibrosis as an outcome measure of the treatment's effect. The data from all 11 studies included in the meta-analysis were extracted and analyzed by the RevMan5.1 software.

RESULTSNUC treatment significantly regressed liver fibrosis, as compared with placebo treatment (33.7% vs. 19.2%, relative risk (RR): 1.82, 95% confidence interval (CI): [1.47, 2.25], P less than 0.01). NUC treatment significantly reduced the progression of fibrosis, as compared with placebo treatment (9.1% vs. 24.8%, RR: 0.33, 95% CI: [0.19, 0.58], P less than 0.01). IFN treatment significantly reduced progression of fibrosis, as compared with no treatment (23.8% vs. 30.7%, RR: 0.48, 95% CI: [0.34, 0.69], P less than 0.01). IFN significantly reduced progression to cirrhosis, as compared with no treatment (10.6% vs. 18.0%, RR: 0.62, 95% CI: [0.44, 0.88], P less than 0.01).

CONCLUSIONOne year of NUC treatment could partly regress liver fibrosis and partly reduce the progression of fibrosis, while one year of IFN treatment could reduce the progression of fibrosis and cirrhosis.

Antiviral Agents ; pharmacology ; therapeutic use ; Clinical Trials, Phase III as Topic ; Hepatitis B, Chronic ; complications ; drug therapy ; Humans ; Liver Cirrhosis ; drug therapy ; etiology ; virology

Signal transduction in cells plays an important role in the process of cellular metabolism, segmentation, differentiation, biological behaviors and cell death. Direct and indirect involvement of kinases in tumor growth, metastasis and apoptosis make them the most promising targets for anticancer discovery. Most of the kinase inhibitors in clinical use or in late development stages are multi-target kinase inhibitors (MTKIs). These MTKIs are demonstrated to exert potent anti-tumor effects through several different pathways. This review presents in the view of a medicinal chemistry point, a brief account and analysis of transduction pathways of representative MTKIs in clinical use or in late development stages.
Antineoplastic Agents ; therapeutic use ; Clinical Trials, Phase III as Topic ; Drug Delivery Systems ; methods ; Humans ; Neoplasms ; drug therapy ; Protein Kinase Inhibitors ; therapeutic use ; Signal Transduction

Small cell lung cancer is a kind of malignant tumor with strong invasiveness and poor prognosis, and the classic therapeutic modality of the disease remains multidisciplinary and comprehensive treatment. Treatment options for small cell lung cancer have been stalled for a long time, and new opportunities have emerged in recent years due to the development and initial experience of immunotherapeutic drugs. Clinical trials of some selected immune checkpoint inhibitors have confirmed the efficacy and safety in small cell lung cancer. Based on the results of phase III clinical trials (Impower133 and CASPIAN), Atezolizumab or Durvalumab in combination with chemotherapy has been approved by the U.S. Food and Drug Administration for the first-line treatment of extensive-stage small cell lung cancer. Clinical trials involving immune checkpoint inhibitors are being actively carried out and provide different perspectives for the management of small cell lung cancer. This article aimed to review the clinical progress in immunotherapy of small cell lung cancer.
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Clinical Trials, Phase III as Topic ; Humans ; Immune Checkpoint Inhibitors ; Immunologic Factors/therapeutic use* ; Immunotherapy/methods* ; Lung Neoplasms/pathology* ; Small Cell Lung Carcinoma/pathology*